Onyda XR (clonidine hydrochloride), the first and only liquid non-stimulant ADHD medication approved in the U.S., and the only such medication with nighttime dosing, became available nationwide for the treatment of attention deficit hyperactivity disorder (ADHD) on October 1. ¹

The U.S. Food and Drug Administration (FDA) approved Onyda XR on May 24 as a monotherapy ADHD treatment or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

Tris Pharma developed Onyda XR with its proprietary LiquiXR® technology, which converts immediate-release drugs into extended-release formulations for once-daily dosing. Onyda XR is considered a centrally acting alpha2-adrenergic agonist medication that belongs to the same class of drugs as Guanfacine (Intuniv) and clonidine (Kapvay).

Patients with ADHD who experience adverse side effects from stimulants or who respond poorly to stimulant medications may find symptom relief in a non-stimulant medication. A systematic review and meta-analysis published in May by Neuroscience & Biobehavioral Reviews reported that non-stimulant medication is nearly as effective as stimulant medication at improving executive function in children, adolescents, and adults with ADHD. ²

Combination Therapy for ADHD

In addition, clinicians may prescribe Onyda XR along with a stimulant to treat ADHD symptoms. Combination therapy is becoming an increasingly popular option for patients who need longer durations of drug coverage than a stimulant dose can provide on its own or who hope to avoid common stimulant side effects.

“Most of the medicines we use for ADHD are safe in combination with other medications,” said Timothy E. Wilens, M.D., chief of child and adolescent psychiatry and co-director of the Center for Addiction Medicine at Massachusetts General Hospital, during the ADDitude webinar “Combination Therapy: Medication Strategies for Hard-to-Treat Complex ADHD.” “Certain combinations, such as stimulants plus clonidine or guanfacine, are FDA approved, and they wouldn’t be unless they were deemed effective and safe.”

Guanfacine ER (Intuniv) and clonidine ER (Kapvay), received FDA approval for the treatment of ADHD in patients 6 to 17 years old as monotherapy and as adjunctive therapy to stimulant medications in 2009 and 2010, respectively.

If a stimulant does not address symptoms at standard dosages, “it usually makes more sense to treat remaining symptoms with a second medication,” said Oren Mason, M.D., a physician at Attention MD in Grand Rapids, Michigan.

“Most adult patients in my practice who take extended-release stimulants need average to high dosages to achieve optimal symptom reduction,” Mason said. “They typically report 8 to 10 hours of medication benefit, and most require short-acting supplements to treat their evening symptoms. In contrast, most patients on combination therapy take low- to moderate stimulant dosages and report a duration of benefits of more than 12 hours.”

Mason said he finds that many adult patients using combination therapy decrease their stimulant dosages and experience fewer side effects than do patients taking only stimulants. “Waking up was less torturous, and getting ready for school was smoother,” he said. “Family life was better, without the meltdowns that many families accept as ‘normal’ as stimulants wear off.”

Anthony Rostain, M.D., M.A., professor of psychiatry and pediatrics at the Perelman School of Medicine at the University of Pennsylvania, recommends that clinicians consider several factors before prescribing combination therapy.

“The important thing to keep in mind if you’re combining agents,” he said, “is to be sure that the patient understands how to use each one and how to dose each one. They need to understand the inherent challenges they’re going to face, and make sure you’re paying attention to the side effects that might emerge from the combination of stimulant and non-stimulant.”

The FDA based its approval for Onyda XR on studies of clonidine hydrochloride extended-release tablets, including two 8-week, placebo-controlled trials evaluating 256 patients, as well as a 40-week, placebo-controlled, randomized-withdrawal study evaluating the drug in 135 pediatric patients aged 6 to 17 years. ³, ⁴

According to Onyda XR prescribing information, the most common adverse reactions with the medication’s use as monotherapy include somnolence, fatigue, irritability, nightmares, insomnia, constipation, and dry mouth. The most common adverse reactions with its use as an adjunct therapy include somnolence, fatigue, decreased appetite, and dizziness. ⁵

Sources

¹Tris Pharma’s Once-Daily ADHD Medication, ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, Now Available in the United States. News Release. Tris Pharma. October 1, 2024. Accessed October 2, 2024. https://www.businesswire.com/news/home/20241001522635/en/Tris-Pharma–Once-Daily-ADHD-Medication-ONYDA-XR-clonidine-hydrochloride-Extended-Release-Oral-Suspension-Now-Available-in-the-United-States

²Isfandnia, F., Masri, S.E., Radua, J., & Rubia, K. (2024) The Effects of Chronic Administration of Stimulant and Non-Stimulant Medications on Executive Functions in ADHD: A Systematic Review and Meta-Analysis. Neuroscience & Biobehavioral Reviews; 162. https://doi.org/10.1016/j.neubiorev.2024.105703

³Jain, R., Segal, S., Kollins, S.H., Khayrallah, M. (2011). Clonidine Extended-Release Tablets for Pediatric Patients with Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. https://doi.org/10.1016/j.jaac.2010.11.005

⁴Kollins, S.H., Jain, R., Brams, M., Segal, S., Findling, R.L., Wigal, S.B., Khayrallah, M. (2011). Clonidine Extended-Release Tablets as Add-On Therapy to Psychostimulants in Children and Adolescents with ADHD. Pediatrics. https://doi.org/10.1542/peds.2010-1260

⁵ Highlights of Prescribing Information. Onyda XR. FDA. Accessed May 29, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s000lbl.pdf

Since October 2022, thousands of individuals with ADHD have faced immense difficulty accessing prescribed stimulant medication – the treatment they need to function and lead healthy lives. No relief is in sight.

Make no mistake that the reason for the ongoing stimulant shortage has much to do with how stimulant medication itself is viewed. After all, the Drug Enforcement Administration (DEA) classifies stimulants as Schedule II drugs for their “high potential for abuse” and sets national drug quotas for these substances based on that classification.^{1 2} This drug quota is, arguably, a major factor driving the shortage.³

Like many psychiatrists, I have taken the Schedule II classification of stimulants at face value for most of my career. Prescription stimulants are Schedule II, so they must be very addictive. How do I know? Because they are Schedule II.

This circular thinking has stopped me – and likely others – from noticing the mismatch between this classification and what I observe clinically. And while it may seem like the Schedule II classification is set in stone, it isn’t. In fact, the Controlled Substances Act specifically states that organizations, or even individuals, may petition the DEA to reclassify a substance.⁴ Shouldn’t we at least question whether these medications belong in Schedule II?

Controlled Substances: What We Get Wrong About Stimulants for ADHD

The DEA classifies drugs into five distinct categories depending upon their medical use and potential for abuse or dependency. Schedule V drugs have the lowest potential for abuse, while Schedule I drugs have a high potential for abuse and no current accepted medical use.

[Read: “Stop Treating Us Like We’re Addicts!”]

While working as a community psychiatrist, I used to brace myself for the bad outcomes from prescription stimulants. After all, as Schedule II drugs, they sit way up in the DEA’s scale. But what I found was that carefully prescribed stimulants rarely caused issues, whereas other drugs deemed “safer” often did.

Take benzodiazepines, drugs that are used to treat conditions like anxiety and insomnia. With benzodiazepines, tolerance and dependence are common, the withdrawal syndrome is serious, and overdoses can be lethal, especially when combined with opioids. When used long-term, the taper can be rocky and often requires several months to complete.

Comparatively, standard prescription stimulant treatment has minor problems. Withdrawal syndromes are rare and brief. While I have seen occasional misuse, I haven’t seen prescription stimulant overdoses or use disorders. Rather, I’ve seen people gain control of their lives. They graduate college, they hold jobs, and their relationships improve. Early refill requests are rare.

People who are prescribed scheduled benzodiazepines rarely miss a dose and need no reminders. Most of my patients with ADHD, however, struggle to take medications every day and may forget to fill their medications on time.

[Read: “This Cannot Be the Price We Pay to Function.”]

For All Their Dangers

The stark difference in adherence between benzodiazepines and prescription stimulants likely reflects two things: the symptoms of ADHD itself and the fact that stimulant medications, when taken as prescribed, are much less reinforcing compared to benzodiazepines.

Just ask any child who takes Quillivant, a banana-flavored liquid form of methylphenidate, if they want their morning dose. Many will run, far. Beer and coffee are acquired tastes because the brain pairs their flavors with the good feeling that follows consumption. The ‘drug liking’ effect of alcohol and caffeine reinforces a desire for the taste — a phenomenon that hardly occurs when taking stimulants as prescribed for ADHD. Coffee and alcohol, despite their abuse potential and widespread use, are freely available to most of the public.

Benzodiazepines, for all their dangers, are Schedule IV. Meanwhile, prescription stimulants sit in the Schedule II Hall of Shame, along with fentanyl. Yes, fentanyl – a substance 50 times more potent than heroin and responsible for a majority of the thousands of overdose deaths in the United States in 2023.^{5 6} Surely, there must be a classification error here, right?

