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

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/

EndeavorOTC is an over-the-counter digital therapeutic authorized by the Food and Drug Administration (FDA) for the treatment of adults 18 and older with primarily inattentive or combined-type ADHD. In the U.S., it is indicated to improve attention and functioning as measured by computer-based testing. It is available without a prescription.

EndeavorOTC is not intended to be used as a stand-alone therapeutic and is not a substitution for ADHD medication.

Developed by Akili Interactive, EndeavorOTC is the first FDA-authorized over-the-counter digital therapeutic treatment for adult ADHD. It uses the same proprietary technology as EndeavorRx, an FDA-approved digital therapeutic for the treatment of children ages 8 to 12 with primarily inattentive or combined-type ADHD.

EndeavorOTC is available in the U.S. in the Apple App Store for iOS and the Google Play Store for Android mobile devices.

How Does EndeavorOTC Work?

Through its immersive video game experience, EndeavorOTC presents specific sensory stimuli and simultaneous motor challenges designed to alter pathways in the brain related to focus.

Adults typically interact with EndeavorOTC on mobile devices for 25 minutes daily, five days a week.

The EndeavorOTC games, which challenge players to simultaneously target and navigate through a series of obstacles, are designed to boost cognitive functions related to attention, focus, multitasking, and prioritization.

How Long Does EndeavorOTC Take to Work?

The clinical study supporting EndeavorOTC’s FDA clearance found that, after six weeks of EndeavorOTC use, 83% of participants saw clinical improvements in their ability to focus as measured by the TOVA attentional control score. Nearly three-quarters (72.5%) of participants reported some quality-of-life improvements as measured by the Adult ADHD Quality of Life Scale (AAQoL), and roughly half (45.8%) of adults met a prespecified threshold for clinically meaningful improvement.¹

What are the Side Effects of EndeavorOTC?

The clinical trial for EndeavorOTC reported no lasting or serious side effects. Of the 221 adults who received EndeavorOTC for six weeks in the trial, 11 (5%) reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%).¹

What Precautions are Associated with EndeavorOTC?

EndeavorRx may not be appropriate for patients with photosensitive epilepsy, color blindness, or physical limitations that stop a patient from comfortably holding a device.

To learn more about EndeavorOTC, visit EndeavorOTC.com.

What is EndeavorRX?

EndeavorRx, a version of EndeavorOTC designed for children ages 8 to 12 with ADHD, was approved by the FDA in June 2020. Through its immersive video game experience, EndeavorRx presents specific sensory stimuli and simultaneous motor challenges designed to target neural systems in the brain related to attentional control. Children interact with EndeavorRx on mobile devices and typically play for 25 minutes per day, five days a week. It is available by prescription from a licensed healthcare provider.

Learn more about EndeavorRx at www.endeavorrx.com/

Source

¹ Stamatis, C.A., Mercaldi, C., Kollins, S.H. (2023). A Single-Arm Pivotal Trial to Assess the Efficacy of Akl-T01, a Novel Digital Intervention for Attention, in Adults Diagnosed With ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. https://doi.org/10.1016/j.jaac.2023.09.510

One trademark of ADHD is low levels of dopamine, a neurotransmitter released by the brain that makes kids feel good and helps them focus. Increasing dopamine in the brain through medication is an effective treatment for ADHD. However, more than a year into a nationwide stimulant shortage, parents still struggle to fill prescriptions for their kids.

As the shortage stretches on, many caregivers are working to implement ADHD treatment tactics without medication. Here are some gut health strategies to consider.

Don’t Skip Meals

The way your child’s brain works is influenced by what they eat, and good nutrition is essential. Eating unhealthy, non-nutritious foods may contribute to inattention and problematic behaviors, while a diet with a variety of healthy foods nourishes the brain to pay attention and function optimally.

[Free Download: 5 Rules for an ADHD-Friendly Diet]

A study in Cell Metabolism found that dopamine release in the brain can occur at two different times: when food is swallowed and once the food reaches the stomach.¹ Skipping a meal robs the body of two potential releases of dopamine. If your child is not hungry, try to keep them on a regular meal schedule to help regulate opportunities for dopamine release. Healthy snacks help, too. A protein-rich diet, including fish, poultry, eggs, and legumes (e.g., beans, lentils, peas, etc.), can help increase dopamine levels.

Introduce Variety

Many kids with ADHD want to eat the same things every day, but doing so may mean they miss out on producing more of that feel-good hormone. Research has also found a strong connection between gut health and mental health. ² A healthy gut is best described as having a diverse microbiome, consisting of different types of microorganisms (bacteria, fungi, viruses, etc.) that coexist harmoniously in the digestive tract. Increasing the diversity of your child’s gut microbiome with a protein-rich diet, including fish, poultry, eggs, and legumes (e.g., beans, lentils, peas, etc.), ensures that dopamine can be adequately synthesized.

Introduce new foods slowly and in a variety of ways. For example, pick a vegetable your child usually eats and connect it to another vegetable or legume. So if your child eats raw carrots, pair them with a dip made of puréed red peppers or smooth refried beans. If your child prefers crunchy foods, make crunchy cooked veggies in the oven or air fryer. Experiment with spices, too. Offering your child small tastes (repeatedly) will build their acceptance of new foods. Kids are more likely to expand their taste and preference for new foods when given multiple chances to learn about and experience new food.

