From Pharmacy Drug Guide
Suvorexant is an investigational prescription sleep medication that is being developed by Merck & Co. A Phase 3 study of Suvorexant was completed in November 2011, with results reported in September 2012. The next step ion the Suvorexant approval process will be the submission of a NDA to the FDA.
Suvorexant will be part of a new class of medications called orexin receptor antagonists. Traditional sleeping medications such as Ambien® and Lunesta®, work by binding to GABA receptors, and slowing down the activity of neurons in the brain, creating a sedating effect. Suvorexant, in contrast, works by turning off wakefulness rather than by inducing sleep. Suvorexant targets and blocks orexins, messenger chemicals that come from the hypothalamus, a key sleep center in the brain, that help keep people awake.
|Approval stage||Phase 3 trials complete|
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Suvorexant Approval Process
In September 2012, the pharmaceutical company Merck released new data for Suvorexant, its investigational new insomnia drug. The Suvorexant study was one of the longest trials of a sleep medication ever conducted. The 12-month study assessed Suvorexant's safety and long-term efficacy. In the first month of the study, patients taking Suvorexant reported falling asleep significantly faster, staying asleep longer compared to patients who were given a placebo. 
Merck intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration FDA in 2012. In addition to the regular FDA approval process, Merck anticipates that Suvorexant will be evaluated by the Controlled Substance Staff of the FDA. If classified as a controlled substance by the FDA, Suvorexant would also require DEA review before being brought to market.
Suvorexant Side Effects
The most common side effects noted during the first 12 months of Suvorexant treatment were drowsiness and fatigue, as well as upper respiratory symptoms such as congestion, infection, and dry mouth. 69.5 percent of those who took Suvorexant experienced one or more adverse effects compared to versus 63.6 percent of those who received the placebo.
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