National overdose deaths involving prescription stimulants is difficult to track because of a coding issue that lumps prescription stimulants with illicit methamphetamines. Fortunately, one study separated the two by looking at substance-related death certificates from 2010 to 2017. Of the 1.2 million total deaths that involved substances, only 0.7% involved prescription stimulants, often used in combination with other substances. Methylphenidate-related deaths accounted for .02% (295) of all substance use-related deaths, or an average of 37 deaths per year.  Compared to methylphenidate, there were twice as many deaths involving pseudoephedrine (615), which does not require a prescription, and 160 times more illicit methamphetamine-related deaths (49,602).⁷

Stimulants Are Safe – and Life-Saving – When Used as Prescribed

The sparsity of stimulant prescription-related deaths may reflect their essential role in treatment. ADHD is associated with greater risk for accidents, injury, premature death, and suicide.⁸ Multiple studies suggest that treatment with prescription stimulants may lower the risk of these adverse and deadly events.^8-11

Unfortunately, the serious risks of illicit methamphetamine use can drive stigma and fear toward prescription stimulants. Many people with ADHD may be hesitant to start stimulants for concerns about heart problems and addiction. While illicit methamphetamine does cause major heart problems and is highly addictive, appropriate prescription stimulant treatment does not carry this risk.^12, 13 Even in overdose, major cardiovascular events are rare.¹⁴ Multiple studies also show that prescription stimulant treatment for ADHD does not increase the risk of developing a substance use disorder (SUD) and may even have a protective effect.^{15, 16}

Importantly, there are situations, namely non-oral misuse (e.g., snorting, smoking, or injecting), where prescription stimulants do have high potential for abuse. These routes allow stimulants to enter the brain rapidly and cause a rapid spike in dopamine. The faster and bigger the spike, the more intense the “high” or “drug liking” effect that will reinforce use. Oral routes, on the other hand, more slowly deliver drugs to the brain. This is partly why stimulants, when taken as prescribed, hold a much lower addiction potential.¹⁷

Most people with ADHD will never snort or inject their medications. People without ADHD usually won’t, either. Indeed, the Schedule II classification appears to be on behalf of a subset of people, with and without ADHD, who use stimulant medications non-orally. Arguably, a more tailored way to protect this group may lie on the diagnostic side — by taking a careful history, requiring drug screens in adolescents and young adults, and considering non-stimulants when the risks are too high. Many youth will also welcome a matter-of-fact discussion on substance use and harm reduction.

On Stimulant Misuse

A more common issue is oral prescription stimulant misuse — that is, taking someone else’s medication or too much of your own. A 2022 survey showed that 15% of college students reported taking someone else’s prescription stimulant at least once in their lifetime, but most did so less than once a month. Only 0.1% of students reported misusing prescription stimulants more than four times per month.¹⁸

Most college students report misusing prescription stimulants for perceived performance enhancement.¹⁹ The misuse pattern does not tend to escalate and is lower-risk in nature. This is likely because most students who misuse will only do so orally, which is much less addictive, and they are not using to get high. Some of this misuse may also be an effort to self-medicate. A 2010 study showed that prescription stimulant misusers were seven times more likely to screen positive for ADHD compared to non-misusing students.²⁰

To be clear, it is still a bad idea to misuse prescription stimulants. While the health risks do not appear to warrant schedule II classification, that does not mean “risk free.” All prescription medications carry risks, and risks can vary based on factors like dose, route, and the individual. What is safe for one person can be dangerous for another. For instance, someone with bipolar disorder can become manic from a prescription stimulant. Someone who regularly uses illicit methamphetamine may tolerate high doses of prescription stimulants whereas someone else may become agitated, psychotic or go into renal failure at a much lower dose.¹⁴

For those at higher risk for prescription pill misuse, there are also long-acting formulations that were designed to prevent non-oral use. For instance, Concerta (methylphenidate ER) has a hard outer coating that is very difficult to crush.²¹ This will deter most people. In addition, when studied in a group of adolescents with ADHD and an SUD, Concerta rated only one point higher than placebo in “drug-liking” effect.²²

Vyvanse (lisdexamfetamine) is another long-acting formulation that deters abuse. Vyvanse comes as an inactive prodrug and won’t activate until it is converted by an enzyme in the bloodstream. Even if someone snorts or injects it, it will still need to be converted to an active form in the body and will not produce a more rapid effect. Two “drug-liking” studies also suggest lower abuse potential with IV doses not differing from placebo.^{23 24} While a supratherapeutic oral dose had some “liking,” it also measured higher on “drug-disliking.”²⁴

Reclassifying prescription stimulants to a lower tier would more accurately reflect real-world data on addictive potential, health risk, and their public health benefit. Still, any reclassification to a lower tier carries the risk of fueling misconceptions about safety. Some may mistake reclassification as a green light to misuse. Misconceptions on safety may also drive the purchase of counterfeit pills. Make no mistake: Counterfeit prescription stimulants – which can be easily purchased online – kill people. These fake pills are made to look just like real prescription stimulants, but instead contain illicit methamphetamine and/or fentanyl, in unpredictable amounts. Taking even one counterfeit pill can be lethal.²⁵

Prescription stimulant misuse, as a whole, is a problem that deserves our attention. Targeted education needs to occur at the individual, family and school levels. This may include dispelling myths on cognitive enhancement, emphasizing the higher risk with non-oral use, and increasing awareness on counterfeit pills. When young people are taught the actual risks and realities of the current drug landscape, they are given a chance to make safer choices. This strategy is rooted in connecting with at-risk youth and can happen without interfering with the treatment of people with ADHD.

Schedule II Drugs: The Case for Reclassifying Stimulant Medication

Ensuring access to stimulant treatment is essential to the lives of millions of people with ADHD, and it benefits the public at large. While there is widespread oral misuse, the use does not tend to escalate. Non-oral use is higher risk, but less common and rarely fatal, making prescription stimulants an outlier in the Schedule II class.

Prescription stimulants are long overdue for reclassification. For those still on the fence, here is a more conservative approach: Start with rescheduling medications that have abuse-deterring properties, such as Concerta, Vyvanse, and their generic equivalents. By releasing these medications from the chains of Schedule II, more people with ADHD can live their lives.

Do you think prescription stimulants should be reclassified? Share your thoughts in the comments section.

Schedule 2 Drugs and Stimulants: Next Steps

• Read: Who’s Afraid of ADHD Stimulants?
• Read: The Real Reason ADHD Medication Supply Is Lagging Demand
• Read: “The DEA’s Manufactured Crisis”

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Sources

¹ Drug Enforcement Administration. Drug Scheduling. DEA.gov. https://www.dea.gov/drug-information/drug-scheduling

² 21 CFR Part 1303. https://www.ecfr.gov/current/title-21/chapter-II/part-1303

³ Committee on Oversight and Accountability. (May 14, 2024) Comer, McClain Probe Shortages of Schedule II Drugs, including Adderall. https://oversight.house.gov/release/comer-mcclain-probe-shortages-of-schedule-ii-drugs-including-adderall%EF%BF%BC/

⁴ Drug Enforcement Administration. The Controlled Substances Act. DEA.gov. https://www.dea.gov/drug-information/csa

⁵ Drug Enforcement Administration. Fentanyl. DEA.gov. https://www.dea.gov/factsheets/fentanyl

⁶ Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2024. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

⁷ Black, J. C., Bau, G. E., Iwanicki, J. L., & Dart, R. C. (2021). Association of medical stimulants with mortality in the US from 2010 to 2017. JAMA Internal Medicine, 181(5), 707–709. https://doi.org/10.1001/jamainternmed.2020.7850

⁸ Li, L., Zhu, N., Zhang, L., Kuja-Halkola, R., D’Onofrio, B. M., Brikell, I., Lichtenstein, P., Cortese, S., Larsson, H., & Chang, Z. (2024). ADHD pharmacotherapy and mortality in individuals with ADHD. JAMA, 331(10), 850–860. https://doi.org/10.1001/jama.2024.0851

⁹ Krinzinger, H., Hall, C. L., Groom, M. J., Ansari, M. T., Banaschewski, T., Buitelaar, J. K., Carucci, S., Coghill, D., Danckaerts, M., Dittmann, R. W., Falissard, B., Garas, P., Inglis, S. K., Kovshoff, H., Kochhar, P., McCarthy, S., Nagy, P., Neubert, A., Roberts, S., Sayal, K., … ADDUCE Consortium (2019). Neurological and psychiatric adverse effects of long-term methylphenidate treatment in ADHD: A map of the current evidence. Neuroscience and Biobehavioral Reviews, 107, 945–968. https://doi.org/10.1016/j.neubiorev.2019.09.023

¹⁰ Chang, Z., Quinn, P. D., O’Reilly, L., Sjölander, A., Hur, K., Gibbons, R., Larsson, H., & D’Onofrio, B. M. (2020). Medication for attention-deficit/hyperactivity disorder and risk for suicide attempts. Biological Psychiatry, 88(6), 452–458. https://doi.org/10.1016/j.biopsych.2019.12.003

¹¹ Chang, Z., Quinn, P. D., Hur, K., Gibbons, R. D., Sjölander, A., Larsson, H., & D’Onofrio, B. M. (2017). Association between medication use for attention-deficit/hyperactivity disorder and risk of motor vehicle crashes. JAMA Psychiatry, 74(6), 597–603. https://doi.org/10.1001/jamapsychiatry.2017.0659

¹² Manja, V., Nrusimha, A., et al. (2023) Methamphetamine-associated heart failure: a systematic review of observational studies. Heart, 109:168-177. https://doi.org/10.1136/heartjnl-2022-321610

¹³ Zhang, L., Yao, H., Li, L., Du Rietz, E., Andell, P., Garcia-Argibay, M., D’Onofrio, B. M., Cortese, S., Larsson, H., & Chang, Z. (2022). Risk of cardiovascular diseases associated with medications used in attention-deficit/hyperactivity disorder: A systematic review and meta-analysis. JAMA Network Open, 5(11), e2243597. https://doi.org/10.1001/jamanetworkopen.2022.43597

¹⁴ Martin, C., Harris, K., Wylie, C., Isoardi, K. (2023). Rising prescription stimulant poisoning in Australia: a retrospective case series. Toxicology Communications, 7(1). https://doi.org/10.1080/24734306.2023.2174689

¹⁵ Quinn, P. D., Chang, Z., Hur, K., Gibbons, R. D., Lahey, B. B., Rickert, M. E., Sjölander, A., Lichtenstein, P., Larsson, H., & D’Onofrio, B. M. (2017). ADHD medication and substance-related problems. The American Journal of Psychiatry, 174(9), 877–885. https://doi.org/10.1176/appi.ajp.2017.16060686

¹⁶ McCabe, S. E., Dickinson, K., West, B. T., & Wilens, T. E. (2016). Age of onset, duration, and type of medication therapy for attention-deficit/hyperactivity disorder and substance use during adolescence: a multi-cohort national study. Journal of the American Academy of Child and Adolescent Psychiatry, 55(6), 479–486. https://doi.org/10.1016/j.jaac.2016.03.011

¹⁷ Manza, P., Tomasi, D., Shokri-Kojori, E., Zhang, R., Kroll, D., Feldman, D., McPherson, K., Biesecker, C., Dennis, E., Johnson, A., Yuan, K., Wang, W. T., Yonga, M. V., Wang, G. J., & Volkow, N. D. (2023). Neural circuit selective for fast but not slow dopamine increases in drug reward. Nature Communications, 14(1), 6408. https://doi.org/10.1038/s41467-023-41972-6

¹⁸ The Ohio State University. (2022). College prescription drug study: Key findings. https://www.campusdrugprevention.gov/sites/default/files/2022-06/CPDS_Multi_Institutional_Key_Findings_2022.pdf

¹⁹ Faraone, S. V., Rostain, A. L., Montano, C. B., Mason, O., Antshel, K. M., & Newcorn, J. H. (2020). Systematic review: nonmedical use of prescription stimulants: risk factors, outcomes, and risk reduction strategies. Journal of the American Academy of Child and Adolescent Psychiatry, 59(1), 100–112. https://doi.org/10.1016/j.jaac.2019.06.012

²⁰ Peterkin, A. L., Crone, C. C., Sheridan, M. J., & Wise, T. N. (2011). Cognitive performance enhancement: misuse or self-treatment? Journal of Attention Disorders, 15(4), 263–268. https://doi.org/10.1177/1087054710365980

²¹ Cone E. J. (2006). Ephemeral profiles of prescription drug and formulation tampering: evolving pseudoscience on the internet. Drug and Alcohol Dependence, 83 Suppl 1, S31–S39. https://doi.org/10.1016/j.drugalcdep.2005.11.027

²² Winhusen, T. M., Lewis, D. F., Riggs, P. D., Davies, R. D., Adler, L. A., Sonne, S., & Somoza, E. C. (2011). Subjective effects, misuse, and adverse effects of osmotic-release methylphenidate treatment in adolescent substance abusers with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 21(5), 455–463. https://doi.org/10.1089/cap.2011.0014

²³ Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. Journal of Psychopharmacology. 2009;23(4):410–8
https://citeseerx.ist.psu.edu/document?repid=rep1&type=pdf&doi=8ead4bf37b0e1111a740fe2ce34ebced83085c3c

²⁴ Jasinski DR, Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. Journal of Psychopharmacology. 2009;23(4):419–27
https://journals.sagepub.com/doi/10.1177/0269881109103113

²⁵ https://www.dea.gov/sites/default/files/2021-05/Counterfeit%20Pills%20fact%20SHEET-5-13-21-FINAL.pdf

Relexxii (generic name: methylphenidate HCI ER) is a once-daily, extended-release, central nervous system (CNS) stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults up to the age of 65 and pediatric patients six years of age and older. The safety and effectiveness of Relexxii for pediatric patients under age six are unknown.

According to the U.S. Food and Drug Administration (FDA), Relexxii is a federally controlled substance. “Schedule II Stimulants” are believed to have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

What Ingredients Are in Relexxii?

Relexxii contains methylphenidate hydrochloride salt, the same active ingredient as ADHD medications, such as Ritalin, Daytrana, Concerta, and Aptensio XR. Relexxii contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, and triacetin.

How Does Relexxii Work?

Relexxii uses osmotic delivery technology, releasing the medication at a controlled rate throughout the day. Relexxii comes in tablet form and has a semipermeable membrane with an immediate-release drug overcoat, an osmotically active bilayer core containing the drug and excipients, and a push layer containing osmotically active components. The immediate-release drug overcoat dissolves within one hour, providing an initial dose of medication. The push layer in the tablet’s core expands and pushes the drug through a laser-drilled orifice at a controlled release rate throughout the day for 6 to 7 hours. The Relexxii tablet releases medication without dissolving its outer shell. The outer shell passes through the digestive tract and out of the body without being digested.

How Do You Use Relexxii?

Relexxii tablets should be taken orally once daily in the morning, with or without food, and must be swallowed whole with a full glass of water or another liquid. Never cut, crush, or chew the tablets because this would destroy the time-release mechanism.

What Is the Typical Dosage for Relexxii?

Relexxii is available in flexible dosing options that support targeted titration and eliminate the need for multiple pills. Daily dosages above 54 mg in pediatric patients 6 to 12 years and above 72 mg in pediatric patients 13 to 17 years have not been studied and are not recommended. Daily dosages above 72 mg are not recommended in adults.

The optimal dosage varies from patient to patient. Your doctor may adjust your daily dosage by small increments until you or your child experiences the greatest improvement in symptoms without side effects.

For updated information about dosages, interactions, and precautions, see the Relexxii drug monograph on WebMD.

Relexxii vs. Concerta

Relexxii and Concerta are both brand names for methylphenidate HCI. Relexxii and Concerta both use osmotic delivery technology, which releases the medication at a controlled rate throughout the day. In a study of 60 healthy volunteers, a once-daily dose of Relexxii 72-mg demonstrated bioequivalence to a twice-daily dose of Concerta (methylphenidate HCI) 36-mg tablets. ¹, ²

On June 23, 2022, the FDA approved Vertical Pharmaceuticals’ Relexxii for ADHD in adults (up to 65 years old) and pediatric patients six years of age and older.

Concerta received FDA approval for treating ADHD on August 1, 2000.

What Side Effects Are Associated with Relexxii?

As with all ADHD medications, follow your Relexxii prescription instructions exactly. Taking Relexxii late in the day can disrupt sleep.
The most common side effects of Relexxii reported by adults include:

• decreased appetite
• headache
• dry mouth
• nausea
• insomnia
• anxiety
• dizziness
• weight loss
• irritability
• increased sweating

Less common side effects of Relexxii include:

• priapism (an erection that does not subside)
• circulation problems in fingers and toes, including Raynaud’s Phenomenon
• eyesight changes or blurred visions

The most common side effect reported in pediatric patients taking Relexxii was upper abdominal pain. There has been some concern that stimulants may cause a slowing of growth in children and adolescents. However, research findings revealed mixed results. Some studies show no impact on growth at all ³, while others find what is considered a “negligible” slowing of growth. ⁴ Talk to your doctor if you find evidence of suppressed growth or weight in your child.

If side effects are bothersome or do not disappear, talk to your doctor. Most people taking this medication do not experience any of these side effects. See the full list of possible Relexxii side effects here.

What Precautions Are Associated with Relexxii?

Patients with known structural cardiac abnormalities, cardiomyopathy, severe heart rhythm abnormalities, coronary artery disease, and other serious heart problems should avoid using Relexxii. Patients should monitor their heart rate and blood pressure regularly while taking Relexxii, as increases may occur. Patients with a personal or family history of high blood pressure, heart problems, or heart defects should share this with their HCP.

Relexxii may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder or induce a manic or mixed episode in patients with bipolar disorder. Before initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depression, a family history of suicide, and bipolar disorder). If new psychotic or manic symptoms occur, consider discontinuing Relexxii.

Before initiating Relexxii, healthcare providers should assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. They should also regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.

Because the Relexxii tablet is nondeformable and does not appreciably change in shape in the GI tract, Relexxii should not be administered to patients with preexisting severe gastrointestinal narrowing (e.g., esophageal motility disorders, small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel’s diverticulum).

An ophthalmologist should evaluate any Relexxii-treated patients at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia).

The effects of Relexxii on an unborn child are not yet clear. Tell your doctor if you plan to become pregnant, are pregnant, or are breastfeeding before taking Relexxii. Women exposed to Relexxii during pregnancy or breastfeeding may participate in the National Pregnancy Registry for Psychiatric Medications to improve existing safety information.

What Interactions Are Associated with Relexxii

You should not take Relexxii if you have any of the following conditions:

• allergy or hypersensitivity to methylphenidate HCI or any of the ingredients in methylphenidate medications
• anxiety/agitation
• glaucoma
• tics or history of Tourette’s syndrome
• circulation problems
• esophagus, stomach, or intestine problems
• if you are taking monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment
• if you are taking risperidone.

Share a list of all vitamin or herbal supplements and prescription and non-prescription medications you take with the pharmacist when you fill your prescription. Inform all doctors and physicians that you are taking Relexxii before surgery or laboratory tests. Relexxii can have a dangerous interaction with certain anesthetics.

For a complete list of all possible drug interactions, refer to Relexxii’s drug label information for consumers and healthcare professionals.

Sources

¹ Relexxii (methylphenidate hydrochloride extended-release tablets) package insert. Vertical Pharmaceuticals, LLC; 2023.
²Data on file, Osmotica Pharmaceuticals US LLC.
³Harstad, E., Weaver, A., Katusic, S., Colligan, R.C., Kumar, S., Chan, E., Voigt, R., Barbaresi, W. (2014.) ADHD, Stimulant Treatment, and Growth: A Longitudinal Study. Pediatrics. https://doi.org/10.1542/peds.2014-0428
⁴Greenhill, L., Swanson, J., Hechtman, L., Waxmonsky, J., Arnold, L., Molina, B., Hinshaw, S., Jensen, P., Abikoff, H., Wigal, T., Stehli, A., Howard, A., Hermanussen, M., Hanć, T. (2020). Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder. Journal of the American Academy of Child & Adolescent Psychiatry. v. 59, Issue 8. 978-989. https://www.jaacap.org/article/S0890-8567(19)31443-1/fulltext/

Vyvanse and its generic equivalents (lisdexamfetamine dimesylate) may be more readily available at pharmacies following a decision by the Drug Enforcement Administration (DEA) to allow expanded production of the stimulant medication used to treat ADHD and moderate-to-severe binge-eating disorder (BED) in adults. About one-quarter of the 24% (6,236 kg) production increase in lisdexamfetamine will address domestic demand, and the remaining 75% will address foreign demand.¹

“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA said in a letter on September 5.

