FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia

Published: Mon Apr 23 00:00:00 +0000 2007

The U.S. Food and Drug Administration (FDA) today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedative-hypnotic drug indicated for the short-term treatment of insomnia.

"The FDA’s Office of Generic Drugs ensures that generic drugs are safe and effective for the American public through a rigorous scientific and regulatory process," said Gary J. Buehler, director, Office of Generic Drugs. "This approval offers Americans more alternatives when choosing their prescription drugs."

Zolpidem tartrate tablets in formulations of five milligrams and 10 milligrams are manufactured by multiple 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. Reddy’s Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.

In March, 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 language concerning potential risks. These 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 ingestion of a sedative-hypnotic product, with no memory of the event. For more information see www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html. Generic versions of these drugs will also include this labeling.

According to the online magazine Drug Topics, in 2006, Ambien was the 13th highest selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, 2007.

The FDA’s Office of Generic Drugs (OGD) reviews and decides on approval of generic drug applications. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/.

For more information about generic drugs, please see the FDA Consumer article, Generic Drugs: What You Need to Know at www.fda.gov/fdac/features/2002/502_generic.html. For additional information related to FDA's Office of Generic Drugs, please see: www.fda.gov/cder/consumerinfo/generic_equivalence.htm.