RT Journal Article
SR Electronic
T1 Effects of solriamfetol on real-world driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 17
DO 10.1183/23120541.sleepandbreathing-2021.17
VO 7
IS suppl 7
A1 F Vinckenbosch
A1 J Asin
A1 N De Vries
A1 P E Vonk
A1 G J Lammers
A1 S Overeem
A1 H Janssen
A1 G Wang
A1 D Chen
A1 L Carter
A1 K Zhou
A1 A Vermeeren
A1 J G Ramaekers
YR 2021
UL http://openres.ersjournals.com/content/7/suppl_7/17.abstract
AB 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.FootnotesCite this article as ERJ Open Research 2021; 7: Suppl. 7, 17.This is an ERS Lung Science Conference abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).