The DEA’s decision arrives amid a stimulant shortage that has disrupted treatment for millions of patients with ADHD for nearly two years. The U.S. Food and Drug Administration (FDA) first reported a shortfall of Adderall (the brand name for the immediate-release formulation of amphetamine mixed salts used to treat ADHD) due to manufacturing delays at Teva Pharmaceutical Industries in October 2022. The nationwide Adderall shortage triggered a domino effect, with ADHD patients struggling to fill prescriptions for other stimulant medications, such as Vyvanse and Ritalin.

In August 2023, the FDA granted approval for 15 manufacturers to produce generic Vyvanse capsules and chewable tablets after Takeda Pharmaceuticals’ U.S. patent for the medication expired.² (The FDA stipulates that generic ADHD medications contain exactly the same active ingredients as their name-brand counterparts; however, compounds in generic drugs are allowed to include different binding chemicals, fillers, and colors.) However, one year later, the promise of generic Vyvanse has done little to ease the stimulant shortfall.

As of September 9, the American Society of Health-System Pharmacists (ASHP) reported lisdexamfetamine dimesylate capsule shortages among nine drug manufacturers. Eight attributed the shortage to an “issue with the active ingredient.”

Controversy Surrounding APQs

The DEA sets yearly aggregate production quotas (APQs) for stimulant medications, which are classified as Schedule II controlled substances due to their high potential for abuse. The process has drawn the ire of many drug manufacturers, clinicians, and patients with ADHD, who cite production limits as the main reason for the stimulant shortage.

“The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication,” William Dodson, M.D., LF-APA, wrote in an ADDitude Op-Ed earlier this year. “The DEA decides how much of each medication can be released to pharmacies in any given month. Therefore, this problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it.

“This process tries to predict in March of 2024 how much medication will be needed 21 months later in December of 2025,” Dodson continued. “It is a crude and inadequate system that the DEA is too inflexible to relinquish.”

Stimulant Drug Manufacturers Speak Out

Mounting frustration over the stimulant shortage has begun influencing some positive change.

The public comment period for the DEA’s “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances” drew 4,699 comments, according to The Federal Register. (Last year, the DEA received 357 comments.)

Commentators included patients with ADHD, drug manufacturers, members of U.S. and Australian professional associations, representatives from the Royal Australian and New Zealand College of Psychiatrists, and others. They expressed concerns about the ongoing ADHD medication shortage and the DEA’s lack of transparency in setting quotas, among other issues. ³

In response, the DEA said it is “considering methods that might increase transparency in its quota-setting process,” including public notification and an opportunity for public input when prescribing rates for controlled substances substantially deviate from FDA’s estimate of medical needs. The agency is also considering regulatory changes to gain access to more real-time data, such as monthly updates in the Automated Reports and Consolidated Ordering System (ARCOS), a database where manufacturers and distributors report their controlled substances transactions to the DEA.

However, an association representing drug manufacturers asserted that the DEA’s practice of allocating procurement quotas based on a company’s historical drug sales disadvantages generic lisdexamfetamine drug manufacturers because they lack an established sales history.

The DEA disputed the claim. “DEA has always been cognizant that new manufacturers entering the market for the first time would not have any established sales history, and thus the manufacturer’s past sales history is not a factor when determining the quota needed to launch a new product,” it said in the January 3 issue of The Federal Register.³

The federal agency also denied that APQs are causing the stimulant shortage. “The DEA utilizes the available, reliable data and information received by the agency at the time APQs are proposed and proactively monitors drug production, distribution, and supply during the year,” it said. “Drug shortages may occur subsequently due to factors outside of DEA control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations.”

Drug manufacturers’ hands are not necessarily tied after the DEA releases its yearly APQs. Any DEA-registered manufacturer may apply for an increase in the manufacturing quota for a basic class of controlled substance in Schedule I or II throughout the year. The DEA must review such requests within 30 days of receipt.

The decision to raise the APQs of name brand and generic Vyvanse came at the behest of the FDA and a DEA-registered manufacturer earlier this summer. In October 2023, the DEA raised the production limits of methylphenidate (brand names: Ritalin, Concerta) by 27% after receiving requests from the FDA and a DEA-registered drug manufacturer.

It is too early to tell if the expanded Vyvanse APQs will inspire more DEA-registered drug manufacturers to request quota reviews. In the meantime, the increased production of Vyvanse and its generic equivalents will promise welcome relief to the estimated one million Americans regularly taking the stimulant.

Vyvanse was the most popular prescription stimulant, according to ADDitude’s 2023 treatment survey. Nearly one-quarter of respondents said they (or their child) were taking Vyvanse to treat ADHD symptoms, outnumbering other prescription stimulants used by ADDitude readers, including Concerta (15%), Adderall (15%), Adderall XR (13%), and Ritalin (10%).

Among ADDitude survey respondents taking Vyvanse, 44% said the medication is extremely or very effective at treating their ADHD symptoms.

“Vyvanse has, without exaggeration, changed my life and made me into the kind of person I’ve always wanted to be,” one survey respondent said.

Sources

¹Adjustment to the Aggregate Production Quota for Lisdexamfetamine and dAmphetamine (for Conversion) for 2024. Drug Enforcement Administration. The Federal Register. September 5, 2024. https://public-inspection.federalregister.gov/2024-20114.pdf

¹FDA Approves Multiple Generics of ADHD and BED Treatment. FDA. Published August 28, 2023. Accessed August 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment?utm_medium=email&utm_source=govdelivery

¹Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024. Drug Enforcement Administration. The Federal Register. January 3, 2024. https://www.federalregister.gov/documents/2024/01/03/2023-28962/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment

The upshot? Most of the survey respondents said they wish they’d started medication sooner.

Here, ADHD families share their stories of starting stimulants and non-stimulants.

“We were reluctant to use medication but decided to give it a go as our son reached an age when he could tell us if he felt it made a difference. He asked for the tablet the second day because he felt a change in his ability to concentrate.”

“I was reluctant to try medication at first, given the frightening reputation of amphetamines, but my psych provider encouraged me to look past the headlines and investigate the decades of research on stimulants and their effect on ADHD. I was reassured, took the meds, and never looked back.”

[Get This Free Resource: 2024 Scorecard of ADHD Treatments]

“For anyone out there who thinks, ‘I don’t want medication. I can treat ADHD without it,’ you’re probably wrong. I have more self-control than I’ve ever had. Maybe medication isn’t for everyone, but you’ll never know what it can do if you don’t try. Start with a very low dose if you’re nervous. Also, a balanced diet, sleep, and proper supplements have a huge impact on symptoms.”

“I had fears about how meds would affect my teenage son, so after he lost weight on the first couple of stimulants he tried, we were ready to try a non-stimulant. He’s been on it for about two months, and so far, so good.”

“By the time our son was in first grade, he was struggling every single day and was being corrected and fussed at by pretty much every adult in his life. We got him diagnosed, but my husband was adamantly against ADHD medication. The fact is, if our child had cancer or diabetes, we wouldn’t be withholding medication. My son started medication and it was absolutely the best thing we could have done for him. I only wish we’d started it earlier.”

“I wish doctors approached stimulant medications with less fear, particularly around cardiovascular risk. The willingness of at least some doctors to sacrifice treatment for ADHD, a lifelong and potentially harmful condition, in favor of a slightly lower perceived cardiac risk is a real impediment to effective treatment.”

Should I Take ADHD Medication? Next Steps

• Free Download: What to Ask Before Starting ADHD Medication
• Watch: Medication Strategies for Hard-to-Treat Complex ADHD
• Read: How Does ADHD Medication Work?
• Read: Your Top 10 Questions About ADHD Medications for Children

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Stimulant medications, mainly methylphenidate and amphetamine, remain the primary medications used to treat ADHD. For more than 80 years, stimulant medications have been used to safely and effectively treat ADHD, however some basic questions from patients linger. I’ll address a few of them here.

Q: “How Do Patients Decide Whether to Try Medication for ADHD?”

I believe people with ADHD are best served by medication. If your doctor recommends medication, try it. If it helps and doesn’t cause side effects, continue taking it under medical supervision. If the medication isn’t effective or causes side effects, talk with your doctor about alternatives.

At first, most of my patients want no part of ADHD medication. My job is to make sure they make their decisions based on facts, rather than rumors and negative press. Once they know the facts, 90% of my patients decide to give meds a try. If you don’t like the medication, stop taking it. It will be out of your system within a day. But opting not to even try medication is like saying to your eye doctor, “Let’s try a year of squinting before we try eyeglasses.”

[Free Guide: What You Need to Know About ADHD Medications]

Q: “How Do Providers Decide Which ADHD Medication to Prescribe?”

Though there are basic parameters, patients’ responses are unpredictable. How a given medication affects one person may be completely different from how it impacts someone else. So how do we decide? It’s trial and error. For the first trial, I usually offer methylphenidate (e.g., Ritalin) or amphetamine (e.g., Adderall).

Q: “What Is a Good Starting Dose of ADHD Medication?”

I start low and go slow. Prescribers may change the dose every three days if a patient is not seeing any improvement. Some people need only a small dose, while others need a bigger one. For example, Ritalin at 5mg or 10mg once or twice a day is a typical starting dose for some kids.

