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Merck insomnia drug approved by FDA
August 14th, 2014
WHITEHOUSE STATION, N.J. – Merck has received approval from the Food and Drug Administration for Belsomra, a medication for adults with insomnia.
The drug maker said late Wednesday that Belsomra (suvorexant) is indicated for the treatment of insomnia characterized by difficulty with falling asleep and/or staying asleep.
Belsomra is expected to be available in late 2014 or early 2015, according to Merck.
The recommended dose of Belsomra is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least seven hours remaining before the planned time of awakening. The total dose should not exceed 20 mg once daily.
"Today's approval of Belsomra allows for the introduction of a new treatment option for patients suffering from insomnia," stated David Michelson, vice president of neurosciences for Merck Research Laboratories. "Belsomra is the result of more than a decade of Merck research in neuroscience and provides tangible evidence of our long-standing commitment to innovation."
Merck said the FDA has recommended that Belsomra be classified by the Drug Enforcement Administration (DEA) as a scheduled product. Earlier this year, the DEA proposed a Schedule IV drug classification under the Controlled Substances Act. According to the company, the DEA has not yet issued a final decision on the scheduling for Belsomra, and therefore the product cannot become available before that decision.