FDA approves new insomnia drug


FDA has approved suvorexant (Belsomra, Merck) for adults with insomnia who have difficulty falling asleep and/or staying asleep.

FDA has approved suvorexant (Belsomra, Merck) for adults with insomnia who have difficulty falling asleep and/or staying asleep.

Insomnia affects 1 in 10 Americans (approximately 30 million Americans) and remains a significant medical problem.

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Belsomra is a highly selective antagonist for orexin receptors. Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake. The mechanism by which Belsomra exerts its therapeutic effect is presumed to be through antagonism of orexin receptors.

“Belsomra has a different mechanism of action from currently approved sleep medicines and, we believe Belsomra will be an important alternative to therapies currently on the market,” according to Pamela Eisele, Merck spokeswoman.

According to GlobalData, the drug is expected to address key insomnia therapeutics market needs, including demand for products with improved tolerability,

Belsomra is expected to be available in late 2014 or early 2015, based on the assumption that the Drug Enforcement Administration (DEA) will issue a final decision on the scheduling for Belsomra by this time. The product cannot be made available until this process is complete. FDA has recommended Belsomra be classified as a scheduled product. Earlier this year, the DEA proposed a Schedule IV drug classification under the Controlled Substances Act.

In clinical trials to support Belsomra’s efficacy, it was superior to placebo for sleep latency and sleep maintenance as assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency. Recommended dose of Belsomra is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. The total dose should not exceed 20 mg once daily. The most common adverse reaction (reported in 5% or more of patients treated with 15  mg or 20 mg of Belsomra and at least twice the placebo rate) was somnolence (Belsomra 6.7%; placebo 3.0%).

Belsomra is contraindicated in patients with narcolepsy. The drug can impair daytime wakefulness and impair driving skills and may increase the risk of falling asleep while driving. Central nervous system (CNS) depressant effects can last for up to several days after discontinuation.

Coadministration with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Patients should be advised not to consume alcohol in combination with Belsomra because of additive effects. Dosage adjustments of Belsomra and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. Use of Belsomra with other drugs to treat insomnia is not recommended.

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