FDA Panel Backs Merck & Co., Inc. Insomnia Drug Suvorexant, But at Lower Doses

Published: May 23, 2013

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The U.S. Food and Drug Administration advisory committee has Wednesday found clear evidence that healthcare giant Merck & Co., Inc.'s (MRK: Quote) blockbuster drug candidate suvorexant is quite effective in promoting sleep, but multiple safety issues call for lower doses. The FDA's peripheral and central nervous system advisory committee reportedly agreed that the drug was generally safe and effective for treating sleep maintenance and latency. The panel voted 13-3, recommending lower starting doses of 15 mg for elderly and 20 mg for non-elderly. The panel delivered a split recommendation, seven for and eight against, on the safety of the higher doses of the product.

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