Zolpidem Tartrate and Ambien

Facts

Ambien and Zolpidem Tartrate are the same. Ambien is just brand name for Zolpidem tartrate, a sedative-hypnotic drug used for the short-term treatment of insomnia.

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.

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.

Tablets

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.

Manufacturers

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.