Merck's Belsomra For Insomnia Gets FDA Nod Of Approval

Merck reported the U.S. Food and Drug Administration’s (FDA) approval of its drug Belsomra (suvorexant) for the treatment of adults with insomnia.

Belsomra is a selective orexin receptor antagonist. Orexin is a neurotransmitter in a particular part of the brain involved in the regulation of the sleep-wake cycle and helps promote wakefulness in people. Belsomra influences and alters the signaling action of orexin in the brain.

Dr. David Michelson, VP of Neurosciences at Merck Research Laboratories, said, “Today’s approval of Belsomra allows for the introduction of a new treatment option for patients suffering from insomnia.” The approval was based on the drug’s superior performance to placebo in sleep latency and maintenance in three clinical trials that investigated its efficacy and enrolled over 500 participants. Results show that patients who took Belsomra spent less time being awake during the night compared to those who took placebo.

Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said, “To assist health care professionals and patients in finding the best dose to treat each individual patient’s sleeplessness, the FDA has approved Belsomra in four different strengths – 5, 10, 15, and 20 milligrams. Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.” In an FDA-requested study, patients who used the maximum recommended strength of Belsomra showed impaired driving performance the next day, which led to the inclusion of cautionary warnings in a Medication Guide for patients taking Belsomra.

Due to the drug’s potential for abuse and dependency, the FDA has recommended Belsomra as a scheduled controlled product to the U.S. Drug Enforcement Administration (DEA). The DEA has proposed a Schedule IV drug classification for the drug earlier this year. The company is awaiting the final decision from the DEA before commercially releasing Belsomra by the end of 2014 or 2015.