Once it’s established that a medication works, the prescriber may switch your child to a long-acting methylphenidate like Concerta or Ritalin LA, or a long-acting amphetamine like Vyvanse or Adderall XR, which is taken after breakfast. Some children take an immediate-release Ritalin or Adderall, which I call a “homework pill,” around 3 or 4 p.m. as well.

Q: “How Do You Know If Your Child’s ADHD Medication Is Working?”

Before your child starts medication, make a list with your doctor about what you hope it will address. You might say that you hope your child will get dressed and out the door without a struggle in the morning, that they will finish their homework more quickly, that they will be less forgetful and get better grades, and that they will be more engaged in class and less disruptive.

[Free Download: The Ultimate Guide to ADHD Medication]

Use your list as an objective measure of the medication’s effect. If you see no improvement in your child, ask your prescriber to find a dose of a medication that provides symptom improvement with no side effects (other than appetite suppression without unwanted weight loss). Keep in mind that about 20% of people with ADHD don’t benefit from any medication.

Q: “What Medication Do You Turn to If the First Two Stimulants Don’t Work?”

I might have my patients try Mydayis, a very long-acting form of amphetamine. The non-stimulants approved for ADHD include Strattera (atomoxetine); Qelbree (viloxazine); Intuniv or Tenex (guanfacine); and Kapvay (clonidine). Several medications that have proven effective for ADHD off-label include the stimulant modafinil (Provigil or Nuvigil); Wellbutrin (bupropion); and amantadine, a dopaminergic anti-viral agent that’s primarily used to treat Parkinson’s disease.

Q: “What Are the Most Common Side Effects of ADHD Medications?”

Appetite suppression in children is the most common side effect of stimulants. Less common side effects in adults and children include elevated blood pressure and heart rate, and insomnia. This is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

It’s important to monitor weight, sleep, heart rate, blood pressure, and moodiness or irritability. If you or your child has problems with moodiness, weight loss, or sleep, talk with your doctor and make changes promptly.

For further details on ADHD medications, including dosages, precautions, and interactions, visit the WebMD Drugs & Medication Database.

Managing Medications for ADHD: Next Steps

Free Download: What to Ask Before Starting ADHD Medication
Q&A: “How Do Doctors Decide Which ADHD Medication to Prescribe First?”
Read: How Safe Are ADHD Medications?
Find: ADHD Specialist or Clinic Near You

Edward “Ned” Hallowell, M.D., is a child and adult psychiatrist and a leading authority in the field of ADHD.

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This quote perfectly sums up the pervasive fear among adults and caregivers of children diagnosed with ADHD. And it remains as detrimental now as it was when authors Edward Hallowell, M.D., and John Ratey, M.D., first published it in their book ADHD 2.0 (#CommissionsEarned).

The first-line medications for ADHD are some of the most effective, best studied, most scrutinized, longest known, and safest drugs in all of medicine. They have been safely prescribed to children for decades. Nonetheless, no other class of medications in virtually all of medicine inspires more baseless fears, intentional disinformation, and wild beliefs as do the stimulants used to treat ADHD. Interestingly, these fears are almost entirely an American phenomenon that hardly exists elsewhere in the world.

ADHD and Stimulants: A Disinformation Campaign Begins

In the late 1970s, a public backlash against treating ADHD with stimulant medication began after groups launched nationally organized, and extraordinarily effective, disinformation campaigns. This instilled a climate of fear among physicians, parents, and educators, and sowed anxiety and confusion among the public. Moreover, it planted in the minds of Americans the otherwise nonsensical idea that it was the treatment of ADHD that was dangerous — not the untreated medical condition itself.

It is also important to make a distinction between side effects due to stimulant medications and those unpleasant experiences caused by poor clinician training and experience. Finding a good clinician is much more difficult than it should be. Establishment medical education has failed miserably to prepare clinicians to diagnose and treat ADHD at all ages.

[Free Download: The Caregiver’s Guide to ADHD Treatment]

The goals of medication treatment include:

• Rule #1: The right medication and dosage matched to the right person should be dramatically beneficial and have virtually no side effects.
• Rule #2: Finely tuned ADHD medication should help you be “the best version of you.”

The Dangers of Untreated ADHD

Clinical neuropsychologist Russell Barkley, Ph.D., has demonstrated that untreated ADHD is not just highly impairing, it can be deadly. In fact, having ADHD lowers a person’s estimated life expectancy by 12.7 years.¹ Barkley has noted that most of the contributors to this mortality are lifestyle-related and can be reversed with treatment.

Research shows that untreated ADHD, with its impulsivity and inattention, raises the risks for serious traffic accidents, addiction, unsafe sexual practices, and self-harm, as well as challenges with academic performance, relationship difficulties, financial struggles, and chronic stress for children, teens, and adults.

ADHD and Stimulants: Facts Over Fears

Baseless fears about stimulant medication have scared caregivers away from seeking proper treatment for their children diagnosed with ADHD. The benefits of ADHD medication, based on decades of research and medical practice, used in conjunction with cognitive behavioral therapy, are profound for many people. The risks stemming from untreated ADHD are equally profound.

[Read: What Are the Long-Term Effects of ADHD Medication on the Brain?]

These are the fears I hear most from caregivers about ADHD medication, and my responses:

Fear #1: Will medication change my child’s personality?

The first-line stimulant medications affect a person with ADHD differently than they do a neurotypical person. Stimulant medications calm and soothe the hyperarousal and loss of emotional control associated with ADHD. A neurotypical person on an ADHD stimulant, by contrast, becomes more agitated, jittery, irritable, and unable to slow down.

Fear #2: Are stimulants addictive?

Having ADHD increases a person’s risk of substance use disorder, regardless of whether they take medication. However, one large study of adolescents found that “current pharmacotherapy for ADHD is associated with lower risk for substance use problems as long as medication treatment is maintained, indicating that pharmacotherapy is likely to be a key part of efforts to reduce substance use risk in those with ADHD.²

Fear #3: What if my child loses weight on a stimulant and doesn’t grow?

Appetite suppression is a common side effect of stimulant medications that goes away when the medicine is taken consistently enough to develop a tolerance to it. Most children ultimately gain weight and grow just as they did before taking medication.

For a small portion of elementary school-age children, most of whom were already picky eaters, the side effect of appetite suppression does create a problem. If a child is losing weight, or just not gaining weight for more than one month, the protocol for reversing this is to:

• Lower the dose of stimulant.
• If that does not work, switch stimulant molecules
• If this is ineffective, use the lowest dose of a gentle antihistamine that is FDA-approved for children 3 years of age and older. While this is an off-label use, it often helps to maintain a very beneficial ADHD treatment until the child becomes tolerant of the medication. Antihistamines like cyproheptadine, for example, return appetite to previous levels for about six hours. They are usually taken 30 minutes before lunch and dinner.

Fear #4: What if a stimulant worsens my child’s anxiety?

ADHD shares a high comorbidity with anxiety disorder. Researchers conducted a meta-analysis of 23 studies of children diagnosed with anxiety who had started on ADHD stimulants and found that anxiety decreased significantly in almost all cases.³

Arm yourself with knowledge. Read about the findings from research studies that have investigated ADHD medication. Then you can make a rational, informed decision about what is best for your child and/or yourself.

ADHD and Stimulants: Next Steps

• Free Download: Reader Scorecard of ADHD Treatments
• Read: Treating a Child with ADHD Medication Diminishes His Future Risk of Substance Abuse
• Read: ADHD Medication Side Effects No One Should Tolerate

William W. Dodson, M.D., is a board-certified adult psychiatrist. He was named a Life Fellow of the American Psychiatric Association in 2012 in recognition of his contributions to the field of adult ADHD.

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#CommissionsEarned As an Amazon Associate, ADDitude earns a commission from qualifying purchases made by ADDitude readers on the affiliate links we share. However, all products linked in the ADDitude Store have been independently selected by our editors and/or recommended by our readers. Prices are accurate and items in stock as of time of publication.

Sources

¹ Barkley, R. A., & Fischer, M. (2019). Hyperactive child syndrome and estimated life expectancy at young adult follow-up: the role of ADHD persistence and other potential predictors. Journal of Attention Disorders, 23(9), 907–923. https://doi.org/10.1177/1087054718816164

² Schepis, T. S., Werner, K. S., Figueroa, O., McCabe, V. V., Schulenberg, J. E., Veliz, P. T., Wilens, T. E., & McCabe, S. E. (2023). Type of medication therapy for ADHD and stimulant misuse during adolescence: a cross-sectional multi-cohort national study. EClinicalMedicine, 58, 101902. https://doi.org/10.1016/j.eclinm.2023.101902

³ Coughlin, C. G., Cohen, S. C., Mulqueen, J. M., Ferracioli-Oda, E., Stuckelman, Z. D., & Bloch, M. H. (2015). Meta-Analysis: Reduced risk of anxiety with psychostimulant treatment in children with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 25(8), 611–617. https://doi.org/10.1089/cap.2015.0075

Teens who take prescription stimulants to manage their diagnosed ADHD face no elevated risk for later prescription drug misuse (PDM), according to a study published in Psychiatry Services.¹

Further, young adults with ADHD who took stimulants as teens are less likely to misuse stimulants compared with same-age peers who did not receive stimulant therapy. The strongest predictor of prescription stimulant misuse in young adulthood? Prescription drug misuse in adolescence.

The multi-cohort, U.S. national longitudinal study included 11,066 participants, ages 17 or 18, who completed questionnaires every two years until the age of 24. The questionnaires asked about the number of times participants used a prescription drug (benzodiazepine, opioid, or stimulant) without a doctor’s order.

