The Food and Drug Administration (FDA) has approved Belsomra (suvorexant; Merck) tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra has been scheduled as a CIV controlled substance due to its abuse and dependence potential.

Belsomra is the first orexin receptor antagonist approved for insomnia. Belsomra alters the actions of orexin, which are chemicals involved in regulating the sleep-wake cycle.

The efficacy of Belsomra was assessed in three clinical trials involving over 500 patients. Study results showed that those in the Belsomra treatment group fell asleep faster and spent less time awake during the remainder of the night vs. patients in the placebo group.

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Belsomra will be available in 5mg, 10mg, 15mg, and 20mg strength tablets.

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