Wednesday, August 15, 2018

FDA Approves Bedtime ADHD Medication

The Food and Drug Administration has approved Jornay PM (extended-release methylphenidate capsules) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. The oral medication is a novel formulation of methylphenidate, which is taken in the evening in order to reduce the severity of early-morning ADHD symptoms the following day.

The approval of Jornay PM was based in part on the results of two clinical trials, involving 278 children aged 6 to 12 who met DSM-5 criteria for ADHD inattentive, hyperactive-impulsive, or combined inattentive/hyperactive-impulsive subtypes. Children who took Jornay PM at night were found to have lower ADHD symptoms in the early morning and throughout the day than those taking placebo. The most common adverse reactions (incidence of ≥ 5% and at a rate at least twice placebo) reported during the trial included insomnia, decreased appetite, headache, vomiting, nausea, psychomotor hyperactivity, and exaggerated mood swings.

Jornay PM is available in 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg doses. It is recommended that patients 6 years and above start at 20 mg daily.

“The FDA approval of this agent would appear to add to the armamentarium of medications available for clinicians to treat ADHD,” Robert M. Bilder, Ph.D., the Michael E. Tennenbaum Family Professor of Psychiatry & Biobehavioral Sciences at UCLA David Geffen School of Medicine, told Psychiatric News by email. “The formulation, which involves use of a proprietary coating to delay release, appears to have been associated with benefits especially with early morning dysfunction associated with ADHD, which is a significant clinical problem.”

Bilder added, “The pivotal trials used placebo rather than another active treatment, so it remains unclear if Jornay PM has any benefits relative to other agents with demonstrated efficacy.”

(Image: iStock/monkeybusinessimages)


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