Abstract Details

Title Effects of Solriamfetol on Driving Performance in Participants With Narcolepsy

Topic Sleep

Presentation(s) S9 - Sleep: Highlight Presentations on RBD (2:00 PM-2:08 PM)

Poster/Presentation
Number 001

Objective The aim of this study was to evaluate the effects of solriamfetol on on-road driving performance in participants with narcolepsy.

Background Patients with narcolepsy have an increased risk of automobile accidents. Solriamfetol (Sunosi^®), a dopamine/norepinephrine reuptake inhibitor, is approved in the US and EU to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75–150 mg/day).

Design/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 (1-hour drive on a public highway) was assessed at 2 hours and 6 hours 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. For assessment of driving performance, the primary endpoint was standard deviation of lateral position (SDLP), a measure of “weaving” (departure from a steady lane position), at 2 hours post-dose. Wilcoxon signed-rank test was used for comparisons between solriamfetol and placebo.

Results The study included 24 participants (54% male; mean age, 40 years); 22 were included in the analyses of SDLP. At 2 hours post-dose, median SDLP was statistically significantly lower for participants treated with solriamfetol versus placebo (19.08 vs 20.46 cm; P=0.0022), indicating better driving performance with solriamfetol. At 2 hours post-dose, 4 participants receiving solriamfetol and 7 participants receiving placebo failed to complete the driving test. At 6 hours post-dose, median SDLP for solriamfetol was not statistically different from that for placebo (19.59 vs 19.78 cm; P=0.1245). At 6 hours post-dose, 3 participants receiving solriamfetol and 10 participants receiving placebo failed to complete the driving test. Common adverse events (≥5%) were headache, decreased appetite, somnolence, sleep disorder, agitation, nausea, and palpitations.

Conclusions Solriamfetol (300 mg/day) improved SDLP, an important measure of driving performance, at 2 hours after administration in participants with narcolepsy.

Authors/Disclosures
Frederick Vinckenbosch (Maastricht University) PRESENTER	The institution of Frederick Vinckenbosch has received research support from Jazz pharmaceuticals.
Gerrit J. Lammers, MD (LUMC)	The institution of Dr. Lammers has received research support from Takeda.
	No disclosure on file
Dan Chen (Jazz Pharmaceuticals)	Dan Chen has received personal compensation for serving as an employee of Jazz Pharmaceuticals, Inc..
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

��ɫ��

��ɫ��