FDA approves Lemborexant for treating Insomnia in adults

The Food and Drug Administration has approved lemborexant (Dayvigo) for the treatment of insomnia in adults. The FDA approved the drug for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance. The drug will be available in 5 mg and 10 mg doses early in 2020 following scheduling by the Drug Enforcement Administration.

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 signalling 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 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.

Across SUNRISE 2 and SUNRISE 1, DAYVIGO was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects following DAYVIGO discontinuation at either dose. In addition, the development program included multiple safety studies evaluating effects on postural stability, cognition, driving performance and respiratory safety.

"Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being,"² 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."

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"We believe the approval of Dayvigo is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai, in a statement.¹ "We look forward to making this new therapeutic option available to the millions of patients who suffer from insomnia."

Subjective wake after sleep onset decreased 17.3 minutes (95% CI, -22.5 to -12.0) in the 5-mg group and 18.7 minutes (95% CI, -24.1 to 13.3) in the 10-mg group after 1 month, followed by decreases of 36.1 and 31.5 minutes, respectively, at 6 months. After 1 year, the 5-mg and 10-mg groups had subjective wake after sleep onset decreases of 42.9 and 43.8 minutes, respectively.

Notably, rebound insomnia and withdrawal effects were not reported after discontinuation of lemborexant.

The most common adverse events reported in SUNRISE 1 and SUNRISE 2 was somnolence (10 mg, 10%; 5 mg, 7%; placebo, 1.0%). The most common adverse events leading to discontinuation of lemborexant were somnolence (10 mg, 1.0%; 5 mg, 0.7%; placebo, 0.4%) and nightmares (10 mg, 0.3%; 5 mg, 0.3%; and placebo, 0%).

"We believe the approval of DAYVIGO is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai. "We look forward to making this new therapeutic option available to the millions of patients who suffer from insomnia.

Eisai has submitted new drug applications seeking approval of this agent for use in the treatment of insomnia in Japan (March 2019) and Canada (August 2019).

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statement from Eisai