FDA Panel Votes on Safety of Merck Sleep Aid Drug Suvorexant

Despite Food and Drug Administration (FDA) experts issuing a negative review of the drug earlier in the day, an FDA panel voted that suvorexant, a sleep aid manufactured by Merck, is effective, and, in a separate vote, that the drug appears safe when used at the recommended dosage.

The FDA is not required to follow in-house recommendations.

Results from Merck’s own company trials, however, show some of the medication’s side effects include suicidal thoughts and impaired driving. FDA researchers cited some of those results in their review, including a man who drove off the road while taking the drug.

Dr. Ronald Farkas, who presented those findings, said with regard to making the drug safer, “How many people are you willing to risk versus how much effort are you willing to make?”