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

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments