Study Objectives
This systematic literature review and meta-analysis explored the impact of lemborexant and other insomnia treatments on next-day driving performance.
Methods
Searches were conducted in MEDLINE ® and Embase ® on 16 May 2019, supplemented by clinical trial registries. Randomized controlled trials in healthy volunteers or people with insomnia were included if they reported a standardized on-road driving test, were published in English and included ≥1 group receiving a recommended dose of flunitrazepam, estazolam, triazolam, temazepam, brotizolam, etizolam, alprazolam, lorazepam, zolpidem, eszopiclone, zaleplon, zopiclone, trazodone, ramelteon, lemborexant, or suvorexant. Pairwise random-effects meta-analyses used the difference between each active treatment and placebo in standard deviation of lateral position (ΔSDLP). ΔSDLP of +2.4 cm, established as equivalent to a blood alcohol concentration of 0.05%, was considered clinically significant.
Results
Fourteen studies were included. Clinically significant differences in ΔSDLP 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 test termination was reported most frequently for zopiclone (5/10 studies) and was reported in two subjects for suvorexant (1/2 studies), one for flunitrazepam (1/3 studies) and one for placebo (1/12 studies). Lemborexant had no statistically or clinically significant ΔSDLP, and no premature driving test terminations.
Conclusions
Zopiclone, flunitrazepam and ramelteon were associated with impaired driving performance, similar to driving under the influence of alcohol. Premature test termination was reported most frequently for zopiclone, and also for suvorexant, flunitrazepam and placebo. Lemborexant had no statistically or clinically significant effect on driving performance.
