Merck releases insomnia drug in US
pharmafile | February 4, 2015 | News story | Sales and Marketing | FDA, Merck, belsomra, insomnia, orexin, suvorexant
Merck’s insomnia drug Belsomra is now available in the US to treat patients who have difficulty falling asleep or staying awake.
Belsomra (suvorexant) is the only orexin – one of the many neurotransmitters in the brain involved in promoting wakefulness – receptor antagonist approved for the treatment of insomnia in the US.
The treatment was approved by the US Food and Drug Administration (FDA) back in August 2014, and selectively blocks these receptors and in doing so is thought to suppress wake drive in the brain.
“Insomnia is a serious condition that affects millions of Americans,” says David Cloud, who is the chief executive of the National Sleep Foundation. “With Belsomra, healthcare professionals and patients now have an additional option to consider.”
The safety and effectiveness of Belsomra was studied in three clinical trials involving more than 500 participants. It was found that patients fell asleep faster and for longer after using the drug compared to whose treated with a placebo.
The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness, but was not compared to other drugs approved to treat insomnia. It is not known if there are differences in safety or effectiveness between Merck’s treatment and other insomnia medications.
“Merck has been conducting research in the sleep field for more than a decade,” comments Dr David Michelson, who is the vice president of Neurosciences at Merck’s 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 US.”
Insomnia is common and can range from mild to severe, depending on how often it occurs and for how long. According to the American Academy of Sleep Medicine nearly one in 10 people have chronic insomnia – a lack of sleep lasting more than three weeks.
Tom Robinson
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