Belsomra Approved to Treat Insomnia

HealthDay News — The FDA has approved suvorexant (Belsomra), an orexin receptor antagonist, to treat insomnia.

Suvorexant should be taken once nightly within 30 minutes of going to bed, the FDA said in a press release. Approved in four strengths ranging from 5 to 20 mgs, suvorexant should be taken at the lowest effective dose to minimize daytime sleepiness and related side effects.

In clinical studies involving more than 500 participants, the drug’s most common side effect was next-day drowsiness. As a condition of approval, New Jersey-based drug maker Merck, Sharpe & Dohme is required to study next-day driving performance among men and women who took the 20-mg dose, the FDA said.

As with other sleep medicines, the agency warned that users of suvorexant have the potential for sleep-driving, as well as preparing and eating food, making phone calls, or having sex while not fully awake. The risk of these and similar “complex behaviors” increases if the user simultaneously drinks alcohol or takes other medicines that make them sleepy.

“[Suvorexant] is a controlled substance [Schedule-IV] because it can be abused or lead to dependence,” the agency added.

More Information