Merck announces US availability of BELSOMRA (suvorexant) for treatment of insomnia

Feb 4 2015

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that BELSOMRA^® (suvorexant) is now available at pharmacies in the United States for the treatment of insomnia in adults who have difficulty falling asleep and/or staying asleep. BELSOMRA is the only orexin receptor antagonist approved for the treatment of insomnia in the United States. Orexin is one of the many neurotransmitters in the brain involved in promoting wakefulness, and BELSOMRA selectively blocks orexin receptors. In doing this, BELSOMRA is thought to suppress wake drive in the brain.

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

The recommended dose of BELSOMRA is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. The total dose should not exceed 20 mg once daily.

BELSOMRA is contraindicated in patients with narcolepsy. BELSOMRA contains suvorexant, a Schedule IV controlled substance. BELSOMRA can impair daytime wakefulness. Central nervous system (CNS) depressant effects can last for up to several days after discontinuation.

In the brain’s wake/sleep circuitry, two systems work together to regulate wake and sleep. The system that is more active determines whether a person is awake or asleep. The orexin signaling system is a central promoter of wakefulness. Scientists currently at Tsukuba University, Kanazawa University in Japan, and Stanford University in the United States first discovered orexin in 1998.

“Merck has been conducting research in the sleep field for more than a decade,” said Dr. David Michelson, vice president, Neurosciences, 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.”

Patients with insomnia should ask their healthcare providers about BELSOMRA. BELSOMRA is available in 5 mg, 10 mg, 15 mg, and 20 mg tablets. Healthcare professionals and patients in the United States can visit www.belsomra.com to learn more.

Merck is also developing a broad range of resources for patients to help educate them about insomnia and encourage dialogue with their healthcare providers. More information will be available in March 2015.

Source: http://www.merck.com/