Phase 3 Study: DAYVIGO Improved Sleep Onset, Sleep Maintenance Compared with Placebo0

JAMA Network Open has published results of SUNRISE 1 (Study 304), a pivotal Phase 3 head-to-head study that compared DAYVIGO (lemborexant), marketed by Eisai Inc, to placebo and an active comparator in patients with insomnia disorder. In this study, DAYVIGO therapy significantly improved both sleep onset and sleep maintenance compared with placebo.

“We are pleased to share these important study results in JAMA Network Open,” says Lynn Kramer, MD, chief clinical officer, Neurology Business Group, Eisai, in a release. “The study featured in this publication provides insights into why this agent may make an important difference for patients living with insomnia.”

SUNRISE 1 was a global, randomized, double-blind, placebo-controlled, active comparator parallel-group study of 1,006 adults 55 years of age or older with insomnia disorder receiving DAYVIGO 5 mg or 10 mg, an active comparator or placebo for one month at bedtime. The primary study endpoint was the change from baseline in latency to persistent sleep for DAYVIGO therapy versus placebo. Key secondary endpoints were changes from baseline in sleep efficiency and wake after sleep onset compared with placebo, and wake after sleep onset in the second half of the night compared with the active comparator. Treatment-emergent adverse events reported in ≥2% of participants in any active treatment group included headache (6.2% for placebo, 5.3% for active comparator, 6.4% for DAYVIGO 5 mg, and 4.9% for DAYVIGO 10 mg) and somnolence (1.9% for placebo, 1.5% for active comparator, 4.1% for DAYVIGO 5 mg, and 7.1% for DAYVIGO 10 mg).

DAYVIGO was approved by the U.S. Food and Drug Administration on December 20, 2019 for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The FDA has recommended that DAYVIGO be classified as a controlled substance and this recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA). DAYVIGO will be commercially available following scheduling by the DEA.

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