Substance Use Disorder Rates Lower for Medicated Youth

This study marks the newest exploration in a body of research on the relationship between stimulant use and substance use in people with ADHD, conducted by a team that includes Timothy E. Wilens, M.D., Chief of Child and Adolescent Psychiatry, and Director of the Center for Addiction Medicine at the Massachusetts General Hospital.

“People with childhood ADHD are nearly twice as likely to develop a substance use disorder as are individuals who don’t have childhood ADHD,” ² explained Wilens in the ADDitude article “Treating a Child with ADHD Medication Diminishes His Future Risk of Substance Abuse.” “However, the risk of substance abuse decreases substantially when patients are treated with stimulant medication – even though it is considered a controlled substance. ADHD patients treated with stimulants experience a 60% reduction in substance abuse disorders compared to those who were not treated.” ³

In fact, Wilens added, the longer the child is treated for ADHD, the more robust the protective effect: Research suggests a 10% reduction in risk for substance use disorders for every year of ADHD treatment.⁴

The fact that stimulants decrease the risk of later substance abuse for youth with ADHD comes as a surprise to many parents. A common misconception that makes caregivers hesitate to medicate children for ADHD is the worry that stimulants will pave the way for addiction later on.

“I was worried that medications whose names sound like illegal drugs could lead to addiction,” explained a reader in a response to ADDitude’s 2023 treatment survey. “I wish I had known that ADHD medication helps prevent addictions to dangerous substances for people with ADHD.”

“The fact that unmedicated kids are much more likely to develop addiction was an important factor for us to consider in our decision to medicate our six-year-old,” wrote another ADDitude reader. “We assumed it would be the opposite: introduce them to meds now and they’d be looking for meds later — but understanding how the meds work to support him, it makes so much sense.”

Sources

¹ McCabe, Sean & Schulenberg, John & Wilens, Timothy & Schepis, Ty & Werner, Kennedy & McCabe, Vita & Veliz, Philip. (2024). Attention-Deficit Hyperactivity Disorder Stimulant Therapy and Prescription Drug Misuse During Transition to Young Adulthood. Psychiatric services (Washington, D.C.). 75. appips20230418. 10.1176/appi.ps.20230418.

² Charach et al. “Childhood Attention-Deficit/Hyperactivity Disorder and Future Substance Use Disroders: Comparative Meta-Analyses.” Journal of the American Academy of Child & Adolescent Psychiatry. 2011; 50(1): 9-21. doi: 10.1016/j.jaac.2010.09.019

³ Chang Z et al. “Stimulant ADHD medication and risk for substance abuse.” J Child Psychol Psychiatry. 2014; 55(8):878-85. doi: ^{10.1111/jcpp.12164}

⁴ McCabe SE, et al. “Age of Onset, Duration, and Type of Medication Therapy for Attention-Deficit/Hyperactivity Disorder (ADHD) and Substance Use During Adolescence: A Multi-Cohort National Study.” J Am Acad Child Adolesc Psychiatry. 2016; 55(6):479-486: doi: ^{10.1016/j.jaac.2016.03.011}

Non-stimulant medication is nearly as effective as stimulant medication at improving executive function in children, adolescents, and adults with ADHD, according to a systematic review and meta-analysis published in May by Neuroscience & Biobehavioral Reviews.¹

Long-term use of stimulant and non-stimulant medications had a similar positive effect on cognition, compared to placebo, for people with ADHD. Although the treatment effect sizes varied slightly in magnitude, a meta-regression analysis found no significant differences in the overall impact on cognition between each type of ADHD drug.

Methylphenidate (stimulant) and atomoxetine (non-stimulant) were the only two medications with multiple studies meeting inclusion criteria for this analysis. Improvements were measured based on four main cognitive domains related to ADHD: attention, inhibition, processing speed, and working memory.

Both methylphenidate and atomoxetine were most effective at improving attention and least effective at improving reaction time. Children and adolescents experienced more improvement than adults in reaction time and attention, whereas the effect size for inhibition was greater in adults, although these findings were not statistically significant.

Stimulants Vs. Non-Stimulants & Their Impact on Executive Function

Methylphenidate is the most common stimulant medication prescribed for the treatment of ADHD, followed by amphetamine, according to data cited by the study authors.² Stimulants work for 70% to 80% of children, adolescents, and adults with ADHD, and are typically recommended as a first-line treatment.³ Common brand names include:

• Methylphenidate: Concerta, Jornay PM, Ritalin, and others
• Amphetamine: Adderall, Dexedrine, Desoxyn, Xelstrym, and others

Non-stimulants generally have lower success rates than stimulants, but they are often a better choice for patients who respond poorly to amphetamine or methylphenidate. Atomoxetine is the most common non-stimulant, followed by guanfacine, clonidine, and viloxazine.⁴ Common brand names include:

• Atomoxetine: Strattera
• Guanfacine: Intuniv
• Clonidine: Kapvay
• Viloxazine: Qelbree

In addition to measuring behavioral symptoms — mainly short attention span, hyperactivity, and impulsivity — the present study highlights the potential for stimulants and non-stimulants to improve executive functioning, too.

“It has been shown that improvements in clinical symptoms are independent of improvements in cognitive functions, with clinical improvements not necessarily improving cognition,” wrote Ferdous Isfandnia, the study’s lead author. “It is hence reassuring to show with meta-analytic findings that both stimulant and non-stimulant medications for ADHD not only improve ADHD symptoms but also key cognitive functions that are typically impaired in ADHD.”

Methylphenidate and atomoxetine improve not only ADHD symptoms but also key cognitive functions that impact academic and occupational outcomes, wrote the study’s authors. A person with ADHD may struggle with tasks that involve organizing, planning, managing time, making decisions, and self-motivating. These deficits overlap with ADHD symptoms and contribute to issues at school, work, and home.

Non-stimulants like atomoxetine may be an effective alternative for some patients with ADHD navigating a nationwide stimulant drug shortage, as reported by the CDC and ADDitude. And they can be combined with stimulants, often at lower doses of each, to increase effectiveness, according to psychiatrist Timothy Wilens, M.D.*

“One of the things we found [in our paper] is that stimulants can help, but they often are not sufficient to manage all executive functioning,” Wilens said in an ADDitude webinar on combination therapy to treat complex ADHD. “We’re starting to see that some of the non-stimulants, like Strattera (atomoxetine) and Qelbree (viloxazine), seem to help. When you mix non-stimulants with stimulants, you can get impact.”

Cognitive behavioral therapy can also help manage cognitive symptoms. “These are largely medicated kids… who are still struggling with executive functioning, which is a very common scenario,” Wilens said. “The response rates for individuals by self-report or parent report were between 50% and 60%. So, pretty good outcomes for kids who had stable medicine regimens but still had a lot of cognitive executive functioning.”

Limitations and Future Research

This is the first meta-analysis to show that atomoxetine significantly improves cognitive functions relevant to ADHD, and to demonstrate that these improvements are comparable to methylphenidate. It’s also the first to specifically focus on the chronic use of ADHD medication. The study extended previous findings on the acute benefits of methylphenidate to long-term use.

A total of 28 studies were included: 20 on stimulant medication and 8 on non-stimulant medication. Most participants were male; consequently, these findings may not apply to the full ADHD population. “Chronic” or “long-term” use referred to anywhere from one to eight weeks. Future studies should consider going beyond eight weeks and include additional medications.

“The findings of our meta-analysis of positive effects of chronic administration of methylphenidate and atomoxetine on cognition are encouraging,” wrote the study authors, “as they may likely have an impact on real-life achievements such as school and academic performance in ADHD, as well as occupational performance and overall quality of life.”

*Always consult your healthcare provider before making changes to your treatment plan.

Sources

¹Isfandnia, F., Masri, S.E., Radua, J., & Rubia, K. (2024) The effects of chronic administration of stimulant and non-stimulant medications on executive functions in ADHD: A systematic review and meta-analysis. Neuroscience & Biobehavioral Reviews, 162. https://doi.org/10.1016/j.neubiorev.2024.105703.

² Faraone, S.V. (2018). The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neuroscience & Biobehavioral Reviews, 87, 255-270. https://doi.org/10.1016/j.neubiorev.2018.02.001.

³ Advokat, C., & Scheithauer, M. (2013). Attention-deficit hyperactivity disorder (ADHD) stimulant medications as cognitive enhancers. Frontiers in neuroscience, 7, 82. https://doi.org/10.3389/fnins.2013.00082

⁴ Groom, M.J. & Cortese, S. (2022). Current Pharmacological Treatments for ADHD. In: Stanford, S.C. &  Sciberras, E. (eds) New Discoveries in the Behavioral Neuroscience of Attention-Deficit Hyperactivity Disorder. Springer, Cham, 57, 19-50. https://doi.org/10.1007/7854_2022_330

Earlier this month, the Justice Department charged two top officers at the telehealth company Done Global with allegedly distributing Adderall and other stimulants for ADHD to patients who officials said did not merit a proper diagnosis. While health officials warned that the “disruption” to Done could affect as many as 50,000 adult patients¹, many of whom were already impacted by the ongoing ADHD medication shortage, this criminal action highlights another important issue: the limited access to clinical care for people with ADHD in the United States.

“When a company such as Done is held legally responsible and their policies are investigated, patients under clinicians’ care may lose their prescriber, leaving them abandoned without medical care,” says David Goodman, M.D., an assistant professor in psychiatry and behavioral sciences at the Johns Hopkins School of Medicine.

“The immediate need for medication is not easily resolved because changing providers typically involves a delay. Without effective medication, patients’ daily performance is compromised and may lead to conflicts at home or reduced work productivity,” Goodman says. “The negative consequences mount the longer they are off their medication.”

