Zolpidem Tartrate

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Generic Ambien

The FDA approved on the April 23, 2007 the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. It is said that 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.

So, Ambien is brand name for Zolpidem tartrate, a sedative-hypnotic drug used for the short-term treatment of insomnia.

According to the online magazine Drug Topics Ambien was the 13th best selling brand name drug in 2006. "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.

The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals, TEVA Pharmaceuticals USA, Roxane Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddy’s Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical Company, Caraco Pharmaceutical Laboratories, Carlsbad Technology, and Lek Pharmaceuticals.