FDA Panel Backs Experimental Merck Insomnia Drug
A federal panel of medical experts says that an experimental insomnia drug from Merck & Co Inc. appears safe and effective, despite evidence from company trials that the pill can cause daytime sleepiness and difficulty driving.
A majority of panelists on the Food and Drug Administration panel voted that Merck’s sleeping aid, suvorexant, helped patients get to sleep and stay asleep. In a separate set of votes, the same panel voted that the drug appeared safe at the starting doses proposed by the company.
The FDA’s outside advisers appeared to be somewhat at odds with the agency’s own scientists, who issued a negative review of the drug earlier in the week. The agency noted on Monday that suvorexant was associated with daytime drowsiness, driving difficulties and suicidal thinking.
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