[Free Download: Meal-Planning Guide for ADHD Families]

Mindful Eating

Young children, especially those with ADHD, may be easily distracted during mealtimes. Make it a point to give your child a heads-up on what’s for dinner and when it will be served. Kids with ADHD do best when they know what to expect and follow a schedule. Then, turn off all electronic devices, including the TV, while eating to limit distractions. If possible, sit and eat together at the table. This lets your child know that during meals, it’s time to pause (even for a minute) and focus on eating. This is also a great time to share a moment with your child.

Gut Health Strategies for Treating ADHD: Next Steps

• Read: The ADHD Diet Plan: Healthy Foods and Supplements for Kids & Adults 
• Read: Food Therapy: The Right Nutrition for ADHD Symptoms
• Download: ADHD Brain Food: What to Eat, What to Avoid
• Watch: “What to Eat, What to Avoid: The ADHD Guide to Food and Nutrition for Children”

SUPPORT ADDITUDE
Thank you for reading ADDitude. To support our mission of providing ADHD education and support, please consider subscribing. Your readership and support help make our content and outreach possible. Thank you.

The opinions expressed in ADDitude Guest Blogs are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of ADDitude. Blogs are not reviewed by an ADDitude physician or any member of the ADDitude editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. Some of these opinions may contain information about treatments or uses of drug products that have not been approved by the U.S. Food and Drug Administration. ADDitude does not endorse any specific product, service or treatment.

Do not consider ADDitude Blogs as medical advice. Never delay or disregard seeking professional medical advice from your doctor or other qualified healthcare provider because of something you have read on ADDitude. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. ADDitude understands that reading individual, real-life experiences can be a helpful resource, but it is never a substitute for professional medical advice, diagnosis, or treatment from a qualified health care provider. If you think you may have a medical emergency, call your doctor or dial 911 immediately.

Sources

¹Thanarajah, S.E., Backes, H., DiFeliceantonio, A.G., Albus, K., Cremer, A.L., Hanssen, R., Lippert, R.N., Cornely, O.A., Small, D.M., Brüning, J.C., Tittgemeyer, M. (2018) Food Intake Recruits Orosensory and Post-ingestive Dopaminergic Circuits to Affect Eating Desire in Humans. Cell Metabolism. https://doi.org/10.1016/j.cmet.2018.12.006

²Chen, Y., Xu, J., Chen, Y. (2021). Regulation of Neurotransmitters by the Gut Microbiota and Effects on Cognition in Neurological Disorders. Nutrients. https://doi.org/10.3390/nu13062099

We often live in a state of distracted autopilot, not paying close attention to what we are hearing or doing in the moment. We get caught up in habit and reactivity, saying and responding as we typically do without intention.

But there are concrete implications to not seeing what’s actually going on as it happens. With mindfulness, in contrast, you do your imperfect best to give moment-to-moment, unbiased, compassionate awareness to your life.

Mindfulness aims to increase your happiness and ease — with or without ADHD. It takes persistence to reinforce new cognitive habits, but intentional change is possible if you choose to try.

Mindfulness Practice Reduces Stress

Stress perpetuates stress when you elect to do nothing about that pattern. Stressful thoughts change your emotional state and affect how your body feels, which, in turn, affects your thoughts and emotions. Reactivity reigns in fight-or-flight mode. It’s hard to think clearly. This cycle can feel endless.

[Get This Download: Make Mindfulness Work for You]

However, practicing mindfulness during stressful moments can yield important benefits. Feeling settled helps you manage the stress-producing disorder of ADHD. You think more flexibly and stick to your plans better. You break the stress cycle, which leads to easier ADHD care.

Simply said: Practice managing stress, and you will feel less stressed.

Mindfulness Practice Builds Emotional Resilience

Emotional reactivity, ranging from anger and tears to frustration and shutting down, is inherently part of ADHD; conversely, mindfulness builds emotional awareness. You give yourself permission for a few minutes to notice whatever is happening and not get caught up in it (e.g., “I’m angry but not acting on my anger for now.”). Through that process, you build patience with emotions (and anything else that triggers you).

Mindfulness is not passive. It’s about intention. For the rest of the day, there may be problems to solve or things to do. But for 10 to 15 minutes, you resolve to notice emotions and aim not to fall back on your typical reactions to them.

Simply said: Train yourself to notice emotions, and you’ll manage emotions more easily.

Mindfulness Practice Increases Self-Compassion

People with ADHD struggle mightily at times to accomplish what they know they need to do. That struggle can impact an individual’s self-image. Since your mindset relates to your resilience, this not only changes how you feel, but it can undermine ADHD care itself, which requires effort and persistence.

[“Do I Have ADHD?” Take the ADD Symptoms Test for Adults]

Self-compassion is inherently part of mindfulness practice. You try your best yet get distracted. How would you advise a young child? “It’s okay; just try again.” Reinforcing this habit within yourself matters. You cannot eliminate your inner critic (which may say something like, “I always screw up”), but you can learn to relate to it differently: “Thanks for the feedback. I’m doing my best.” It sounds strange at first, but this response becomes intuitive.

Simply said: You can learn to relate to yourself as kindly as you would support a close friend.

How to Practice Mindfulness

Set aside short-term expectations. It is called mindfulness practice for a reason. The fundamental starting point is just do it. The bottom line is that, as uncomfortable as it might seem at first, you can meditate. You’ll strengthen traits like awareness, responsiveness, and compassion, and more easily break ineffective cognitive habits. Keep in mind that it takes a while to change lifelong mental habits.

