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FDA Approves New Type of Sleep Drug, Belsomra (Suvorexant)

Orexin receptor antagonist alters brain signaling

The FDA has approved Belsomra (suvorexant) for use as needed to treat insomnia.

Suvorexant is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Suvorexant alters the signaling of orexin in the brain.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble with attentiveness, learning, and memory.

“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,” said Ellis Unger, MD, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of waking. The total dosage should not exceed 20 mg once daily.

Drowsiness was the most commonly reported adverse event reported by participants in clinical trials of suvorexant. Medications that treat insomnia can cause next-day drowsiness and can impair driving and other activities that require alertness. People can be impaired even when they feel fully awake.

The FDA asked the drug manufacturer (Merck, Sharpe & Dohme Corp.) to study next-day driving performance in people who had taken Belsomra. The testing showed impaired driving performance in both male and female participants when the 20-mg strength was taken. Patients using the 20-mg strength should be cautioned against next-day driving or activities requiring full mental alertness. 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.

The effectiveness of suvorexant was studied in three clinical trials involving more than 500 participants. In these studies, patients taking the drug fell asleep faster and spent less time awake during the remainder of the night compared with subjects taking an inactive pill (placebo). Suvorexant was not compared with other drugs approved to treat insomnia, so it is not known whether there are differences in safety or effectiveness between suvorexant and other insomnia medications.

Like other sleep medications, there is a risk from suvorexant of sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy. Patients or their families should call the prescribing health care professional if this type of activity occurs.

Belsomra (suvorexant) will be dispensed with an FDA-approved patient medication guide that provides instructions for its use and important safety information. Belsomra is a controlled substance (schedule IV) because it can be abused or lead to dependence.

Source: FDA; August 13, 2014.

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