April 23, 2007 — The FDA today approved the first generic versions of
Ambien (zolpidem tartrate) immediate-release tablets.
Zolpidem tartrate is a sedative-hypnotic drug used for the short-term
treatment of insomnia.
“The FDAs Office of Generic Drugs ensures that generic drugs are safe
and effective for the American public through a rigorous scientific and
regulatory process,” the FDA’s Gary J. Buehler, RPh, says in an FDA news
release.
“This approval offers Americans more alternatives when choosing their
prescription drugs,” says Buehler, who directs the FDA’s Office of Generic
Drugs.
Zolpidem tartrate tablets in formulations of 5 milligrams and 10 milligrams
are made by multiple generic drug companies in the U.S.
The following 13 manufacturers have received FDA approval for zolpidem
tartrate tablets: Mylan Pharmaceuticals, TEVA Pharmaceuticals USA, Roxane
Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddys
Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical
Company, Caraco Pharmaceutical Laboratories, Carlsbad Technology, and Lek
Pharmaceuticals.
In March, the FDA requested that all makers 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.
Generic versions of these drugs will also include this labeling.
Ambien is made by Sanofi Aventis. The company’s patent for zolpidem tartrate
expired on April 21, 2007, according to the FDA. Sanofi Aventis’
extended-release Ambien CR isn‘t available in generic versions.

source