Clinical trial demonstrates benefits of solriamfetol for adults with ADHD

Newswise — BOSTON – Although several medications are approved to treat attention-deficit/hyperactivity disorder (ADHD), some individuals experience limited benefits from the drugs or develop side effects from their use. A recent clinical trial published in the Journal of Clinical Psychiatry by investigators at Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB), has demonstrated that the drug solriamfetol may be an effective alternative for managing ADHD in adults.

Solriamfetol is currently approved in the United States for treating excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea. The drug increases the amounts of certain natural substances in the brain—specifically, dopamine and norepinephrine—that control sleep and wakefulness, thus sharing some of the properties of current ADHD medications.

To test the potential of solriamfetol for treating ADHD, researchers randomized 60 adults with the condition to solriamfetol (75 or 150 mg) or placebo for 6 weeks. Participants were interviewed serially using the primary outcome measure for the trial, the Adult ADHD Investigator Symptom Rating Scale (AISRS).  ADHD symptoms were further evaluated by a patient-reported measure. ADHD related impairment was assessed using the Clinical Global Impressions scale (CGI), and executive function challenges were measured using the participant rated Behavior Rating Inventory of Executive Function-Adult Form (BRIEF-A).

By the end of the study, a greater proportion of individuals taking solriamfetol had improved measures on all of these scales, when compared with patients taking placebo.

Solriamfetol had no significant effect on sleep quality as evaluate by the Pittsburgh Sleep Quality Index, or on average heart rate or blood pressure. Adverse experiences that occurred at a higher numerical rate than placebo fell under the categories of decreased appetite, headache, gastrointestinal symptoms, insomnia, increased energy, cardiovascular and neurologic effects.

“Our results suggest that solriamfetol may be a safe and effective treatment for ADHD in adults. Larger studies replicating these findings could confirm the strong evidence of benefit and the tolerability of this agent as a treatment,” says lead author Craig B.H. Surman, MD, the Director of the Clinical and Research Program in Adult ADHD at MGH and Associate Professor of Psychiatry at Harvard Medical School. “Although there are currently safe and effective treatments for ADHD, they are not effective for all individuals with ADHD or tolerated well by all patients. Our findings offer hope of a new method of supporting the daily challenges that individuals with ADHD face.”

Additional authors include Daniel M. Walsh, BA; Nora Horick, MS; Maura DiSalvo, MPH; Chloe Hutt Vater, BA; and Daniel Kaufman, BS.

This research was an investigator-initiated trial supported by Jazz Pharmaceuticals and Axsome Therapeutics. Materials for this study were provided by Jazz Pharmaceuticals and Axsome Therapeutics.