Rise and Fall of ADHD Telehealth

Done and other ADHD telehealth services surged in popularity during the COVID pandemic as Americans in lockdown were unable to schedule in-person doctor visits. At the same time, the Drug Enforcement Administration (DEA) loosened telemedicine rules regulating the prescription and distribution of controlled substances, including stimulants to treat ADHD.

“Done came out of real patient pain points, including access and wait times” for clinical care, says Jacob Behrens, M.D., CEO of Envision ADHD Clinic. “They expanded as they did for a number of reasons, including how poorly our health care system met the needs of this particular population. This issue is and has been real since well before the pandemic.”

Of the 30,000 to 50,000 patients who used Done and may be seeking new providers, Behrens said: “I can’t begin to imagine how the existing health care system will absorb this population. I’m just hoping that we can use this as an educational opportunity for a deeper dive/postmortem analysis of in what ways did this improve patient care and where did it go wrong?”

Maggie Sibley, Ph.D., a psychologist, researcher, and author, suggested that the Done investigation into fraudulent stimulant prescription practices might actually help alleviate the stimulant shortage for patients with ADHD.

“If many Done clients were filling Adderall prescriptions for non-medical reasons, then presumably they were taking medications that should have gone to people with ADHD,” she says. “Eliminating the non-legitimate use of stimulants might hopefully help with the demand side of the stimulant shortage. People will be able to get their medications more easily because they are reserved for people who truly have ADHD.”

ADHD Treatment Alternatives

Greg Mattingly, M.D., an associate clinical professor at Washington University School of Medicine, says he is hopeful that improved ADHD awareness and education, overall, will mean that patients ask their providers about new medications like Xelstrym, Jornay PM, and Azstarys, which are not experiencing the shortfalls that have dogged Adderall and Vyvanse. Patients who understand the full spectrum of ADHD treatment options may be more likely to access care during the ongoing stimulant shortage.

“The rising number of prescriptions during the past several years² has caught the DEA’s attention,” says Ann Childress, past president of the American Professional Society of ADHD and Related Disorders (APSARD). The DEA sets quotas for the production of controlled substances in the United States and is widely criticized for failing to allow enough production of stimulant medication to keep pace with new diagnoses.

“We are still dealing with a stimulant shortage, and I am still having to switch patients’ medications because their regular medication is not available,” Childress says. “Most clinicians that I speak with are having the same difficulties. Several medications that are not controlled substances are approved for the treatment of ADHD by the FDA. Patients may want to discuss these medications with their providers.”

Goodman advised that some hospital pharmacies may fill prescriptions for hard-to-find stimulant medications if those stimulants are ordered by an affiliated provider. He suggested that patients inquire with their providers about this option, as hospital pharmacies may experience less patient demand than neighborhood or chain pharmacies like CVS or Walgreens.

“Hospitals that have public community pharmacies can typically fill the same prescriptions that any other community pharmacy can fill,” says Aretha L. Hankinson, J.D., director of media relations for the American Society of Health-System Pharmacists. “They generally also experience the same allocations and shortages as other community pharmacies.”

Sources

¹ CDC. Disrupted Access to Prescription Stimulant Medications Could Increase Risk of Injury and Overdose. June 13, 2024. https://emergency.cdc.gov/han/2024/han00510.asp

² Danielson ML, Bohm MK, Newsome K, et al. Trends in Stimulant Prescription Fills Among Commercially Insured Children and Adults — United States, 2016–2021. MMWR Morb Mortal Wkly Rep 2023;72:327–332. DOI: http://dx.doi.org/10.15585/mmwr.mm7213a1

The ADHD medication shortage just got worse.

That’s according to the Centers for Disease Control and Prevention (CDC), which warned of likely ADHD treatment disruptions for thousands of Americans after two executives from Done, the telehealth provider, were arrested last week for alleged health care fraud. The CDC estimates that up to 50,000 patients who rely on Done or similar subscription-based telehealth platforms for ADHD medication may be impacted, plunging into crisis a system already massively strained by a two-year drug shortage.

The Department of Justice accuses Done of conspiring to illegally distribute Adderall and other stimulants for financial gain. It claims that Done pressured employees to prescribe the drugs to users even if they did not meet diagnostic criteria for ADHD and discouraged prescribers from following up with users after initial consultations, among other practices that allegedly allowed for “easy access” to stimulants.

In a statement, Done rejected the DOJ’s accusations and claimed it would continue to operate and work to ensure that its patients do not lose access to mental health care. “During these current proceedings, Done continues normal operations and is doing everything we can to ensure stable care for our patients,” reads part of the statement.

The CDC’s advisory warned of the far-reaching risks of untreated ADHD — risks that ADDitude readers know too well, especially amid ongoing shortages. From frustration over inadequate supplies of much-needed treatment (and hopelessness over government agencies’ failure to enact meaningful relief) to hopes that better regulation of ADHD medication and care may be forthcoming, reader reactions* to the telehealth indictment and its compounding effects on the ADHD medication shortage are varied.

“This is absolutely going to make our lives even harder. I have an AuDHD child. I have to ration her medication, which means I have to decide which days she’ll spend in a heap of despair and anguish, and which days she can participate in her childhood. Today she cannot participate in her childhood because next week is swim lessons and camp. We will run out of medicine if we don’t skip today.” —@laurapeles

[Read: How to Weather the Persistent Adderall Shortage]

“This is super frustrating. They make us jump through hoops every other day to get our meds when we literally have a hoop-jumping disability. But Done is a scam. I hope this facilitates the creation of better telehealth ADHD treatment in the future.” —@danimarie1029

“The DEA failed to act during the opioid crisis, so they’re manufacturing a stimulant crisis so they can get a win. They’ve been systematically fining and shutting down pharma companies who manufacture stimulants and literally creating this shortage. People with ADHD are not criminals but we are being treated that way because the DEA has lost the War on Drugs and sees us as an easy victim to use to make themselves look like the heroes. It’s gross and sad and, so far as I can tell, they will not be held to account. Meanwhile our lives and our kids’ lives are in shambles because it’s nearly impossible to get the medications we need to keep up with the rest of society. The inequity is staggering.” —@wordsmith610

“I know it’s frustrating, but stimulant medication needs to be better regulated for those of us that need it. It will help break the stigma surrounding ADHD medication. I have to see my doctor once a month to get my meds and med management check-ins. Everyone should have to do the same, at least at first.” —@homiekates

“We deal with [refilling medication] twice per month in our family. As someone who needs [ADHD medication] myself to get my frontal lobe to function more efficiently, this could not be a more arduous task. I’m always the first to roll my eyes when people in comments jump to conspiracies on an issue, but I don’t buy the ‘dishonest practitioner’ scapegoat.” —@thatmarvelmom

[Read: “Stop Treating Us Like We’re Addicts!”]

“I am not surprised, but I am thrilled this company is facing up to its shady practices. I used them (but do qualify) and the entire experience was an absolute mess. I canceled immediately because it was so horrid. I am not happy about what this might mean for refills for my son (or myself) and having to physically see a doctor every three to six months now.” —@laramccask

“This is infuriating. It only makes things harder for those of us with actual diagnosed ADHD to get the meds we need that save our lives.” —@bluestategirl

“It worries me a lot as my husband and I both depend on telehealth for our meds. We each see our psychiatrist monthly on Zoom for a good 30 to 45 minutes to discuss how we are doing and reacting to the meds we are on. My doctor is two hours away from me and my executive functioning difficulties would mean I’d never manage to go in anything close to monthly.” —@jennifernishizaki

“Those of us with REAL ADHD are suffering due to a large group of people with no real diagnosis who are getting scripts for fun from a random doctor who has not performed adequate testing.” —@okram82

“This makes me so worried! There are already so many hoops for those of us with an actual diagnosis. It’s infuriating that people like this and neurotypicals make it even harder for us to get medication to function. It’s even more frustrating because medication helps but certainly doesn’t ‘cure’ us like people think. I have a baby and need to function for him and us.” —@jacquelinedufour872

“It’s crazy to me that this is allowed to happen. ADHD is a disability and medication is a disability aid, no different than someone needing glasses to see or a cane to walk. The world constantly shits on the disabled.” —@alexandrahahnfeld

“I haven’t been able to have my medication since January. I have no executive functioning and when I finally do make myself do something I get extremely overwhelmed bouncing from thing to thing. People who don’t need these medications to actually function (e.g., cook, clean, bathe, work a job to survive) should not be taking them from those of us who do.” —@wnpersson

Done ADHD Medication Shortage: Next Steps

• Join the Conversation on Instagram
• Investigation: The Tattered Promise of ADHD Telehealth
• On the ADHD Drug Shortage: “This Cannot Be the Price We Pay to Function.”
• Opinion: “The DEA’s Manufactured Crisis”
• Call to Action! Speak Up to End the ADHD Drug Shortage
• Resource Center: Adderall Shortage

*comments edited for brevity and clarity

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What’s behind this? And what else can AuDHD individuals expect when taking ADHD medication?”

Certainly, stimulant medication can lower the volume on ADHD symptoms that might have once overshadowed autistic traits and behaviors, thus appearing to “unmask” autism. Enhanced focus brought on by stimulant medication can also increase awareness of one’s autistic traits, which may have gone mostly unnoticed before.

But stimulant medication may impact the expression of autistic traits in other ways. A common side effect of ADHD medication, for one, is anxiety. In the context of autism, this side effect can enforce autistic traits like a need for control, rigid thinking, and perseverative thoughts — traits rooted in anxiety that are present in almost all people on the spectrum.

In addition, while stimulant medications increase focus, this can go one of two ways. Ideally, the stimulant will help individuals focus on what they need to and want to focus on. Sometimes it can go the other direction, where stimulants can lead to hyperfocusing on distractions and getting stuck on mental processes. While this can happen to anyone who takes a stimulant, it’s not an uncommon side effect among autistic individuals who are already prone to rigid thinking and perseveration.

