Lemborexant May Not Impair Postural Stability or Driving
Participants completed a practice driving test during screening, and driving performance was assessed at approximately nine hours after dosing on Days 2 and 9. Subjects were instructed to drive at 95 km/h within one lane for approximately one hour, while instruments on the vehicle measured their standard deviation of lateral position (SDLP).
The population’s mean age was 58.5, and 54.2% of participants were male. The mean increases from placebo in SDLP were less than 0.75 cm on both test days after all doses of lemborexant. These changes were neither statistically significant nor clinically meaningful. Zopiclone was associated with increases in SDLP of 2.04 cm on Day 2 and 1.88 cm on Day 9. These changes were statistically significant and clinically meaningful on both days.
The investigators categorized patients as between ages 21 and 65 or age 65 or older. The effects of lemborexant did not differ between adults older and younger than 65 or between males and females.
The driving instructor terminated three of 384 driving tests early. All participants whose tests were terminated had taken zopiclone.
The investigators did not observe any serious adverse events, severe treatment-emergent adverse events, or treatment-emergent adverse events leading to study discontinuation. The most common treatment-emergent adverse events reported after treatment with lemborexant were somnolence, headache, and dry mouth. The most common treatment-emergent adverse events reported after treatment with zopiclone were somnolence, dysgeusia, and dizziness.
Eisai and Purdue Pharma, the developers of lemborexant, funded the studies.
—Erik Greb
Suggested Reading
Murphy P, Moline M, Mayleben D, et al. Lemborexant, A dual orexin receptor antagonist (DORA) for the treatment of insomnia disorder: results from a Bayesian, adaptive, randomized, double-blind, placebo-controlled study. J Clin Sleep Med. 2017;13(11):1289-1299.
