FDA accepts Merck application for insomnia drug

Suvorexant to receive review for controlled substance scheduling

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

Merck announced the the FDA's acceptance of its regulatory filing for suvorexant, which the FDA's Controlled Substances Staff will review while the agency is reviewing the application.

"The discovery and development of innovative medicines that help patients is our goal at Merck, and insomnia is a common disorder where patients are seeking new treatments," Merck Research Labs SVP and franchise head for neuroscience and ophthalmology Darryle Schoepp said. "Suvorexant is a novel mechanism for the treatment of insomnia, and the filing of suvorexant is a novel mechanism for the treatment of insomnia, and the filing of suvorexant is an example of Merck's commitment to patients and to scientific excellence."


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