The U.S. Food and Drug Administration said on Wednesday it has approved a first-in-class insomnia drug made by Merck & Co.
The FDA approved the drug, suvorexant (Belsomra) in 5, 10, 15 and 20 milligram doses. Belsomra has the potential to cause next-day sleepiness and impaired driving. Because of this, the FDA said no more than one pill should be taken per night and the dose should not exceed 20 milligrams.
A test conducted by Merck to study the next-day driving performance of people who took the drug showed impaired driving in patients who took 20 milligrams of the drug. Patients therefore “should be cautioned against next-day driving or activities requiring full mental alertness,” the FDA said in a statement.
FDA officials said there was little evidence to show the drug was more effective at higher doses, and considerable evidence to show it was less safe.
“Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness,” said Dr. Ellis Unger, an official in the FDA’s drugs division. www.psychcongress.com 8/15/14