WASHINGTON — Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.
The Food and Drug Administration on Monday released its review of the company’s sleep aid, suvorexant, ahead of a public meeting on Wednesday. The pill works by temporarily blocking chemical messengers that keep people awake.
The FDA said company trials show suvorexant is better than placebo at helping people fall asleep and stay asleep. And regulators said the drug’s effectiveness was consistent across several doses tested by Merck & Co. Inc.
But patients taking the higher doses of the drug 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.