FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the
Treatment of Insomnia
April 23, 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.
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