Eisai’s Dayvigo Earns FDA Approval for Insomnia

The FDA granted approval to Eisai’s Dayvigo (lemborexant) 5mg and 10mg for the treatment of insomnia in adults.

The approval was based on positive results from two phase 3 studies of Dayvigo versus placebo for up to one month, followed by six months.

As part of the approval, the agency recommended to the Drug Enforcement Administration that the drug be classified as a controlled substance.