FDA Strengthens Warnings on Sleep Drugs

Yael Waknine

March 15, 2007

March 15, 2007 — Manufacturers of 13 sedative-hypnotic drugs have been asked to strengthen safety label warnings regarding adverse events associated with their use, the US Food and Drug Administration (FDA) announced yesterday. The drugs are used in the treatment of insomnia.

The request, issued in December 2006, addresses the risk for engaging in activities while somnolent with no memory of having taken a pill, according to an alert sent Wednesday from MedWatch, the FDA's safety information and adverse event reporting program. Requested label changes also emphasize the risks for anaphylaxis and angioedema, which can occur the first time the drug is taken.

The FDA notes that sleep behaviors while taking these drugs can be complex and may include sleep-driving, making phone calls, and preparing/eating meals. Because of potential variations in risk levels, makers have also been advised to conduct clinical investigations to assess event incidence rates for each individual product.

Along with these label changes, the FDA also asked manufacturers to develop patient medication guides for distribution with each prescription. These easy-to-read pamphlets are intended to inform patients of the risks associated with therapy and that appropriate precautions that should be taken, such as avoiding alcohol and contacting their physician before discontinuing therapy.

Affected products include zolpidem tartrate tablets and extended-release tablets ( Ambien and Ambien CR , Sanofi-Aventis); butisol sodium (Medpointe Pharm HLC); pentobarbital/carbromal ( Carbitral , Parke-Davis); flurazepam HCl capsules ( Dalmane , Valeant Pharm); quazepam tablets ( Doral , Questcor Pharms); and triazolam tablets ( Halcion , Pfizer).

Also included are eszopiclone tablets ( Lunesta , Sepracor); ethchlorvynol capsules ( Placidyl , Abbott); estazolam ( Prosom , Abbott); temazepam capsules ( Restoril , Tyco Healthcare); ramelteon tablets ( Rozerem , Takeda); seconal sodium capsules (Ranbaxy); and zaleplon capsules ( Sonata , King Pharmaceuticals).

Adverse events potentially related to use of these sedative-hypnotic products should be reported to the manufacturer and to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 


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