The Food and Drug Administration (FDA) has approved Dayvigo (lemborexant; Eisai) for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.

The approval of Dayvigo, an orexin receptor antagonist, was based on data from two phase 3 studies (SUNRISE 1 and SUNRISE 2) that enrolled approximately 2000 patients. In SUNRISE 1, lemborexant achieved its primary and key secondary objectives (change from baseline in both sleep onset and sleep maintenance variables using objective polysomnography) vs placebo and vs zolpidem tartrate extended-release (active comparator) in patients aged ≥55 years with insomnia disorder.

In SUNRISE 2, treatment with lemborexant 5mg and 10mg resulted in a statistically significant improvement in subjective sleep onset latency vs placebo (primary end point), as assessed by patient sleep diaries. Both doses of lemborexant also led to a statistically significant improvement in sleep maintenance variables of subjective sleep efficiency and subjective wake after sleep onset vs placebo (key secondary end points).

With regard to safety, the most common adverse reaction observed in both studies was somnolence.

“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 6-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 with insomnia.

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In addition to the 2 pivotal trials, the Company conducted specialty safety studies to evaluate middle of the night safety, next-day postural stability and memory, effects on driving, rebound insomnia and withdrawal effects with Dayvigo. Based on study results, patients should be cautioned about the potential for middle of the night postural instability, as well as attention and memory impairment. Moreover, patients using the 10mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to Dayvigo.

Dayvigo will be available in 5mg and 10mg tablets following scheduling by the US Drug Enforcement Administration (DEA), which is expected to occur within 90 days.

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