Merck has received approval from the US Food and Drug Administration (FDA) for its Belsomra (suvorexant) to treat insomnia in adults having difficulty falling asleep and/or staying asleep.
Belsomra is a selective antagonist for receptors of orexin, which is a neurotransmitter present in a specific part of the brain that helps people remain awake.
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Merck Research Laboratories neurosciences vice-president Dr David Michelson said: "Today’s approval of Belsomra allows for the introduction of a new treatment option for patients suffering from insomnia.
"Belsomra is the result of more than a decade of Merck research in neuroscience and provides tangible evidence of our long-standing commitment to innovation."
Belsomra was found to be superior to a placebo for sleep latency and sleep maintenance during the clinical trials performed to support efficacy.
The drug was assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency.
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By GlobalDataFDA recommended the US Drug Enforcement Administration (DEA) to classify Belsomra as a scheduled product.
The DEA is yet to release a final decision on the scheduling for Belsomra; the product is expected to be available later this year or in early 2015, after DEA issues its decision.
The recommended dose of suvorexant is 10mg, which should be taken 30 minutes before going to bed.
Merck, which is known as MSD outside the US and Canada, noted that the total dose should not exceed 20mg once daily.
