FDA Approves Drug for Adult Insomnia

The U.S. Food and Drug Administration (FDA) has approved lemborexant (brand name DAYVIGO™) for the treatment of adult insomnia. The dosage will be prescribed in 5 mg and 10 mg tabs for patients who struggle with falling asleep or maintaining sleep.

According to a press release, "the approval was based on a robust clinical development program that included two pivotal Phase 3 studies, which evaluated DAYVIGO versus placebo for up to one month and DAYVIGO versus placebo for six months."

There are potential risks, however, and a submission was made to the U.S. Drug Enforcement Administration (DEA) that will classify lemborexant as a controlled substance.

Lemborexant will be commercially available as DAYVIGO by manufacturer Eisai Co., Ltd., "following scheduling by the DEA, which is expected to occur within 90 days."