Effects of solriamfetol on on-the-road driving in participants with narcolepsy: a randomised crossover trial

Vinckenbosch, F.; Lammers, G.J.; Overeem, S.; Chen, D.; Wang, G.; Carter, L.P.; ... ; Vermeeren, A. (2022)

Article / Letter to editor

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.

• clinical trials
• CNS
• efficacy
• neurology
• pharmacotherapy

• All authors: Vinckenbosch, F.; Lammers, G.J.; Overeem, S.; Chen, D.; Wang, G.; Carter, L.P.; Zhou, K.F.; Ramaekers, J.G.; Vermeeren, A.
• Date: 2022-11-24
• Journal: Human Psychopharmacology: Clinical and Experimental
• Volume: 38
• Issue: 1
• DOI: doi:10.1002/hup.2858