Solriamfetol for Attention-Deficit/ Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study

Objective: Some individuals with attention-deficit/hyperactivity disorder (ADHD) may not tolerate or adequately respond to currently available treatments. This study examined whether solriamfetol could have a favorable pattern of effects and tolerability as a treatment for ADHD in adults.Methods: Sixty adults with DSM-5 ADHD participated from August 2021 through January 2023 in a remotely conducted, randomized, double-blind, placebo-controlled, 6-week dose -optimization trial of 75 mg or 150 mg of solriamfetol. Measures included the Adult ADHD Investigator Symptom Rating Scale (AISRS), which was our primary outcome measure, as well as the Clinical Global Impressions scale (CGI), vital signs, the Global Assessment of Functioning (GAF), the Behavior Rating Inventory of Executive Function-Adult Form (BRIEF-A), the Epworth Sleepiness Scale (ESS), the Pittsburgh Sleep Quality Index (PSQI), and a modified Adult ADHD Self-Report Scale (MASRS). Results: Solriamfetol was well tolerated, with no significant effect on mean heart rate (+3.7 vs +2.2 bpm, P=.5609), systolic blood pressure (+2.4 vs +1.5 mm Hg, P=.6474), or diastolic blood pressure (+1.1 vs +1.5 mm Hg, P=.8117). There was no statistically significant treatment effect on occurrence of adverse events. Compared to individuals on placebo, individuals on solriamfetol treatment experienced adverse events at a rate of at least 10 percentage points higher in the categories of decreased appetite, headache, gastrointestinal, insomnia, increased energy, cardiovascular, and neurologic. Compared to individuals on placebo, by study endpoint, a greater proportion of individuals in the treatment group met the a priori -defined treatment response (CGI score indicating much or very much improved and AISRS score reduced >= 25%: 45% vs 6.9%, P=.0020); those treated with solriamfetol also had greater improvement in total AISRS scores by week 3 through week 6 (P=.0012; week 6 effect size=1.09). Significantly more solriamfetoltreated adults than placebo-treated adults had 0.5-standard deviation improvement in T-score on the BRIEF-A Global Executive Composite (P=.0173); those treated with solriamfetol also had greater mean change in GAF score (-4.8 vs-0.3, P=.0006) and greater mean MASRS total score change (P=.0047; effect size=1.23). Mean ESS score improved more with solriamfetol than with placebo (P=.0056), but this difference did not predict AISRS response (P=.3735). There was no significant association between solriamfetol and change in PSQI scores.Conclusions: Solriamfetol may be a novel and effective treatment for the management of ADHD in adults. Further replication in larger trials is indicated.Trial Registration: ClinicalTrials.gov identifier: NCT04839562