FDA Approves Lemborexant For The Treatment Of Insomnia

Eli Ben-Yehuda

Written by Eli Ben-Yehuda

On May 31, 2020

DAYVIGO For Insomnia

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) approved DAYVIGO™. Lemborexant 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and or sleep maintenance.

The approval was based on a robust clinical development program that included two pivotal Phase 3 studies. They evaluated DAYVIGO versus placebo for up to one month and DAYVIGO versus placebo for six months. The FDA has recommended that DAYVIGO be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA).

DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.

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“Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being.” said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the DAYVIGO clinical studies and former Chairman of the Board of the National Sleep Foundation. “The clinical trials provide evidence that DAYVIGO may improve patients’ ability to fall asleep and stay asleep.”

How It Works

The mechanism of action of lemborexant in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R is thought to suppress wake drive. Lemborexant binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist with stronger inhibition effect to OX2R*.

The Clinical Trials

A team led by Margaret Moline, PhD, Executive Director, Neurology Business Group, Eisai, investigated whether lemborexant, an orexin receptor antagonist, can treat insomnia disorder in geriatric patients compared to a placebo and zolpidem tartrate extended release therapy.

The approval was based on the results of a clinical development program that included two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which evaluated DAYVIGO versus comparators for up to one month and DAYVIGO versus placebo for six-months, respectively, in a total of about 2,000 adult patients with insomnia. From these studies results, DAYVIGO demonstrated statistically significant superiorities on sleep onset and sleep maintenance compared to placebo in both subjective and objective evaluations.

The Food and Drug Administration has approved lemborexant (Dayvigo) for the treatment of insomnia in adults. The agency approved the drug for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.

Lemborexant will be available in 5-mg and 10-mg tablets after the Drug Enforcement Administration schedules the drug, which is expected to occur within 90 days, according to a statement from Eisai.

Lemborexant is an orexin receptor antagonist. Its approval is based on two phase 3 studies, SUNRISE 1 and SUNRISE 2, that included approximately 2,000 adults with insomnia. Investigators assessed lemborexant versus active comparators for as long as 1 month and versus placebo for 6 months.

Clinical Trial Findings:

In these studies, lemborexant significantly improved objective and subjective measures of sleep onset and sleep maintenance, compared with placebo. The medication was not associated with rebound insomnia or withdrawal effects after treatment discontinuation.

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In the phase 3 trials, somnolence was the most common adverse reaction that occurred in at least 5% of patients who received lemborexant and at twice the rate in patients who received placebo (lemborexant 10 mg, 10%; lemborexant 5 mg, 7%; placebo, 1%).

In a middle-of-the-night safety study, lemborexant was associated with dose-dependent worsening on measures of attention and memory, compared with placebo. Treatment did not meaningfully affect ability to awaken to sound, however.

Previously reported data showed that lemborexant was effective in male and female patients and was well tolerated by both sexes and that the medication did not impair postural stability and driving performance.

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