FDA approves Belsomra tabs

SILVER SPRING, Md. — The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia. The drug works by altering the signaling of orexin in the brain. Orexins are chemicals involved in regulating the sleep-wake cycle and play a role in keeping people awake, the agency stated.

“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 — 5, 10, 15 and 20 mg,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

The drug should only be taken no more than once a night, within 30 minutes of going to bed. The total dose shouldn't exceed 20 mg once daily. Belsomra is produced by Merck, Sharpe & Dohme Corp.

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