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FDA Review Flags Concerns About Merck’s Insomnia Pill

FDA Review Flags Concerns About Merck's Insomnia Pill
FDA Review Flags Concerns About Merck's Insomnia Pill
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Merck’s Insomnia Pill, Suvorexant

In an unusual move, the FDA has instructed Merck not to offer the 30mg and 40mg sized doses of suvorexant, their proposed new insomnia aid. At the higher doses patients, “showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness.” Reports of suicidal thoughts were also troubling. via NJ.com. Published May 20, 2013

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