Many insomnia treatments are associated with residual morning sleepiness that presents safety risks. LEM has been evaluated for this potential in several studies.

Data presented here are derived from 3 randomized, double-blind, placebo-controlled studies that evaluated LEM 5mg (LEM5) and 10mg (LEM10) in both healthy volunteers and subjects with insomnia. Potential next-morning residual effects were assessed via an on-the-road driving test (Study 1); postural stability (falls risk indicator) and tests of attention and memory shortly after waketime (Study 2 and Study 3); and subject-reported ratings of morning sleepiness/alertness (Study 3).

Study 1: In 48 healthy subjects, there were no statistically significant effects after single or repeated doses of LEM5 or LEM10 on next-morning driving performance. Study 2: In older healthy subjects (n=63; ≥55 years), at 8 hours post-dose, there was no evidence for residual morning effects of LEM5 or LEM10 measured by body sway, or significant effects of LEM5 or LEM10 on tests of attention and memory. Study 3: In older subjects with insomnia (n=1006; ≥55 years), there was a significant increase in morning alertness with LEM5 and LEM10 compared to placebo over the first and last 7 mornings of the 1-month treatment period (p<0.05). Similar to the healthy older subjects in Study 2, there were no significant differences in body sway upon morning awakening, continuity of attention, quality of memory, or speed of memory retrieval for either LEM group versus placebo; only power of attention (reaction time) was slightly but significantly slower than placebo.

Lemborexant at therapeutic dose levels was not associated with clinically important next-morning residual effects as assessed using multimodal, clinically meaningful measures of driving performance, postural stability, and cognition.