Published on April 11, 2005 at 4:02 PM
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) CIV. Ambien CR is the controlled-release formulation of zolpidem, a 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(TM) and are not related to the safety and efficacy of Ambien (zolpidem tartrate).
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.
For full prescribing information, please visit http://www.Ambien.com/.
http://www.sanofi-synthelabo.us/