Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced that the U.S. Food and Drug Administration has approved Dayvigo (lemborexant) 5 mg and 10 mg for the treatment of adult patients with sleep-onset insomnia and sleep maintenance insomnia. According to Eisai, the insomnia treatment approval was based on a clinical development program that included two Phase 3 studies, which evaluated Dayvigo versus placebo for up to one month and 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). Eisai reported that Dayvigo will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
Eisai lemborexant is a dual orexin receptor antagonist. Orexin signaling is believed to promote periods of wakefulness. Lemborexant inhibits orexin signaling by binding to both orexin receptor subtypes.
Sleepiness is the most common adverse reaction reported by people treated with Dayvigo. Therefore, lemborexant should not be used by patients who have narcolepsy. Read the complete prescribing information for Dayvigo.
In 2014 the FDA approved Belsomra (suvorexant), the first orexin receptor antagonist for insomnia.
A double-blind, placebo-controlled study of lemborexant was published in the Journal of Clinical Sleep Medicine in 2017. Funded and performed by Eisai, the study involved 291 adults with insomnia disorder.
Results support the effectiveness of doses from 2.5 mg to 10 mg. Lemborexant had a positive effect on sleep efficiency by reducing latency to persistent sleep and by decreasing wake after sleep onset. During the 8-hour sleep opportunity, participants treated with lemborexant slept an average of 24 to 48 minutes longer than those who received placebo.
In 2017 the AASM published its first clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults. The guideline emphasizes that medications for chronic insomnia disorder should be considered mainly in patients who are unable to participate in cognitive behavioral therapy for insomnia (CBT-I), patients who still have symptoms after this therapy, or those who require a temporary adjunct to CBT-I.