News from the FDA/CDC

FDA approves Dayvigo for insomnia


 

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.

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.

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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