Pivotal Phase III study further demonstrates efficacy of Dayvigo

Japanese pharma major Eisai (TYO: 4523) on Friday announced that JAMA Network Open ( www.jamanetwork.com) published results of SUNRISE 1 (Study 304), a pivotal Phase III head-to-head study that compared its just US-approved Dayvigo (lemborexant) to placebo and an active comparator in patients with insomnia disorder that showed the 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," said Dr Lynn Kramer, chief clinical officer, Neurology Business Group, Eisai, adding: "The study featured in this publication provides insights into why this agent may make an important difference for patients living with insomnia."

Study details

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 5mg or 10mg, 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 5mg, and 4.9% for Dayvigo 10mg) and somnolence (1.9% for placebo, 1.5% for active comparator, 4.1% for Dayvigo 5mg, and 7.1% for Dayvigo 10mg).