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Belsomra should be taken once nightly within 30 minutes of going to bed, the FDA said Wednesday in a news release. Approved in four strengths ranging from 5 milligrams to 20 milligrams, Belsomra should be taken at the lowest effective dose to minimize daytime sleepiness and related side effects, the agency said.
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-milligram dose, the FDA said.
As with other sleep medicines, the agency warned that users of Belsomra have the potential for sleep-driving, 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, the FDA said.
"Belsomra is a controlled substance [Schedule-IV] because it can be abused or lead to dependence," the agency added.
-- Scott Roberts
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