US regulators have waved through Eisai’s sleep drug Dayvigo (lemborexant).
Specifically, the drug has been approved for the treatment of adults with insomnia characterised by difficulties with sleep onset and/or sleep maintenance.
Clearance of Dayvigo rides on a clinical development programme that included two pivotal Phase III studies, which provided evidence that it may “improve patients’ ability to fall and stay asleep,” according to the firm.
Eisai also noted that Dayvigo 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”.
The regulator has recommended that the medicine be classified as a controlled substance, and as such it is now awaiting scheduling by the country’s Drug Enforcement Agency.