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U.S. FDA lowers starting dose of sleep drug Lunesta over safety

Started by riky, May 16, 2014, 09:00:16 AM

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U.S. FDA lowers starting dose of sleep drug Lunesta over safety

(Reuters) - U.S. health regulators on Thursday said they required a label change for the sleep drug Lunesta to cut the recommended starting dose over concerns it could impair alertness in some people the following morning. The Food and Drug Administration said the starting dose for the drug taken at bedtime for both men and women should be the lowest 1 milligram dose, down from the previous 2 mg recommended starting dose. \"To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,\" Ellis Unger, of the FDA's Center for Drug Evaluation and Research, said in a statement.

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