0763 Effects Of Solriamfetol On Driving Performance In Participants With Narcolepsy

F. Vinckenbosch, G. Lammers, S. Overeem, D. Chen, G. Wang, L. Carter, K. Zhou, J. Ramaekers, A. Vermeeren

Research output: Contribution to journalConference Abstract/Poster in journalAcademic

Abstract

Introduction Patients with narcolepsy have an increased risk of automobile accidents. Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the US (Sunosi®) for adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75-150 mg/day). This study evaluated the effects of solriamfetol on on-road driving performance in participants with narcolepsy. Methods In each period of this randomized, double-blind, placebo-controlled, crossover study (NCT 02806908; EudraCT 2015-003931-36), driving performance during an on-road driving test (a 1-hour drive on a public highway) was assessed at 2 hours and 6 hours postdose following 7 days of treatment with solriamfetol (150 mg/day × 3, then 300 mg/day × 4) or placebo. For assessment of driving performance, the primary endpoint was standard deviation of lateral position (SDLP), a measure of “weaving,” at 2 hours postdose. Comparisons (solriamfetol vs placebo) used a Wilcoxon signed-rank test. Results The study included 24 participants (54% male; mean age, 40 years); 22 were included in the analyses of SDLP data. At 2 hours postdose, SDLP for solriamfetol (median, 19.08 cm) was statistically significantly lower than that for placebo (median, 20.46 cm; P=0.0022; incomplete driving tests: solriamfetol, n=4; placebo, n=7), indicating a better performance with solriamfetol. At 6 hours postdose, SDLP for solriamfetol (median, 19.59 cm) was not statistically significantly different from that for placebo (median, 19.78 cm; P=0.1245; incomplete driving tests: solriamfetol, n=3; placebo, n=10). Common adverse events (≥5%) were headache, decreased appetite, somnolence, sleep disorder, agitation, nausea, and palpitations. Conclusion Solriamfetol (300 mg/day) improved SDLP, an important measure of driving performance, at 2 hours after administration in participants with narcolepsy. Support Jazz Pharmaceuticals
Original languageEnglish
Pages (from-to)A290-A290
Number of pages1
JournalSleep
Volume43
Issue numberS1
DOIs
Publication statusPublished - Apr 2020
Event34th Annual Meeting of the Associated Professional Sleep Societies - Online, United States
Duration: 27 Aug 202030 Aug 2020

Cite this