FDA Reviewing Merck's Experimental Insomnia Drug
WHITEHOUSE STATION, N.J. (AP) — Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its experimental insomnia medication, suvorexant (SOO'vor-eks-ant).
The drug minimizes the morning grogginess common with many sleep aids. It could become a big seller for the Whitehouse Station, N.J., company.
If approved, it would be the first in a new class of medicines for patients with trouble falling or staying asleep. It works by temporarily blocking chemical messengers that keep people awake.
The FDA is doing a standard review, which usually takes 10 months. If approved, suvorexant would be a controlled substance like all hypnotic sleep drugs. They require additional government reviews taking four months or longer.
In studies, suvorexant's most common side effects were tiredness and headache.
Merck also plans to seek approval for suvorexant in other countries.