Merck sleeping pill Belsomra gets FDA approval
- The FDA has approved Merck's Belsomra (suvorexant) for treating insomnia. The agency green lighted 5-, 10-, 15-, and 20-mg doses of the drug after rejecting stronger versions last year.
- Unlike other sleeping pills, Belsomra acts directly on orexin receptors in the brain that regulate the sleep-wake cycle.
- Bloomberg analysts estimate that Belsomra could surpass $305 million in sales in 2017.
What sets Belsomra apart from current popular sleep medications such as Sanofi's blockbuster Ambien is the way it interacts chemically with users. Ambien and similar sleeping pills are essentially sedatives that wind down brain activity; by contrast, Belsomra is the first approved sleep aid to directly affect the neuroreceptors that control sleep-wake cycle.
While Belsomra carries some of the same possible side effects as Ambien and Lunesta, its unique chemical mechanism has raised hopes of a pill with less potential downside.
Health officials warned that users should avoid the strongest versions of the drug is possible. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness,” said Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, in a statement.