Ambien, also known as zolpidem tartrate, will be available in 5mg and 10 mg doses from: Mylan Pharmaceuticals, Teva Pharmaceuticals, 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.
Ambien, along with other sedative-hypnotics prescribed for sleep disorders, have been linked with side effects including severe allergic reactions and sleep driving. Sleep driving involves a patient driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
“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 Buehler, director of the Office of Generic Drugs. “This approval offers Americans more alternatives when choosing their prescription drugs.”
Zolpidem tartrate tablets had total annual sales of approximately $2.1 billion, according to IMS sales data for 2006.