FDA approves Belsomra for Insomnia-Merck Inc.
Merck Inc. announced that the FDA has on 13 August 2014 approved Belsomra (suvorexant) for adults with Insomnia who have difficulty falling asleep and/or staying asleep. 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.
In the clinical trials to support efficacy, Belsomra was superior to placebo for sleep latency and sleep maintenance as assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency. The 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.
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