FDA approves Belsomra for insomnia

The US Food and Drug Administration (FDA) has approved Merck’s Belsomra (suvorexant) tablets to treat insomnia.

Belsomra is an orexin receptor antagonist and is the first drug of this type to be approved. Orexins are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signalling of orexin in the brain.

“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 20mg,” said Dr Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

In 2013 the FDA rejected the drug at higher doses, citing safety issues.

Dr David Michelson, vice president, Neurosciences, Merck Research Laboratories, said, “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.”

The drug’s effectiveness was studied in three clinical trials involving more than 500 participants.

Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20mg once daily. It is a Schedule-IV controlled substance because it can be abused or lead to dependence.

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The US FDA rejects approval of Merck’s insomnia drug

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