Set your best intention and see what happens next. Stay patient when you forget to practice. That’s all part of the experience. It might seem hard to stick with, but it is valuable, nevertheless.

Simply said: Anyone can practice mindfulness. Try it and see what happens for you.

How to Practice Mindfulness: Next Steps

• Download: The ADDitude Guide to Alternative ADHD Therapies
• Listen: “Mindfulness for Adults Living with ADHD” 
• Read: Keep Calm and Breath Om: 7 ADHD Relaxation Techniques

Mark Bertin, M.D., is a developmental pediatrician in Pleasantville, New York, and the author of How Children Thrive (#CommissionsEarned)and Mindful Parenting for ADHD(#CommissionsEarned). His website is developmentaldoctor.com.

#CommissionsEarned As an Amazon Associate, ADDitude earns a commission from qualifying purchases made by ADDitude readers on the affiliate links we share.

SUPPORT ADDITUDE
Thank you for reading ADDitude. To support our mission of providing ADHD education and support, please consider subscribing. Your readership and support help make our content and outreach possible. Thank you.

EndeavorRx is a digital therapeutic authorized by the Food and Drug Administration for the treatment of children ages 8 to 12 with primarily inattentive or combined-type ADHD. In the U.S., EndeavorRx is indicated to improve attention as measured by computer-based testing, and it is available by prescription from a licensed health care provider.

EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s ADHD medication.

Developed by Akili Interactive, EndeavorRx is the first game-based digital therapeutic device to receive marketing and prescription authorization by the FDA for any type of condition. It has also received Conformité Européenne (CE) Mark certification in Europe.

How Does EndeavorRx Work?

Through its immersive video game experience, EndeavorRx presents specific sensory stimuli and simultaneous motor challenges designed to target neural systems in the brain related to attentional control. Children interact with EndeavorRx on mobile devices, and they typically play for 25 minutes per day, 5 days a week.

The EndeavorRx games, which challenge players to multitask and ignore distractions, are designed to target areas of the brain tied to attention control.

How Long Does EndeavorRx Take to Work?

A randomized, controlled clinical study conducted by parent company Akili Interactive showed improvement, as measured by the Test of Variable Attention (TOVA), on at least one measure of objective attention within four weeks of beginning treatment with EndeavorRx.¹ Akili reports that a more recent trial demonstrated that 68% of parents reported improvements in ADHD-related impairments after two months of treatment.¹

What are the Side Effects of EndeavorRx?

In EndeavorRx trials, fewer than 10% of participants experienced treatment-related adverse events including frustration, headaches, dizziness, emotional reactions, nausea, and aggression. All such events were transient and did not carry lasting effects.¹

What Precautions are Associated with EndeavorRx?

EndeavorRx may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child’s healthcare provider.

Learn more about EndeavorRx at https://www.endeavorrx.com/

What is EndeavorOTC?

EndeavorOTC is a video game app clinically designed to treat symptoms of inattentive ADHD in adults. It was developed by Akili using the same proprietary technology behind EndeavorRx. According to Akili, adults who participated in a clinical trial studying the app showed improved focus and attention, and reported a better quality of life, including completing tasks on time, multitasking, and keeping track of personal items. EndeavorOTC is available without a prescription for adults 18 and older through the iOS Apple store and Google Play Store. Learn more about EndeavorOTC at https://www.endeavorotc.com/.

Sources

¹ Kollins, S. H., DeLoss, D. J., Cañadas, E., Lutz, J., Findling, R. L., Keefe, R. S. E., Epstein, J. N., Cutler, A. J., & Faraone, S. V. (2020). A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. The Lancet. Digital health, 2(4), e168–e178. https://doi.org/10.1016/S2589-7500(20)30017-0

² Kollins, S. H., Childress, A., Heusser, A. C., & Lutz, J. (2021). Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ digital medicine, 4(1), 58. https://doi.org/10.1038/s41746-021-00429-0

Xelstrym is a once-daily transdermal amphetamine patch used to treat ADHD in adults and children aged 6 and older. Xelstrym was approved by the FDA in March 2022 and can be used to increase attention and decrease impulsiveness and hyperactivity in people with ADHD. The patch comprises three layers: a printed backing, an acrylic adhesive matrix containing dextroamphetamine, and a release liner.

How Do You Use Xelstrym?

Xelstrym may be applied to the upper arm, upper back, hip, chest, or flank area. Patients should alternate between these placements each time a new Xelstrym patch is applied. Apply the patch two hours before the effects of the medication are needed and remove within nine hours. Do not use more than one patch in a 24-hour period.

Refer to the medication guide and full prescribing information, including the boxed warning, before taking Xelstrym. Patients or their caregivers should talk to a doctor to determine if Xelstrym is a good fit. The safety and effectiveness of Xelstrym for pediatric patients under 6 years of age is still unknown.

What Is the Typical Dosage for Xelstrym?

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 best response — that is, the lowest dosage at which you experience the greatest improvement in symptoms without side effects.

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

Patients should not substitute with other amphetamine products while using Xelstrym.

What’s the Difference Between Xelstrym and Daytrana?

Daytrana and Xelstrym are class II stimulants, and both are delivered via transdermal patches. Daytrana, an amphetamine-based patch, is available to children between the ages of 6 and 17 and is applied to the hip area. Xelstrym, a dextroamphetamine-based patch, may be prescribed to both adult and pediatric populations. Application sites include the hip, upper arm, upper back, chest, or flank area.

Adderall XR is an amphetamine/dextroamphetamine medication delivered via a once-daily, timed-release capsule.

