News April 2007
FDA Approved First Generic Versions Of The Sleep Aid Ambien
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.
In 2006, Ambien was the 13th best selling brand name drug, according
to the online magazine Drug Topics. "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. Thirteen manufacturers have received FDA approval
to manufacture zolpidem tartrate tablets.
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.
The sanofi-aventis (formerly Sanofi-Synthelabo Inc.) patent for
zolpidem tartrate expired on April 21, the FDA said.
Source: foxnews
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