First-in-Class Insomnia Drug Launches in the United States

Merck has announced the US launch of its insomnia medication, suvorexant (Belsomra), an orexin receptor antagonist indicated for the treatment of adults who have difficulty falling or staying asleep.

Belsomra was approved by the FDA in August 2014. The first and only drug in its class to receive the FDA’s nod, Belsomra works by blocking the reception of a neurotransmitter associated with wakefulness.

“Insomnia is a serious condition that affects millions of Americans,” said David Cloud, CEO of the National Sleep Foundation, in a press release. “With Belsomra, health care professionals and patients now have an additional option to consider.”

“Merck has been conducting research in the sleep field for more than a decade,” added David Michelson, MD, vice president of neurosciences for Merck Research Laboratories. “We are proud to be one of the earliest companies to research the role of orexin receptors in insomnia, which ultimately led to the introduction of Belsomra in the United States.”

Belsomra is now available in 5 mg, 10 mg, 15 mg, and 20 mg tablets. The drug’s active ingredient, suvorexant, is a Schedule IV controlled substance.