The FDA has approved a new medication called Mydayis for attention deficit hyperactivity disorder (ADHD). Mydayis is a central nervous system stimulant taken once a day in the morning. It is approved for patients 13 years and older. The drug works by helping to improve focus and reduce impulsivity and hyperactivity. Clinical trials showed it can be effective for up to 16 hours, which is longer than many other ADHD medications. However, this long duration also raises the chance of insomnia, especially if taken too late. The approval was based on studies in adults ages 18 to 55 and teens ages 13 to 17. The FDA did not approve Mydayis for children 12 and younger because they had higher levels of the drug in their blood and more side effects like insomnia and decreased appetite. For patients who qualify, Mydayis offers a new once-daily option. But it is important to talk to your doctor about whether this medicine is right for you or your teen. Your doctor can help weigh the benefits against possible side effects and suggest the best treatment plan.
FDA approved Mydayis (mixed salts of a single-entity amphetamine) for ADHD in Patients 13 and OlderFDA approved new ADHD drug Mydayis for patients 13 and older
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The FDA has approved Mydayis (mixed salts of a single-entity amphetamine) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 13 years and older. Mydayis is a central nervous system stimulant that is administered once daily upon awakening. The approval was based on clinical trials in adults (18 to 55 years) and pediatric patients (13 to 17 years). Clinicians should note that the drug's effects may last up to 16 hours, which carries a potential for insomnia. The label also warns that pediatric patients 12 years and younger experienced higher plasma exposure and higher rates of adverse reactions, mainly insomnia and decreased appetite, and thus the drug is not indicated for that age group.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mechanism of action in ADHD is not known.
Mydayis is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Limitations of Use: Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite.
Mydayis should be administered once daily upon awakening. The recommended starting dose for adults (18 to 55 years) is 12.5 mg once daily, with titration in increments of 12.5 mg no sooner than weekly, up to a maximum of 50 mg daily. For pediatric patients (13 to 17 years), the starting dose is 12.5 mg once daily, with titration up to a maximum of 25 mg daily. In adult patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m2), the maximum dose is 25 mg daily; use in ESRD is not recommended. In pediatric patients with severe renal impairment, the maximum dose is 12.5 mg. Mydayis may be taken with or without food, but patients should be consistent. Capsules may be swallowed whole or opened and sprinkled over applesauce. Do not substitute for other amphetamine products on a milligram-per-milligram basis.
Efficacy of Mydayis in ADHD was established in three short-term trials in adults (18 to 55 years, Studies 1, 2, and 3) and two short-term trials in pediatric patients (13 to 17 years, Studies 4 and 5). Specific efficacy results are not reported in the label.
Prior to treatment, assess for presence of cardiac disease (careful history, family history of sudden death or ventricular arrhythmia, and physical exam). Evaluate for motor or verbal tics or Tourette's syndrome. Because effects may last up to 16 hours, administer upon awakening to avoid insomnia. Do not administer later in the day if a dose is missed. Acidifying agents (e.g., ascorbic acid) decrease amphetamine blood levels; alkalinizing agents (e.g., sodium bicarbonate) increase levels. Adjust dosage accordingly.
Mydayis offers a once-daily formulation with a long duration of effect (up to 16 hours) for ADHD patients 13 years and older. It is not indicated for younger children due to higher exposure and adverse reactions. Dosing is limited in renal impairment.
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