What Are the Ingredients in Xelstrym?

Dextroamphetamine is the active ingredient used in Xelstrym. Inactive ingredients include acrylic adhesives, green ink, polyester/polyurethane backing, and polyester release liner. Xelstrym is manufactured by Noven Pharmaceuticals, Inc.

What Side Effects Are Associated with Xelstrym?

Among the most common side effects reported with Xelstrym are:

• trouble sleeping
• increased heart rate
• increased blood pressure
• irritability
• decreased appetite
• headache
• stomach pain
• nausea
• muscle twitching (tics)
• vomiting
• see the full list of possible side effects here

Serious heart-related problems may occur while taking Xelstrym, including sudden death, stroke, and heart attack in adults; or sudden death in children who have heart problems or heart defects. Increases in blood pressure and heart rate may also occur.

Patients may experience new or worsening psychiatric problems or bipolar illness, new psychotic symptoms, or new manic symptoms while taking Xelstrym. Any personal or family history of suicide, bipolar illness, depression, or other mental health problems should be disclosed.

Other serious side effects include:

• slowed growth in children, including height and weight
• circulation problems in fingers and toes, including Raynaud’s Phenomenon
• serotonin syndrome
• contact sensitization
• application site reactions, including pain, itching, burning feeling, redness, discomfort, or swelling at the application site.

Wait until you know how Xelstrym affects you before participating in potentially dangerous activities like driving or operating heavy machinery.

What Precautions Are Associated with Xelstrym?

Heart rate and blood pressure should be regularly monitored while taking Xelstrym. Patients with a personal or family history of high blood pressure, heart problems, or heart defects should share this with their HCP.

Dextroamphetamine is a federally controlled Class II substance. Abuse, physical dependence, or psychological dependence may occur. Talk to your provider about the risk of abuse prior to being treated with Xelstrym, including any history of abuse or dependence on alcohol, prescription medicines, or street drugs. When taking Xelstrym, monitor for signs of abuse and dependence.

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

Patients with severe renal impairment who take Xelstrym should not exceed a maximum dosage of 13.5mg, or 9mg for end stage renal disease.

What Interactions Are Associated with Xelstrym?

Do not use Xelstrym if you have a known sensitivity to amphetamines, or if you are taking a monoamine oxidase inhibitor (MAOI) or have within the past 14 days.

Tell your doctor if you are taking SSRIs, triptans, lithium, tramadol, buspirone, SNRIs, tricyclic antidepressants, fentanyl, tryptophan, or St. John’s Wort. A full list of current medicines, vitamins, and herbal supplements should be disclosed by the patient.

Patients may experience pain, redness, and other signs of discomfort around the Xelstrym application sites. Report any adverse reactions to a doctor.

This is not a complete list of all possible drug interactions. Refer to Xelstrym’s drug label information for consumers and health care professionals. Patients who are exposed to potentially dangerous levels of this medication should go to the nearest emergency room and/or call their doctor or a poison control center.

Sources

Noven Pharmaceuticals, LLC. (n.d.) Is it time to consider a patch to treat your ADHD? http://www.xelstrym.com

Noven Pharmaceuticals, Inc. (n.d.) Xelstrym. https://www.noven.com/xelstrym/

Daily Med. (2023, March 28). Label: Xelstrym. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0862f02a-72a8-41cc-8845-57cf4974bb6f&audience=consumer

NATURAL TREATMENT: What natural treatments are proven to benefit ADHD symptoms?

A: Some natural remedies may ease some symptoms. Others have little effect. Among the proven therapies are… | Keep reading on WebMD »

NUTRITION: What dietary changes could improve my ADHD symptoms?

A: There’s no clear scientific evidence that ADHD is caused by diet or nutritional problems. But certain foods may play at least some role in affecting symptoms… | Keep reading on WebMD »

SUPPLEMENTS: What vitamins or supplements could improve my ADHD symptoms?

A: Besides being good for heart health, omega-3 fatty acids improve symptoms of ADHD, including behavior, cognitive skills, and focus… | Keep reading on ADDitude »

CAFFEINE: Can caffeine improve my ADHD symptoms?

A: A few studies have looked at how caffeine can affect ADHD, but the results have been mixed. Caffeine is a stimulant, but… | Keep reading on WebMD »

DIETARY BALANCE: How can I better understand the way nutrition affects ADHD brain functioning?

A: Research indicates that healthy eating supports a healthy ADHD brain. At the same time, science tells us that ADHD symptoms significantly impede and impair individuals’ ability to make positive choices around food… | Keep reading on ADDitude »

BRAIN FOODS: What foods should I eat (and avoid) to improve my ADHD symptoms?

A: Carbs affect brain function and mood. The rate at which sugar from a particular food enters brain (and other body) cells is called the “glycemic index.” Foods with the best brain sugars include… | Keep reading on ADDitude »

FIRST-PERSON: “I Keep My ADHD Symptoms Under Control By…”

“Watching what I eat helps. I function better when I eat healthy foods like lean protein, veggies, and fruits instead of processed foods.” | Keep reading on ADDitude »

RELATED RESOURCES

FREE DOWNLOAD: ADHD Brain Food: What to Eat, What to Avoid

Research shows that protein promotes alertness in the brain. Carbohydrates do the opposite. And artificial colors and flavors are even worse. | Download now on ADDitude »

FREE DOWNLOAD: ADHD Vitamins and Supplements

This guide outlines ADHD-friendly vitamins and supplements — like iron, zinc, and magnesium — that may help common ADHD symptoms. | Download now on ADDitude »

8-Part Guide to ADHD Treatment in Adults, from WebMD x ADDitude:

DECISION 1: How should I approach my ADHD treatment plan?
DECISION 2: Should I treat my ADHD symptoms with medication?
DECISION 3: How can I address the side effects associated with ADHD medication use?
> DECISION 4: How should I integrate nutrition into my ADHD treatment plan?
DECISION 5: How should I integrate exercise & mindfulness into my ADHD treatment plan?
DECISION 6: What therapies should I integrate into my ADHD treatment plan?
DECISION 7: How and when should I adjust my ADHD treatment plan for optimal benefit?
DECISION 8: How should I adjust my ADHD treatment plan if I have comorbid conditions?

