FDA has safety concerns on Merck insomnia drug

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 released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday. The pill works by temporarily blocking that keep people awake.

The FDA said company trials show suvorexant was better than placebo at helping people fall asleep and stay asleep. Regulators said Monday the drug's effectiveness was consistent across several doses tested by Merck & Co.

But patients taking the highest dose of the drug showed an eight-fold increase in daytime drowsiness, which could interfere with driving the next morning. Suvorexant was also associated with increased risk of suicidal thinking.

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

Related Stories

Is a better sleeping pill on the way?

Apr 03, 2013

(HealthDay)—A new class of sleep medications appears to help people fall asleep without causing grogginess the next day, researchers say.

FDA: lower ambien's dose to prevent drowsy driving

May 15, 2013

(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...

Recommended for you

Xtoro approved for swimmer's ear

15 hours ago

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

16 hours ago

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

Judge halts Alzheimer's drug swap until July

Dec 16, 2014

A federal judge has ordered an Irish drug manufacturer to halt its plans to discontinue its widely used Alzheimer's medication, allegedly in an effort to drive patients to a newer patented drug.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.