FDA Approves First-in-Class Sleep Drug


Belsomra (suvorexant) is the first orexin receptor antagonist approved for insomnia.

The FDA announced today that it has approved Belsomra (suvorexant) tablets for use as needed to treat insomnia.

Belsomra is the first orexin receptor antagonist to receive approval. According to the FDA announcement, orexins are chemicals that “are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.”

Belsomra is approved in four different strengths: 5, 10, 15, and 20 mg. Ellis Unger, MD, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said that “using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

The medication should be taken within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of waking. Belsomra should only be taken once daily, with the total dose not to exceed 20 mg per day.

Approval of Belsomra was based in part on the results of three clinical trials involving more than 500 subjects. Study participants who took the drug fell asleep faster and spent less time awake during the remainder of the night compared to participants who received placebo. The FDA statement noted that “Belsomra was not compared to other drugs approved to treat insomnia, so it is not known if there are differences in safety or effectiveness between Belsomra and other insomnia medications.”

During the clinical trials, the most commonly reported adverse reaction reported by participants who received Belsomra was drowsiness.

The FDA also asked the drug manufacturer, Merck, Sharpe & Dohme Corp., to study next-day driving performance in people who had taken Belsomra. Those test showed impaired driving performance in male and female participants who were treated with Belsomra 20 mg. Patients using the 20 mg strength “should be cautioned against next-day driving or activities requiring full mental alertness.” The FDA cautioned that “patients taking lower doses should also be made aware of the potential for next-day driving impairment, because there is individual variation in sensitivity to the drug.”

Like other sleep medicines, there is a risk from Belsomra of “sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex,” with an increased risk in people who have consumed alcohol or taken other sleep medicines. Patients or their families are advised to call the prescribing health care professional if this type of activity occurs.

Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a Schedule-IV controlled substance.

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