FDA reviewing Merck's experimental insomnia drug

by The Associated Press

(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.

also plans to seek approval for suvorexant in other countries.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA won't accept Merck's application for new drug

Nov 02, 2009

(AP) -- U.S. regulators have refused to accept drugmaker Merck & Co.'s application for a new, combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug.

FDA links some prostate drugs to cancer risk

Jun 09, 2011

(AP) -- The Food and Drug Administration expanded the warning label on a group of prostate drugs Thursday, saying they may increase the risk of a more serious form of prostate cancer.

FDA says Merck drug successfully fights hepatitis

Apr 25, 2011

Federal health officials said Monday a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs that have been used for 20 years. But the agency has questions ...

Recommended for you

FDA to start regulating lab-developed tests

Jul 31, 2014

(AP)—The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

User comments