FDA Approves Novel Insomnia Drug

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

Suvorexant tablets (marketed as Belsomra) have been approved to treat insomnia, the FDA announced on Wednesday. The drug is the first approved orexin receptor antagonist — orexin helps regulate wakefulness.

Like other sleep aids, Suvorexant is a Schedule-IV controlled substance, as it may lead to dependence. In addition, it carries a risk for behaviors such as driving, eating, having sex, and making phone calls while not fully awake. It will be available in 5-, 10-, 15- and 20-mg doses; the lower the dose, the lower the risk for common side effects like next-day drowsiness. Patients should not take more than 20 mg per day.

The approval is based on data from three randomized trials of some 500 total patients. Those who took suvorexant fell asleep faster and woke up less during the night than those given placebo.