Effects of solriamfetol on real-world driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea

Abstract

Background: Excessive daytime sleepiness (EDS) in people with obstructive sleep apnoea (OSA) is associated with increased driving accident risk. Solriamfetol [Sunosi™] is a dopamine/norepinephrine reuptake inhibitor approved in the EU and US to treat EDS in adults with OSA (37.5–150mg/d). Aim: Evaluate solriamfetol’s effects on on-road driving performance in adults with EDS associated with OSA. Methods: In a randomised, double-blind, crossover study (NCT02806895/EudraCT 2015-003930-28), an on-road driving test was conducted at 2h and 6h postdose after 7d of treatment with solriamfetol (150mg/d×3d, then 300mg/d×4d) or placebo. Primary endpoint: standard deviation of lateral position (SDLP), a measure of weaving, at 2h postdose. Results: Baseline characteristics (N=34): 88% male; mean age, 52y; mean Epworth Sleepiness Scale, 14.4; Maintenance of Wakefulness Test, 14.3 min. At 2h and 6h, mean SDLP was significantly lower with solriamfetol vs placebo (Fig.). At 2h, 1 participant on solriamfetol and 4 on placebo had incomplete driving tests; at 6h, 3 and 7 participants, respectively, had incomplete driving tests. Common adverse events with solriamfetol: headache, nausea, insomnia, dizziness, and agitation. Conclusion: Solriamfetol (300mg/d) improved SDLP, an important measure of driving performance, at 2h and 6h postdose in participants with EDS associated with OSA.