FDA Committee Approves New Insomnia Drug

A Food and Drug Administration (FDA) advisory committee has decided that Merck's experimental drug suvorexant is effective against insomnia, but that starting doses should be low—15 mg. for the elderly and 20 mg. for the nonelderly. The FDA will consider the advisory committee's recommendations as it completes its review of Merck's New Drug Application for suvorexant.

If approved, suvorexant would be the first in a new class of medicines called orexin receptor antagonists. Orexins are neurotransmitters in the brain that help keep a person awake. By temporarily blocking the actions of orexins, suvorexant helps facilitate sleep. "We are excited about the potential of suvorexant as a new and different approach to treating insomnia, a serious condition that affects up to one-third of the adult population," Darryle Schoepp, Ph.D., said in a press statement. He is senior vice-president and head of the Neuroscience and Ophthalmology Division of Merck Research Laboratories.

More information about suvorexant can be found in Psychiatric News here. More information about treating insomnia can be found in Psychiatric News here and also in American Psychiatric Publishing's Clinical Manual for Evaluation and Treatment of Sleep Disorders.

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