Effects of Solriamfetol on Driving Performance in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea

Introduction: Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved (US and EU) to treat excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA; 37.5–150mg/day). This study evaluated solriamfetol’s effects on driving performance in participants with EDS associated with OSA.

Methods: In this randomized, double-blind, crossover study (NCT02806895/EudraCT 2015-003930-28), on-road driving performance was assessed at 2 and 6 hours post-dose following 7 days of solriamfetol (150mg/day × 3, then 300mg/day × 4) or placebo. The primary endpoint—standard deviation of lateral position (SDLP), a measure of “weaving,” at 2 hours post-dose—was analyzed using a repeated mixed-effects analysis of variance model.

Results: Baseline characteristics reflected the broader OSA population (N=34; 88% male; mean age, 52 years; mean Epworth Sleepiness Scale score, 14.4; Maintenance of Wakefulness Test sleep latency, 14.3 minutes). At 2 hours post-dose, SDLP was significantly lower following solriamfetol (least squares [LS] mean, 18.83 cm) versus placebo (19.92 cm): LS mean difference, -1.08 cm; 95% confidence interval (CI), -1.85, -0.32; P=0.0062; 1 participant receiving solriamfetol and 4 receiving placebo failed to complete the driving test. At 6 hours post-dose, SDLP was significantly lower following solriamfetol (19.24 cm) versus placebo (20.04 cm): LS mean difference, -0.80 cm; 95% CI, -1.58, -0.03; P=0.0432; 3 participants receiving solriamfetol and 7 receiving placebo failed to complete the driving test. Common adverse events (≥5%): headache, nausea, insomnia, dizziness, and agitation.

Conclusion: Solriamfetol (300mg/day) improved SDLP, an important measure of driving performance, at 2 and 6 hours in participants with EDS associated with OSA.