- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Advisors Back New Sleep Drug, Suvorexant
Daytime somnolence is a concern (May 22)
By a 13-to-3 vote, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has recommended approval of the investigational insomnia drug suvorexant (Merck).
Members of the panel expressed concern, however, about the potential for daytime somnolence at doses of 30 and 40 mg. The panel voted 13 to 3, with one abstention, that suvorexant could be used safely at the maximum doses of 15 mg for elderly patients and 20 mg for non-elderly patients. They also narrowly agreed — by a vote of 8 to 7, with two abstentions — that the drug is not safe at 30 and 40 mg.
The panel voted unanimously (16 to 0) that suvorexant is effective in inducing sleep.
If approved, the drug would be the first in a new class of medicines called orexin receptor antagonists for use in patients with insomnia. Suvorexant was developed to temporarily block the action of orexins, neurotransmitters in a specific part of the brain that help to keep a person awake.
The FDA will consider the committee’s recommendations as it completes its review of the new drug application (NDA) for suvorexant. The agency is not bound by the committee’s guidance but takes its advice into consideration when reviewing investigational medicines.