Merck's Belsomra gets FDA approval for insomnia

US Pharma giant Merck & Co (NYSE: MRK) has received US Food and Drug Administration approval for its insomnia treatment Belsomra (suvorexant) for adults. It is a selective antagonist for orexin receptors, which work to combat orexin, a neurotransmitter that can help keep a person awake.

In the trials to support its efficacy, it was superior to placebo for sleep latency and maintenance as assessed by polysomnography and patient-estimated sleep latency.

The FDA has recommended Belsomra to be classified as a scheduled product by the US Drug Enforcement Administration, which earlier this year proposed a Schedule IV drug classification under the Controlled Substances Act. It has not yet issued a final decision on the scheduling for Belsomra, and the product cannot be brought to market before then.