FDA turns down Merck insomnia drug

Agency cites dosage issues in complete response letter

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

The drug maker said Monday that it received a complete response letter from the FDA concerning the drug suvorexant, for which it is seeking regulatory approval. A complete response letter means that the agency has finished reviewing its approval application, but questions remain that preclude final approval.

The FDA determined that the drug should be available in a 10-mg dosage, and the 15-mg and 20-mg doses should be given to patients if 10 mg isn't enough, but based on clinical data, the agency did not think the 30-mg and 40-mg doses would be safe.

"We will evaluate the requests outlined in the complete response letter and expect thereafter to work expeditiously with the FDA to make suvorexant available as a new treatment option for patients suffering from insomnia," Merck Research Labs president Roger Perlmutter said.


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