Lemborexant Use Does Not Affect Next-Day Driving Performance


In a phase 1 safety study, healthy adult volunteers, mean age 58.5 (age range 23-78 years), who took lemborexant (Eisai, Woodcliff Lake, NJ and Purdue, Stamford, CT) at bedtime, had no impairment of driving performance the next morning compared with volunteers who took placebo. Results of the study will be published in the journal Sleep. Lemborexant is an investigational drug that has been studied for treatment of insomnia in adults. 

The ability to wake and engage in daily activities of living safely after taking an insomnia treatment is an important concern for anyone who uses medication to help themselves sleep. Many medications for insomnia are known to cause sleepiness the following morning and driving safely is a particular concern. In this study, the ability to wake and perform well was measured in an on-the-road test in a real vehicle mimicking real-world conditions—with a driving instructor and dual controls to ensure participant’s safety. The study also followed Food and Drug Administration (FDA) guidance in its inclusion of a positive control, subjects over age 65, initial and steady-state tests, and crossover design.

Driving performance was tested after volunteers (n = 24, age 23 to 65; n = 24, age 65-78) took 1 of the 3 doses of lemborexant (2.5 mg, 5 mg, and 10 mg) or placebo for 8 nights, after both the first and eighth nights. In the active-control arm of the study, subjects took 7.5 mg zopiclone (known to cause next-day sleepiness and next-day driving impairment) on the 1st night and 8th night only with placebo in between. All subjects completed 4 treatment arms (2 different doses of lemborexant, placebo, and active control).

The on-road test lasted for approximately 1 hour at a speed of approximately 60 miles per hour in a car instrumented to measure deviation, or weaving, with respect to the left lane marking. At all doses and both time periods, the drivers who had taken lemborexant had weaving that was not significantly different than when they had taken placebo (= .30-.65). In contrast, the drivers who had taken zopiclone had more than 2 cm (least squares average) more weaving than when they had taken placebo (< .003).

As reported previously in Practical Neurology, in phase 3 safety and efficacy studies, patients with insomnia who took lemborexant got to sleep faster compared to those treated with placebo, woke in response to auditory stimuli, and returned to sleep effectively after waking. Lemborexant is an orexin receptor antagonist thought to act on the sleep-wake cycle by inhibiting the wakefulness promoted by the orexin neurotransmitter system.

Margaret Moline, PhD, International Project Team Lead for the lemborexant clinical development program said, “Studies like this one, where subjects drive in a real-world setting, provide important, easily relatable information about the potential risk of residual morning sleepiness. The lemborexant data support the safety and tolerability of the doses that we showed to be effective in treating patients with insomnia.”


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