FDA Okays Generic Zolpidem

ROCKVILLE, Md., April 25 -- The FDA has approved the first generic versions of zolpidem tartrate, marketed for years as Ambien, for short-term treatment of insomnia.

The patent on Ambien, sold by sanofi-aventis, expired on April 21. Thirteen companies were giver approval to market generics.

The FDA said the generics will be marketed in 5 mg and 10 mg tablets and will be required to carry a warning about risks that include severe allergic reactions and complex sleep-related behaviors.

These risks include sleep-driving, defined as motoring while not fully awake, with no memory of the event, after taking a sedative-hypnotic product.

In March the sleep-driving warning was added to the labels of Ambien and 12 other sedative-hypnotic drugs.

Last December, the FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the entire class revise product labeling to include warnings about:

• Anaphylaxis and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
• Complex sleep-related behaviors, which may include sleep-driving, making phone calls, and preparing and eating food while asleep.

The companies receiving approval for generic zolpidem tartrate tablets were 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.