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

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

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.

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.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

��ɫ��

��ɫ��