Monarch eTNS is a non-medication prescription device designed for overnight use in children with ADHD ages 7 to 12. The Monarch eTNS System is the first FDA-cleared device for ADHD with proven efficacy in alleviating ADHD symptoms, according to a small study.¹

How Does Monarch eTNS Work?

The Monarch eTNS (external Trigeminal Nerve Stimulation) System is an electronic device, about the size of a cell phone, that connects to a disposable patch placed on a child’s forehead at bedtime. Once turned on, the device sends low stimulating pulses to the trigeminal nerve through the patch overnight. The trigeminal nerve is the brain’s largest cranial nerve responsible for communicating sensations from the face to other parts of the nervous system — including brain areas involved in mood disorders, epilepsy, and attention.

Who Can Use Monarch eTNS?

Monarch eTNS is for patients ages 7 to 12 who are not currently taking prescription ADHD medication. The device should not be used by patients with an active implantable pacemaker or implantable neurostimulator, or in those with body-worn devices (e.g., insulin pumps).

What Studies Have Been Done on Monarch eTNS?

Two clinical trials compared the Monarch eTNS system’s efficacy in treating ADHD to a placebo device.

In 2014, 24 children with ADHD aged 7-14 years participated in an 8-week, open-label pilot feasibility study. After four weeks of nightly use, the Clinical Global Impression–Improvement (CGI-I) scale rated 64% of the study group as “improved” or “improved very much.” This trial showed a 47% decrease in the ADHD Rating Scale IV (ADHD-RS-IV) score and a responder rate of 71% on the Clinical Global Impressions Scale-Improvement (CGI-I) scale after eight weeks. Trial participants used the treatment as directed, side effects were minimal, and no child withdrew from the study due to adverse events, according to results published in Brain Stimulation.¹

A team of UCLA researchers published the results of the first double-blind, placebo-controlled trial examining the efficacy of the Monarch eTNS on ADHD in children in the Journal of the American Academy of Child and Adolescent Psychiatry in 2018. They concluded that more than half of the children (52%) who used the Monarch at bedtime for four weeks—under parent supervision—experienced significantly reduced impulsivity, hyperactivity, and inattention, as measured by clinician-administered ADHD rating scales compared to the placebo group (14%).

What Are the Side Effects of Monarch eTNS?

The most common side effects observed with eTNS included drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. No serious adverse events were associated with device use.

Where Can I Learn More About Monarch eTNS?

You can learn more about Monarch eTNS at https://www.monarch-etns.com/.

Sources

^{1</supMcGough, J.J., Loo, S.K., Sturm, A., et al. (2015). An Eight-Week, Open-Label Pilot Feasibility Study of Trigeminal Nerve Stimulation in Youth with Attention-Deficit/Hyperactivity Disorder. Brain Stimulation. 8:299-304. https://doi.org/10.1016/j.brs.2014.11.013}

^{2</supMcGough, J.J., Sturm, A., Cowen, J., et al. (2019). Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 58(4):403-411. https://doi.org/10.1016/j.brs.2014.11.013}

Up to two-thirds of children with attention deficit hyperactivity disorder (ADHD) have used complementary and alternative medicine (CAM) to address their symptoms, according to a new study published in the Journal of Attention Disorders.

Nutrition modifications; natural products, such as herbs, vitamins, and minerals; and mind-body practices like mindful meditation were the most-reported CAMs. The use of alternative therapies was higher in families where the caregiver preferred natural therapies for ADHD and believed CAMs could synergistically boost conventional medicine.¹

In addition, researchers found two predictive factors for alternative therapy use: parents’ education level (the more educated the parents, the more likely alternative therapies were used) and female gender.

“It seems that parents with higher education are open-minded,” the researchers wrote. “Additionally, they usually try Internet sources, books, and even magazines and other information sources to treat their children.”

The study found that more females opted for complementary and alternative medicine than males. “One of the most important reasons for the higher CAM use in patients of the female gender is the fact that they usually employ more health services than males,” researchers said.²

For the study, researchers reviewed The Web of Science Core Collection, PubMed, and Scopus databases from inception to February 10, 2022, for reports of complementary and alternative medicine usage by patients with ADHD. Data came from 12 original papers, which included a total of 4,447 patients, all younger than 18 years old.

To the researchers’ knowledge, this is the first systematic review to examine the prevalence, possible determinants, and type of alternative therapies used by patients with ADHD.

They recommended training healthcare providers on the most common CAM therapies and possible adverse effects or interactions with conventional medications. “They [healthcare providers] should have a deeper and more informed dialog about this matter with ADHD patients, which encourages them to disclose their CAM use,” researchers said.

This study had several limitations, such as only including articles published in English, and that most studies were from the U.S. and Australia.