[Take This Self-Test: Signs of Autism Spectrum Disorder]

Stimulant medications also can increase heart rate and blood pressure. People on the spectrum may notice even small changes in heart rate and blood pressure, given heightened sensory sensitivities.

Are AuDHD Individuals More Sensitive to Stimulants?

In general, many autistic individuals tend to be more sensitive to medications and have a difficult time tolerating them. Between the two classes of stimulant medications and other non-stimulant medications, many treatment options exist for those with ADHD and autism. I have found that patients who are sensitive to medications do better on small doses of different medications rather than the traditional route of increasing each medication as far as can be tolerated. For all cases, we try to use the minimal amount needed.

Alpha agonists (such as guanfacine or clonidine) are a class of medication used to treat hyperactivity and impulsivity in ADHD in both children and adults. These medications tend to work well for many of my patients with ADHD and autism with a lower risk of side effects compared to stimulant medications. For example, I often prescribe guanfacine to help with restlessness and racing thoughts rooted in ADHD, as the alpha agonists may be less likely to increase rigidity and related traits rooted in autism. For some patients with the common trifecta of ADHD, autism, and anxiety disorder, using an alpha agonist or SSRI to reduce anxiety puts them in a better position to tolerate a stimulant for ADHD symptom control.

All patients, but especially those with ADHD and autism, should know what to expect when they start a medication. Patients should feel empowered to ask specifically what side effects to expect with these medications and how long the side effects may last, along with information about when to ask for help and/or stop the medication. In some cases, it’s a matter of tolerating side effects for a few weeks until the individual adjusts to the medication. Without this information, individuals who experience side effects may immediately assume that medication isn’t for them, when medication may be the key to improving quality of life with some patience.

[Get This Free Special Report: Scorecard of ADHD Treatments]

Beyond medication, other supports are available for managing co-occurring ADHD and autism, from therapy to skills-training. Additionally, many of my AuDHD patients say executive function coaching has made day-to-day living much smoother. Ultimately, treating AuDHD patients requires a multifaceted approach that needs to be individualized to each person and their other co-occurring diagnoses.

Autism and ADHD: Next Steps

• Free Download: Autism Evaluation Checklist
• Read: Medication Effectively Treats ADHD Symptoms in Adults with Comorbid Autism
• Read: “A Living Contradiction” Stories of the AuDHD Experience

Veena Ahuja, M.D., is a psychiatrist and the owner of Balanced Innovative Care located in Columbus, Ohio.

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What I found in my research was confusing. Assessing whether a medication was effectively treating ADHD seemed heavily reliant on subjective reporting. How was I to reliably tell if my child’s ADHD medication and dose were really working as well as they should?

I was frustrated and determined to get clear results – and then I had a lightbulb moment.

The Truth Before Our Eyes

One day, I was reading with my kid. I watched as their eyes darted all over the page, the focus slipping away right in front of me. This must happen to so many people with ADHD when they try to read, I thought.

That’s when it hit me: When we read, our eyes follow a specific pattern. Unless we have ADHD, and then our wandering minds might lead to wandering eyes, making our reading patterns different and more erratic.

[Get This Free Download: How Do We Know the Medication Is Working?]

Eye movement is key; tracking it could reveal patterns and lead to a methodology for ultimately measuring focus. I brought the idea to my sister, an AI and bioinformatics expert. Together, we began to use AI to analyze reading processes and eye-movement patterns. We found that by tracking these patterns, we could develop a tool that would provide a clear, data-driven picture of how ADHD medication affects concentration and impulsivity, thus, a way to measure treatment efficacy.

Turning a Novel Idea Into Reality

Enter Ravid, my rollerblading buddy who also has ADHD and expertise in digital health product development. The three of us made this wild idea a reality. While Ravid and my sister built the product, I reached out to clinicians.

I learned in those conversations that there was no tool available that could objectively track medication efficacy for a patient outside of the clinic. Clinicians and researchers loved our approach. Reading is universal but complex enough to capture different aspects of ADHD, and eye tracking can reveal both concentration and impulse control levels.

And that’s how iFocus was born. You can log in to our site from a webcam-enabled computer and read a paragraph with and without your meds. Our tool will track your eye movement through your webcam as you read and establish a score representing your progress compared to your baseline.

[Read This Special Report: ADHD Treatments Scorecard from Readers]

Each session only takes a few minutes, but the impact, we think, can be life changing.

Putting People in Charge of Their ADHD Treatment

Recently, my kid started a new medication, and we used iFocus to find the right dose. The experience was completely different. They tested themselves, reported how they felt, and we had meaningful discussions about the results.

The dose where my child felt best was lower than I anticipated, but both my child’s report and iFocus results confirmed that the dose was working. This is just one example of how iFocus empowers people with ADHD to take control of their treatment journey.

ADHD Medication Efficacy: Next Steps

• Read: How Can I Tell If the ADHD Medication is Working?
• Read: ADHD Medications Rarely Work Perfectly on the First Try
• Read: Stimulant, Non-Stimulant, or Both? Combination Therapy for ADHD

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In other words, it’s critical for college students and others who recently moved out on their own to develop reliable medication management routines without parental scaffolding — and to advocate for their own health care needs at the doctor’s office.

[Free Resource: 2024 Scorecard of ADHD Treatments]

Here is the advice I give to my young adult patients:

• Incorporate medication administration into your daily routine. Use alarms or reminders on your phone, or associate medication with specific daily activities (e.g., breakfast or brushing teeth). Use a pill organizer to keep track of doses.
• Understand the expected effects and potential side effects of ADHD medication, and the likelihood that ADHD symptoms will return if doses are skipped. Also know that ADHD medication reduces the risk of substance use and improves productivity at work and in school.
• With your provider, brainstorm ways to adjust your routine to better support medication maintenance. Discuss different medication options, such as long-acting versus short-acting formulations.
• Regularly monitor medication effectiveness and side effects. Keep track of changes in symptoms or adverse reactions. Talk to your doctor about these and any other challenges with your medication regimen, concerns about mixing your ADHD medication with other medications or substances, difficulties adhering to the prescribed schedule, or struggles with getting timely refills from your pharmacy.
• If you experience significant side effects, worsening symptoms, or recognize a change or deterioration in your work performance, relationships, sleep, exercise routines, task management, or overall executive functioning skills, it’s important to tell your health care provider.

ADHD Medication Management: Next Steps

• Download: Get Control of Your Life and Schedule
• Q&A: ADHD Medication — Side Effects, Dosages, Precautions & More
• Read: How to Treat a Teen Self-Medicating ADHD

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The ongoing shortages of generic ADHD medications and chemotherapy drugs are addressed in new draft legislative proposal released on May 3 by Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon), who said the proposed legislation would “tear down regulatory barriers that are preventing families from accessing critical drugs like those needed to combat ADHD.”

The draft legislation was announced on the same day the American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP), and Children’s Hospital Association (CHA) sent a letter to the U.S. Department of Health and Human Services and Drug Enforcement Administration expressing their continued concern about the ongoing stimulant medication shortages.

“Families that rely on generic stimulant medications have been disproportionately affected by the ongoing stimulant shortages,” the letter said. “This situation only exacerbates existing health disparities among economically disadvantaged families who are enrolled in Medicaid and CHIP.”

The proposed legislation establishes a Medicare Drug Shortage Prevention and Mitigation Program, wherein hospitals, healthcare providers, group purchasing organizations, drug manufacturers, and others could earn payment incentives for improving their purchasing and contracting practices across the supply chain for generic drugs, including generic versions of ADHD medications such as Adderall and Vyvanse. The proposed legislation would also limit inflationary rebates under the Medicaid Drug Rebate Program (MDRP) for certain generic drugs susceptible to shortages.

“It is unacceptable that America is consistently running out of affordable and essential generic medicines,” Wyden said in a press release. “Once again, monopolistic middlemen have put market power and profit over families’ healthcare.”

Associations Urge Government to Address ADHD Medication Shortage

In their letter on ADHD medication shortages, the AAP, AACAP, and CHA call on the federal government to “convene all relevant stakeholders for a forum to discuss the impact these shortages are having on patients, families, and their providers and identify actionable solutions that will alleviate these shortages.”

“Pediatric providers, including child and adolescent psychiatrists, pediatricians, and children’s hospitals, along with the patients and families they serve, face an insurmountable struggle with stimulant medication shortages,” the letter said. “Untreated ADHD can contribute to worsening mental and behavioral health disorders, including mood and substance-use disorders, unintended injuries resulting from ADHD-related impulsivity and long-term impacts on relationships-building, educational achievement, and professional success. Parents and families may also be negatively impacted by the disruption that untreated ADHD can cause in the home, school, and work environments.”

According to the American Society of Health-System Pharmacists (ASHP), 323 medicines are currently in short supply, the highest number of ongoing and active drug shortages since the organization began tracking data in 2021.

ASHP reported that “new DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances (12% of all active shortages).” The Drug Enforcement Agency (DEA) classifies stimulant ADHD medications, such as Adderall and Vyvanse, as “Schedule I,” which indicates drugs with a high potential for abuse.

FTC, HHS Seeks Public Input on ADHD Medication Shortage

The Federal Trade Commission (FTC) and U.S. Department of Health and Human Services (HHS) are seeking public input to understand how the practices of pharmaceutical middlemen contribute to drug shortages and impact patients, hospitals, healthcare providers (including small healthcare providers and rural hospitals), pharmacies, generic manufacturers, and other suppliers.

Sixty-three percent of the more than 6,200 public comments already submitted mention ADHD.

The deadline to submit public comments is May 30, 2024. Add your testimony at Regulations.gov.

The public can also demand an end to the ADHD medication shortage by writing letters to representatives, the DEA, and the FDA using templates provided by ADDitude.