ADHD News & Research

New Study: Dasotraline Effective in Treating ADHD in Children

New research indicates that 4 mg of the medication dasotraline effectively treats ADHD symptoms in children aged 6 to 12 years. The medication is not yet available, as the FDA required additional clinical data before evaluating its efficacy and tolerability for the treatment of ADHD.

In May 2020, Sunovion Pharmaceuticals Inc., halted its drug development program for dasotraline, withdrawing both New Drug Applications (NDA) for ADHD and BED (binge-eating disorder). “We believe that further clinical studies would be needed to support a regulatory approval for dasotraline in these indications,” the company said in a press release.

September 5, 2019

Encouraging new research suggests that the medication dasotraline, a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), may be one step closer to FDA approval for the treatment of ADHD in children. The study, published in the Journal of Attention Disorders,1 found that 4 mg of dasotraline is an effective and tolerable treatment for attention deficit hyperactivity disorder (ADHD or ADD) in children aged 6 to 12 years.

The research was conducted by dasotraline manufacturer Sunovion Pharmaceuticals Inc., in conjunction with AVIDA Inc. and the Center for Psychiatry and Behavioral Medicine in Las Vegas, in response to the U.S. Food and Drug Administration (FDA) and its 2018 request for additional clinical data on dasotraline’s efficacy and tolerability for the treatment of ADHD. The FDA said it could not approve dasotraline’s New Drug Application for ADHD treatment without additional research like this.

The randomized, double-blind study included 112 children with ADHD, ages 6 to 12 years, half of whom received a once-daily evening dose of dasotraline 4 mg or placebo for 14 days. On days 0 and 15, researchers measured the severity of ADHD symptoms by administering the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and the Permanent Product Measure of Performance (PERMP) math test.

Participants treated daily with dasotraline had significantly greater least squares (LS) mean improvement from their baseline to Day 15 in the SKAMP-combined score, in the SKAMP-attention subscale score, and in the SKAMP-deportment subscale scores. Despite the potential adverse side effects of insomnia (19.6% vs 3.6% prevalence in the placebo group), headaches (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%), researchers found dasotraline to be an effective ADHD medication.

Dasotraline has not been approved by the FDA for the treatment of ADHD or binge eating disorder, for which it is also indicated.


1 Wigal, S. B., Hopkins, S. C., Koblan, K. S., Childress, A., Kent, J. M., Tsai, J… Goldman, R. “Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study.” Journal of Attention Disorders. (Aug.2019)