Sources

¹Wu, J., Li, P., Luo, H., & Lu, Y. (2022). Complementary and Alternative Medicine Use by ADHD Patients: A Systematic Review. Journal of Attention Disorders. doi.org/10.1177/1087054722111155

²Lorber, J., Moore, L. J. (2002). Gender and the Social Construction of Illness. Rowman Altamira.

Azstarys is a once-daily central nervous system (CNS) stimulant ADHD medication approved for the treatment of ADHD symptoms in patients 6 years of age and older. Formerly referred to as KP415, Azstarys comprises serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Like all methylphenidate-containing products, Azstarys is a federally controlled substance (CII) because it can be abused or lead to dependence.

Azstarys Dosage

The optimal dosage of Azstarys varies by patient. For updated information about dosages, interactions, and precautions, see the Azstarys drug monograph on WebMD.

Azstarys can be taken with or without food. Patients may swallow capsules whole or open and sprinkle onto applesauce or add to water.

Azstarys: Side Effects

The most common side effects of Azstarys include:

• decreased appetite
• nausea or indigestion
• weight loss
• dizziness
• mood swings
• increased blood pressure
• trouble sleeping
• vomiting or stomach pain
• anxiety
• irritability
• increased heart rate

Azstarys and Heart Problems

If you or your child has heart problems, heart defects, high blood pressure, or a family history of these problems, your doctor should check you or your child before and during taking Azstarys; increases in blood pressure and heart rate may occur. Call your healthcare provider right away or go to the nearest hospital emergency room if you or your child experience chest pain, shortness of breath, or fainting while taking Azstarys.

Azstarys and Mental Illness

If you or your child has psychiatric problems, or a family history of suicide, bipolar illness, or depression, tell your doctor before starting Azstarys. New or worse behavior and thought problems may occur, as well as new psychotic or manic symptoms. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.

Azstarys and Circulation Problems

Talk to your doctor before starting Azstarys if you or your child has circulation problems in fingers and toes. Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red. Call your healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Azstarys.

Azstarys and Growth in Children

There has been some concern that stimulants may cause a slowing of growth in children and adolescents, however research findings are mixed. Some studies show no impact on growth at all,¹ while others find what is considered “negligible” slowing of growth.² If you find evidence of suppressed growth in your child, talk to your doctor about what steps might help.

Azstarys and Pregnancy

Let your doctor know if you or your child is pregnant or plan to become pregnant. It is not known if Azstarys may harm your unborn baby. Azstarys passes into breast milk – talk to your healthcare provider about the best way to feed your baby if you take Azstarys.

Azstarys: Associated Precautions

Do not take Azstarys if your or your child is allergic to any of the ingredients, including serdexmethylphenidate or methylphenidate. Azstarys should not be taken if you or your child is taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Azstarys: Associated Interactions

Those taking antihypertensive drugs in additional to Azstarys should have their blood pressure monitored. The use of Azstarys should be avoided on the day of surgery if halogenated anesthetics will be used.

Azstarys: Next Steps

• Free Download:A Parent’s Guide to ADHD Medications
• Free Download: Medication Monitoring Log
• Read: A Patient’s Primer on the Stimulant Medications Used to Treat ADHD
• Find: ADHD Specialists and Clinics Near You

Sources

¹Pediatrics (2014.) “ADHD, Stimulant Treatment, and Growth: A Longitudinal Study.” https://publications.aap.org/pediatrics/article-abstract/134/4/e935/77034/ADHD-Stimulant-Treatment-and-Growth-A-Longitudinal

²Journal of the American Academy of Child & Adolescent Psychiatry. (2019.) “Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder.” https://www.jaacap.org/article/S0890-8567(19)31443-1/fulltext

Qelbree (Generic Name: viloxazine) is a non-stimulant ADHD medication containing a serotonin norepinephrine modulating agent approved by the FDA to treat attention deficit hyperactivity disorder (ADHD or ADD) in adults and children over six years of age.

Its active ingredient, viloxazine hydrochloride, was previously marketed as an antidepressant in Europe. It is the first non-stimulant ADHD medication to receive FDA approval for use in children since Intuniv was approved in 2009.

The optimal dosage of Qelbree varies by patient. For updated information about dosages, interactions, and precautions, see the Qelbree drug monograph on WebMD.

Qelbree capsules can be swallowed whole or opened and sprinkled onto food. Do not cut, crush, or chew the capsules.

Qelbree Side Effects

Qelbree can increase diastolic blood pressure and heart rate. These measures should be assessed before to starting treatment, following increases in treatment, and periodically during treatment.

Other commonly observed side effects of Qelbree include:

• drowsiness or somnolence
• decreased appetite
• fatigue
• nausea
• vomiting
• trouble sleeping
• irritability

Qelbree and Increased Risk of Suicidal Thoughts

Qelbree may increase suicidal thoughts and actions in some patients, especially within the first few months of treatment or when the dose is changed. Closely monitor any new or sudden changes in mood or behavior, and call your doctor immediately if there are any new or sudden changes, or if there is development of suicidal thoughts or actions.

Qelbree and Mania or Hypomania in Patients with Bipolar Disorder

Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Before starting Qelbree, patients should be screened for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression.

Qelbree and Somnolence or Fatigue

Activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, should be avoided until the patient knows how they will be affected by Qelbree.

Qelbree Interactions

Patients that take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines, should not take Qelbree.

