Effects of solriamfetol on on‐the‐road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea

OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on‐the‐road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). METHODS: Eligible participants were aged 21–75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency <30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days]) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on‐road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint. RESULTS: Solriamfetol significantly reduced SDLP at 2 (n = 34; least squares mean difference, –1.1 cm; 95% CI, –1.85, –0.32; p = 0.006) and 6 hours postdose (n = 32; least squares mean difference, –0.8 cm; 95% CI, –1.58, –0.03; p = 0.043). Two hours postdose, 4 placebo‐treated and 1 solriamfetol‐treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment‐emergent adverse events included headache, nausea, and insomnia. CONCLUSIONS: Solriamfetol 300 mg/day significantly improved on‐the‐road driving performance in participants with EDS associated with OSA.