Merck Insomnia Drug Safer at Lower Dose, FDA Staff Says

Merck & Co.’s experimental insomnia drug, designed to turn off wakefulness rather than subdue the brain into slumber like Ambien, may only be safe at lower doses than what the company has proposed, U.S. regulators said.

Doses that Merck studied of as much as 40 milligrams of the drug suvorexant, while effective in helping the sleep deprived, may not be safe, Food and Drug Administration staff said today in a report. Lower doses may work just as well with better safety, but more information may be needed, the staff said.