Qelbree is a strong CYP1A2 inhibitor. Coadministration with moderately sensitive CYP1A2 substrates, such as clozapine and pirfenidone, is not recommended. Qelbree is a weak inhibitor of CYP2D6 and CYP3A4, which increases exposure of those substrates, such as dextromethorphan and alfentanil, when coadministered with Qelbree.

How Does Qelbree Work for ADHD?

Data from two studies presented by Qelbree’s manufacturer, Supernus Pharmaceuticals, Inc., at Psych Congress 2023 showed improved efficacy in children aged six and older with ADHD when Qelbree was added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with the medication.¹

An eight-week, Phase IV, open-label study found that when added to existing psychostimulants, Qelbree demonstrated a favorable safety and tolerability profile and improvement in ADHD symptoms in pediatric patients (6-17 years), regardless of the timing of dosing. For the study, children (ages 6-11) and adolescents (ages 12-17) took psychostimulants at least five days a week in the morning. They received Qelbree once daily in the morning through week four and then switched to evening dosing through week eight; children received 100mg per day of Qelbree at week one and were optimized to 100-400mg per day, and adolescents received 200mg per day of Qelbree at week one and were optimized to 200-600mg per day.

Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant. At baseline (N=56), mean (standard deviation) ADHD-RS-5 and CGI-S scores were 37.2 (8.35) and 4.4 (0.56), respectively, and improved at week four (N=54) by -13.5 (9.7) and -0.9 (0.92), respectively, and at week eight (N=48) by -18.2 (9.99) and -1.4 (1.10), respectively. Reported adverse events of the combination therapy included headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%), and 3.6% of patients discontinued the combination treatment due to an AE.

The results from a long-term, open-label extension (OLE) trial of the double-blind pivotal Phase III study that led to the U.S. Food and Administration (FDA)-approval of Qelbree in adults with ADHD found that adult patients (N=159) saw improvement in ADHD symptoms and executive function with safety and tolerability similar to the initial trial.

For the study, adults received 200mg of Qelbree daily for one week, increased to 400mg, and optimized over twelve weeks up to 600mg per day (200-600mg per day). Patients in this open-label trial received Qelbree for 265 (254.9) days.

Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54). Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing an improvement in executive function of -12.9 (13.48). Reported AEs were consistent with those seen in the short-term pivotal adult trial. The most commonly occurring AEs with the use of Qelbree were insomnia (11.3%), nausea (9.4%), headache (5.7%), and fatigue (10.1%). AEs led to discontinuation in 17.6% of patients.

Qelbree: More Information on ADHD Medications

• Read: A Parent’s Guide to ADHD Medications
• Read: FDA Approves New Nonstimulant ADHD Medication from Supernus Pharmaceuticals
• Download: Take Charge of Your Child’s Medication
• Download: How Do We Know the Medication Is Working?
• Find: ADHD Specialists or Clinics Near You

Sources

¹“Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms.” Supernus Pharmaceuticals, Inc. (September 2023) https://ir.supernus.com/news-releases/news-release-details/supernus-announces-new-qelbreer-data-showing-improvement-adhd

“Supernus Announces FDA Approval of Qelbree (SPN-812) for the Treatment of ADHD.” Supernus Pharmaceuticals, Inc. (April 2021) https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreetm-spn-812-treatment-adhd

Qelbree label. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf

Qelbree. Non-Scheduled ADHD Treatment | Qelbree HCP

Children with ADHD experience out-sized benefits from music. The rhythm, melody, tempo, and lyrics of music may be harnessed to help them activate focus, boost organizational skills, incentivize desired behaviors, improve ADHD symptoms, and more.

Whether it’s Mozart or Metallica, music benefits kids with ADHD, even if they’re not musicians. Here, learn creative activities your family can incorporate into daily life that turn up the volume on music’s healing powers.

The Benefits of Music for Kids with ADHD

1. Music improves attention and focus.

The temporal and rhythmic properties of music are thought to modulate some symptoms of inattentiveness. Playing, or learning to play an instrument, can also help develop skills needed for sustaining attention, alternating attention, impulse control, and decision-making. One study found that children who studied a musical instrument showed better auditory connectivity in the brain, which is often diminished in ADHD brains.

Music lessons also increase your child’s ability to work in a noisy environment, which is useful for coping with distractions.

[Click to Read: Music That Focuses the Brain]

2. Music reinforces memory.

Attaching information to lyrics and melody helps children — with and without ADHD — remember important items. Try teaching phone numbers, addresses, chores, and procedures (like washing hands or tying shoes) to the tune of your child’s favorite songs.

3. Music acts as a study aid.

For some students, listening to music while studying works well because it keeps the brain activated, focused, and less prone to distractions. There is no single musical genre that is best for studying – it is entirely individual. Whether the lyrics in your child’s preferred music are appropriate is another discussion, but don’t automatically rule out hip-hop or heavy metal; it might work to focus your child.

Encourage your child to explore genres, and to use headphones with comfortable volume levels.

4. Music helps keep track of time.

Time blindness is common with ADHD, and music helps build time perception and awareness skills. Rather than have your child do homework or chores to the beat of a timer, try playing a song or timed playlist. It may be easier for your child to keep pace with a favorite soundtrack rather than an unstimulating timer or clock. Music also teaches predictability – a certain point in a song or playlist can act as a marker, letting your child know that it’s time to move to the next step or wrap up.

