The FDA has approved the first generic versions of Ambien (Zolpidem Tartrate) for the short-term treatment of insomnia.
“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 J. Buehler, director, Office of Generic Drugs. “This approval offers Americans more alternatives when choosing their prescription drugs.”
Zolpidem tartrate tablets in formulations of five milligrams and 10 milligrams are manufactured by multiple generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy’s Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.
In March, 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 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. For more information see www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html. Generic versions of these drugs will also include this labeling.
The contents of this post are for informational purposes only and should not be construed as medical advice or substitute for professional health care. I’m not a medical doctor, so I do not give medical advice. For medical emergencies seek immediate medical attention!
[tags] FDA, Ambien, Zolpidem Tartrate, Insomnia, health, drugs, pills, medicine, pill, sleeping pill, sleeping pills, sleeping drug, sleep[/tags]