FDA approves new insomnia drug

The U.S. Food and Drug Administration approved Belsomra (suvorexant) tablets for use as needed to treat insomnia.

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Belsomra is an orexin receptor antagonist and is the first approved drug of this type. The effectiveness of Belsomra was studied in three clinical trials involving more than 500 participants.

“To assist healthcare professionals and patients in finding the best dose to treat each individual patient’s sleeplessness, the FDA has approved Belsomra in four different strengths — five, 10, 15, and 20 milligrams,” said Ellis Unger, MD, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

Merck, Sharpe & Dohme manufactured the drug.

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