[Read: 9 Hacks to “Beat” ADHD Symptoms with Music]

5. Music boosts energy.

A good tune can pump up the brain and body, upping dopamine levels and increasing your child’s motivation to tackle even the least desirable of tasks. As with study music, have your child listen to different genres to see what works best. Ask them how they feel listening to each type of music – Are they more anxious? More in the zone? Perhaps too amped up and energized?

If your child has excess energy, music and movement are great ways to channel it. Try enrolling your young child into a developmental music program (such as Music Together, Kindermusik, Musikgarten), which helps build a variety of skills through the experience of music. Older children may benefit from dance classes or other group music experiences.

6. Music promotes calm.

Just as music can boost our energy, it can also calm and soothe us, making it an effective tool for emotional regulation. Again, the choice in music is personal. Some children relax to an audio track of nature or a composition without lyrics. Others feel calm and happy while listening to an upbeat pop song.

7. Music improves self-esteem.

Too many children with ADHD experience low self-esteem. Creating music and learning to play an instrument can build self-confidence and a skill in which they can take pride. It can also teach children about the importance of practice and persistence in the process of crafting something special and enjoyable.

Music is also quite normalizing – your child can bond with peers by talking about music, the instruments they play, and their favorite bands. Joining an orchestra or band at school is great for building social skills while pursuing musical interests. As music and movement are joined at the hip, many children benefit from dance, or another movement experience that works with music.

If your child wants to learn how to play an instrument, make sure to explore a variety of them – piano, drums, guitar, cello, etc. – to find the one that truly sings.

8. Music reinforces desired behaviors.

If listening to or performing music is a rewarding activity for your child, use it to encourage follow-through. Offer a jam session or music video, for example, after your child completes their homework.

9. Music encourages introspection.

Songwriting promotes emotional expression and introspection – exercises that can help children better understand their feelings, themselves, and how to effectively communicate their feelings to others. School-aged children can benefit from partaking in songwriting activities. With teens, who are just beginning to build their sense of self and independence, songwriting can be especially fruitful for self-exploration. Parents can learn a lot about their child’s emotional state, priorities, and passions through these exercises.

There are many ways to explore songwriting, including fill-in-the-blank exercises where children swap out known lyrics to a familiar tune with their own.

10. Music teaches empathy.

Lyric analysis teaches children about point-of-view, the thoughts and feelings of others, and self-reflection. Open up a discussion with your child about a favorite song and ask them to think about what the lyrics mean. What might the artist be trying to say? What clues do the lyrics provide? Try having your child write out the lyrics on paper to truly probe them.

Benefits of Music for ADHD Brains: Final Notes

• Keep a listening log of songs and music that energize, calm, and dysregulate your child as a handy reference.
• Use music intentionally for the outcomes you’re seeking. Background music, even if your child insists they aren’t tuning in, can influence behavior and feelings.
• Do not overuse music. Children (and all of us) need quiet time, too. Too much music can lead to the point of habituation, where the benefits music may be muffled or softened.
• Music lessons? Be honest with the teacher about your child’s strengths and roadblocks so they can plan ahead (they may reorganize the studio, for example, to eliminate distractions). Look for a flexible instructor who will experiment with different methods for alternative learners. Talk to a board-certified music therapist, who may teach lessons or refer you to someone who is a good match for your child’s needs.

The content for this article was derived from the ADDitude Expert Webinar “How Music Sparks, Soothes, and Optimizes the ADHD Brain in Children” (ADDitude ADHD Experts Podcast episode #335) with Patti Catalano, MM, MT-BC, which was broadcast live on December 2, 2020.

Benefits of Music: Next Steps

• Read: Music Therapy – Sound Medicine for ADHD
• Download: Music for Healthy ADHD Brains
• Read: How Music Unlocked My Son’s ADHD Brain

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The Attention Arcade is a gaming platform from BrainLeap Technologies that includes a collection of nine PC games that, thanks to an eye-tracker device purchased separately, use eye movements to control the on-screen action. Built on the premise that eyes and attention move in tandem, Attention Arcade promises to improve and strengthen focus and attention skills. For children with attention deficit hyperactivity disorder (ADHD or ADD), heightened attentional skills can boost working memory, inhibitory control, and cognitive flexibility. The Attention Arcade is the only gaze-driven intervention designed to train attention.

How Does the Attention Arcade Work?

The Attention Arcade is built on the scientific premise that attention and gaze usually shift simultaneously and share much of the same brain circuitry. The games leverage this connection with challenges designed to train different aspects of attention. A player uses their eyes to control the games via an eye tracker.

BrainLeap recommends 20 minutes of gameplay in the Attention Arcade, 3 to 5 times per week, for 8 to 12 weeks, to achieve optimal eye-movement control and attention skills. BrainLeap says that attention may improve after as few as 4 weeks.

Who Should Use the Attention Arcade?

The Attention Arcade is marketed to children ages 7 to 12 who want to improve attention skills, reading, math, executive function, and life outcomes. These games are designed for use at home or in school to make frequent training accessible and easy. The games are not compatible with Mac or Chromebook computers.

How Much Does the Attention Arcade Cost?

The price to download and play the PC games is $39 per month. To access the eye-tracker required to play the games, consumers can bundle the eye-tracker and games for $49/month or purchase the tracker directly at Amzn.to/3aA37bX.

What Studies Have Been Done On the Attention Arcade?

The games were initially created and tested at the University of California, San Diego, and research was funded by the National Institutes of Health. The clinical trial included individuals aged 9-25. All participants who completed the at-home training study showed improvements in at least one measure of attention and most showed improvements on multiple measures.

Sources

https://brainleaptech.com/