Merck & Co. Receives FDA Approval for Insomnia Drug Belsomra

The US Food and Drug Administration has approved Merck & Co.’s Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

Belsomra 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. Belsomra alters the signaling action of orexin in the brain.

The FDA has approved Belsomra in four different strengths: 5, 10, 15, and 20 milligrams. The FDA asked Merck 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. FDA advised that patients using the 20-mg strength should be cautioned against next-day driving or activities requiring full mental alertness. The FDA also advised 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.

In June 2013, Merck received a Complete Response Letter (CRL) from the FDA for suvorexant concerning various dosing strengths. In the CRL, the FDA advised that the 10 mg should be the starting dose for most patients and must be available before suvorexant could be approved, and that the 15-mg and 20-mg doses would be appropriate in patients in whom the 10-mg dose was well-tolerated but not effective. For patients taking concomitant moderate CYP3A4 inhibitors, the FDA advised in its CRL that a 5-mg dose would be necessary. In addition, the FDA determined that the safety data did not support the approval of suvorexant in 30 mg and 40 mg doses. In April 2014, the FDA accepted the company's resubmitted new drug application.

The FDA has recommended that Belsomra be classified by the US Drug Enforcement Administration (DEA) as a scheduled product. Earlier this year, the DEA proposed a Schedule IV drug classification under the Controlled Substances Act. The DEA has not yet issued a final decision on the scheduling for Belsomra, and, therefore, the product cannot become available before that decision. The drug is expected to be available in late 2014 or early 2015.

Source: FDA  and Merck & Co.

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