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FDA panel: Merck's insomnia drug effective, safe at low doses
May 22, 2013 / 8:57 PM / in 5 years

FDA panel: Merck's insomnia drug effective, safe at low doses

WASHINGTON, May 22 (Reuters) - Merck & Co’s experimental insomnia drug is safe and effective at the lower of two doses studied but not at the higher, a panel of medical experts said on Wednesday.

The panel, which advises the U.S. Food and Drug Administration on matters related to central nervous system disorders, voted 13-3, with one abstention, that the drug, suvorexant, is safe for elderly patients at 15 milligrams a day, and is safe for non-elderly adults at 20 milligrams.

The panel voted 8-7, with two abstentions, that the drug is not safe when given to elderly patients at 30 milligrams or non-elderly adults at 40 milligrams.

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