People with the sleep disorder insomnia now have access to a new treatment option after the FDA approved Merck & Co’s Belsomra.
The drug, which contains the active ingredient suvorexant, is the first medicine approved in the US that affects the signalling action of orexin, a brain chemical involved in regulating a person’s sleep cycle.
The approval covers all types of insomnia, which can range from mild to severe and is defined by an individual’s trouble in falling or staying asleep.
To cover the varying severity of the disorder, Belsomra is available in four different strengths – 5mg, 10mg, 15mg and 20mg.
The drug should be taken no more than once per night and with at least seven hours remaining before the planned time of waking in order to reduce the risk of drowsiness during morning activities, such as driving. Indeed, the FDA recommends anyone on the highest does should be cautioned against next-day driving or activities requiring full mental alertness.
Dr David Michelson, VP, neurosciences, Merck Research Laboratories, commendted: “Belsomra is the result of more than a decade of Merck research in neuroscience and provides tangible evidence of our long-standing commitment to innovation.”
This research included three clinical trials involving more than 500 participants during which patients taking Belsomra fell asleep faster and spent less time awake during the remainder of the night compared to people taking placebo.