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- Title
Effects of solriamfetol on on‐the‐road driving in participants with narcolepsy: A randomised crossover trial.
- Authors
Vinckenbosch, Frederick; Lammers, Gert Jan; Overeem, Sebastiaan; Chen, Dan; Wang, Grace; Carter, Lawrence P.; Zhou, Kefei; Ramaekers, Johannes G.; Vermeeren, Annemiek
- Abstract
Objective: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on‐the‐road driving performance in participants with narcolepsy. Methods: In this randomised, double‐blind, placebo‐controlled, crossover study, driving performance during a 1 h on‐road driving test was assessed at 2 and 6 h post‐dose following 7 days of treatment with solriamfetol (150 mg/day for 3 days, followed by 300 mg/day for 4 days) or placebo. The primary endpoint was standard deviation of lateral position (SDLP) at 2 h post‐dose. Results: The study included 24 participants (54% male; mean age, 40 years); 22 had evaluable SDLP data. At 2 h post‐dose, median SDLP was significantly lower (improved) with solriamfetol compared with placebo (19.08 vs. 20.46 cm [median difference, −1.9 cm], p = 0.002). Four participants on solriamfetol and 7 on placebo had incomplete driving tests. At 6 h post‐dose, median SDLP was not statistically significantly different with solriamfetol compared with placebo (19.59 vs. 19.78 cm [median difference, −1.1 cm], p = 0.125). Three participants on solriamfetol and 10 on placebo had incomplete driving tests. Common adverse events (≥5%) included headache, decreased appetite, and somnolence. Conclusions: Solriamfetol 300 mg/day improved on‐the‐road driving performance, at 2 h post‐administration in participants with narcolepsy.
- Subjects
CROSSOVER trials; NARCOLEPSY; DOPAMINE uptake inhibitors; OREXINS; MOTOR vehicle driving; WAKEFULNESS
- Publication
Human Psychopharmacology: Clinical & Experimental, 2023, Vol 38, Issue 1, p1
- ISSN
0885-6222
- Publication type
Article
- DOI
10.1002/hup.2858