The US FDA has approved the orexin receptor antagonist Dayvigo (lemborexant) for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults, according to manufacturer Eisai Co Ltd (Tokyo).

The approval was based on the results of a clinical development program that included two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which evaluated Dayvigo versus comparators for up to one month and DAYVIGO versus placebo for six-months.

According to Eisai, the trials found that Dayvigo demonstrated statistically significant superiorities on sleep onset and sleep maintenance compared to placebo in both subjective and objective evaluations.

Across SUNRISE 2 and SUNRISE 1, the drug was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects following discontinuation at either 5 mg or 10 mg doses, Eisai reported.

The most common adverse reaction in SUNRISE 2 (the first 30 days) and SUNRISE 1 was somnolence (Dayvigo 10 mg, 10%; Dayvigo 5 mg, 7%; placebo, 1%).

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

“Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being,” said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the clinical studies and former Chairman of the Board of the National Sleep Foundation. “The clinical trials provide evidence that Dayvigo may improve patients’ ability to fall asleep and stay asleep.”

“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 six-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.”