Abstract Details

Title Insomnia treatments and on-the-road driving performance: a systematic literature review

Topic Sleep

Presentation(s) Sleep Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 005

Background

Insomnia involves difficulty falling asleep or maintaining sleep and may result in fatigue and reduced quality of life. Some insomnia treatments may impair next-day driving performance. Lemborexant is a new dual orexin receptor agonist (DORA) approved as an insomnia treatment.

Objective This systematic literature review compared the impact of lemborexant and other insomnia treatments on next-day driving performance.

Design/Methods Searches were conducted in Medline and Embase through May 2019 and in clinical trial registries. Randomized controlled trials (RCTs) included measured performance in standardized on-road driving tests in healthy volunteers or people with insomnia, were published in English, and had at least one group randomized to a recommended dose of: benzodiazepines, z-drugs, trazodone, ramelteon or DORAs. Quality of evidence was assessed using National Institute for Health and Care Excellence (NICE) checklist for RCTs. Pairwise random-effects meta-analyses were conducted using the difference between each active treatment and placebo in standard deviation of lateral position (SDLP). Interpretation of clinical significance was based on the established benchmark equating a difference in SDLP versus placebo of +2.4 cm with a blood alcohol concentration of 0.05%.

Results In total, 14 studies were included. Clinically significant differences in SDLP compared with placebo were shown in healthy volunteers for zopiclone (10/10 studies) and ramelteon (1/1 study), and in people with insomnia for flunitrazepam (2/3 studies). Premature termination of the driving test was reported most frequently for zopiclone (5/10 studies). Lemborexant 5 or 10 mg had no statistically or clinically significant difference from placebo in SDLP, and no premature driving test terminations (1/1 study).

Conclusions Zopiclone, ramelteon, and flunitrazepam were associated with impaired driving performance, similar to driving under the influence of alcohol. Premature test termination was reported most frequently for zopiclone. Lemborexant 5 or 10 mg had no statistically or clinically significant effect on driving performance nor premature driving test terminations.

Authors/Disclosures
Genevieve Meier PRESENTER	Genevieve Meier has received personal compensation for serving as an employee of Eisai.
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