Generic Ambien Approved By FDA

Published: Apr. 23, 2007 at 8:23 PM CDT|Updated: Mar. 2, 2010 at 7:35 PM CST
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The U.S. Food and Drug Administration approved Monday the first generic versions of the sleep aid Ambien -- generic name zolpidem tartrate. It's a sedative-hypnotic drug indicated for the short-term treatment of insomnia.

"This approval offers Americans more alternatives when choosing their prescription drugs," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.

Zolpidem tartrate tablets in formulations of 5 milligrams and 10 milligrams are manufactured by a variety of generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc.; TEVA Pharmaceuticals USA; Roxane Laboratories Inc.; Watson Laboratories Inc.; Ranbaxy Laboratories Ltd.; Dr. Reddys Laboratories Ltd.; Apotex Inc.; Synthon Pharmaceuticals Inc.; Genpharm Inc.; Mutual Pharmaceutical Company Inc.; Caraco Pharmaceutical Laboratories Ltd.; Carlsbad Technology Inc.; and Lek Pharmaceuticals, the FDA said in a statement.

In March, the FDA requested that all manufacturers of sedative-hypnotic drug products -- a class of drugs used to induce and/or maintain sleep -- strengthen their product labeling to include stronger warnings about potential risks. Those risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after taking a sedative-hypnotic drug, with no memory of the event.

According to the online magazine Drug Topics, in 2006, Ambien was the 13th best selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, the FDA said.