Sanofi US News

FDA issues approvable letter for AMBIEN CR™ (zolpidem tartrate extended release) C IV for the treatment of Insomnia
Paris, France
Sanofi-aventis announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for AMBIEN CR™ (zolpidem tartrate extended release) C IV.

AMBIEN CR™ is the controlled-release formulation of zolpidem, the world’s leading sleep aid. 

An approvable letter outlines specific questions that have to be resolved before the Agency will approve a product for marketing.

Sanofi-aventis Group is already working closely with the FDA to address the questions outlined in the letter.  The FDA’s questions relate specifically to AMBIEN CR™ and are not related to the safety and efficacy of AMBIEN® (zolpidem tartrate). 


About Ambien

AMBIEN® is indicated for the short-term treatment of insomnia. There is a low occurrence of side effects associated with the short-term use of AMBIEN®. The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%).  When you first start taking AMBIEN®, use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication.  In most instances, memory problems can be avoided if you take AMBIEN® only when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again. As with any sleep medication, do not use alcohol while you are taking AMBIEN®.  Prescription sleep aids are often taken for 7 to 10 days—or longer as advised by your doctor. All people taking sleep medicines have some risk of becoming dependent on the medicine.  

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About sanofi-aventis

Sanofi-aventis Group is the world’s 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

The sanofi-aventis Group conducts business in the U.S. through its affiliates Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.


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U.S. Contact
Melissa Feltmann, 908-243-7080, 


Last update: April 11, 2005