In:
Human Psychopharmacology: Clinical and Experimental, Wiley, Vol. 37, No. 6 ( 2022-11)
Abstract:
To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on‐the‐road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). Methods Eligible participants were aged 21–75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency 〈 30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days] ) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on‐road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint. Results Solriamfetol significantly reduced SDLP at 2 ( n = 34; least squares mean difference, –1.1 cm; 95% CI, –1.85, –0.32; p = 0.006) and 6 hours postdose ( n = 32; least squares mean difference, –0.8 cm; 95% CI, –1.58, –0.03; p = 0.043). Two hours postdose, 4 placebo‐treated and 1 solriamfetol‐treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment‐emergent adverse events included headache, nausea, and insomnia. Conclusions Solriamfetol 300 mg/day significantly improved on‐the‐road driving performance in participants with EDS associated with OSA.
Type of Medium:
Online Resource
ISSN:
0885-6222
,
1099-1077
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2001446-6
SSG:
15,3
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