Margaret Moline, PhD

“We hope that this will provide a useful option, a potential option, for clinicians to consider when their patients have difficulty falling asleep or staying asleep, because it’s important not only to treat the symptoms, but also to make sure that they can wake well and that’s what these special studies were intended to help us understand.”

At the 2019 American Academy of Neurology’s (AAN) Annual Meeting in Philadelphia, Pennsylvania, the results were presented from 3 randomized, double-blind, placebo-controlled studies that evaluated lemborexant 5 mg and 10 mg in healthy volunteers and subjects with insomnia to assess the potential for next-morning residual effects.

Potential next-morning residual effects were assessed in 3 studies through clinically meaningful measures of driving performance, postural stability, and cognition.

It was reported that in Study 1, which assessed the effects via an on-the-road driving test, there were no statistically significant effects after both single or repeated doses of lemborexant 5 mg or 10 mg on next-morning driving performance. In older healthy subjects in Study 2 at 8 hours post-dose, there was no indication of residual morning effects from either dosage measured by body sway, or significant effects on tests of attention and memory. In Study 3, in older subjects with insomnia, investigators reported a significant increase in morning alertness with both lemborexant 5 mg and 10 mg versus placebo over the first and last 7 mornings of the 1-month treatment period. Additionally, in Study 3, there were no meaningful differences in body sway upon awakening, continuity of attention, quality of memory, or speed of memory retrieval for either lemborexant doses versus placebo; power of attention was slightly but significantly slower than placebo.

The 3 studies found that at therapeutic dose levels, lemborexant was not associated with clinically important next-morning residual effects.

To find out more about the results from these 3 studies, 

spoke with Margaret Moline, PhD, International Project Team Lead of lemborexant at Eisai Inc., on the floor of the AAN meeting.

1. Murphy P, Kumar D, Pinner K, et al. Effects of Lemborexant in the Morning: Results From 3 Randomized Studies. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA. Abstract S46.007.

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The International Project Team Lead spoke about the results of study endpoints that assessed the potential for next-morning residual effects of lemborexant, which is in development for insomnia.

Margaret Moline, PhD

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Margaret Moline, PhD: Next-Morning Residual Effects of Lemborexant in Insomnia