Ambien CR
zolpidem
Treatment for InsomniaFDA Issues Approvable Letter for Ambien CR (Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia
PARIS, April 11, 2005 -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) 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, the world's leading sleep aid1.
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.
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
For full prescribing information, please visit www.ambien.com
Reference:
- IMS Health, National Prescription Audit Plus, MAT December 2003.
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