AMBIEN CR™ now available in the US
Bridgewater, NJ
October 07, 2005
First and Only Extended-Release Prescription Sleep Medication Indicated for Sleep Induction and Maintenance Now in Pharmacies Across the U.S.

Sanofi-aventis (NYSE: SNY; EURONEXT: SAN) announced today that AMBIEN CR™ (zolpidem tartrate extended-release tablets) CIV, a new extended-release formulation of the number one prescription sleep aid AMBIEN® (zolpidem tartrate) CIV, is now available by prescription in pharmacies across the United States for the treatment of insomnia.  AMBIEN CR™ is non-narcotic and a non-benzodiazepine, formulated to offer a similar safety profile to AMBIEN® with a new indication for sleep maintenance, in addition to sleep induction.  In contrast to AMBIEN®, AMBIEN CR™ is not limited to the short-term treatment of insomnia.

According to a recent National Sleep Foundation poll, more than one half (54%) of Americans said they experience at least one symptom of insomnia at least a few nights a week.  In fact, one in five adults experienced difficulty falling asleep and one in three reported waking often during the night at least a few nights a week.

AMBIEN CR™ is the first and only extended-release prescription sleep medication to help people with insomnia fall asleep fast and maintain sleep with no significant decrease in next day performance. AMBIEN CR™, a bi-layered tablet, is delivered in two stages.  The first layer dissolves quickly to induce sleep. The second layer is released more gradually into the body to help provide more continuous sleep.

The safety and efficacy of zolpidem, the active ingredient in AMBIEN CR™, has been reinforced by 17 years of real-world use and 12 billion nights of patient therapy worldwide, since the first launch.  

AMBIEN CR™ is now available in a 12.5 mg dose recommended for adults and a 6.25 mg dose recommended for the elderly.  

About AMBIEN CR
AMBIEN CR is indicated for the treatment of insomnia.  Until you know how AMBIEN CR will affect you, you shouldn’t drive or operate machinery.  Side effects may include drowsiness, dizziness and headache.  You shouldn’t take it with alcohol.  All sleep medicines carry some risk of dependency.  Do not use sleep medicines for extended periods without first talking to your doctor.  Be sure you are able to devote 7-8 hours of sleep before you need to be active again.  

For full prescribing information, please visit  http://products.sanofi-aventis.us/ambien_cr/ambien_cr.pdf

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, dizziness, and diarrhea.  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://products.sanofi-aventis.us/ambien/ambien.pdf

 

About sanofi-aventis

The 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 diseases, central nervous system, internal medicine, and vaccines.  The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., and Aventis Pharmacuticals Inc. and Sanofi Pasteur Inc.

 

U.S. Contact
Melissa Feltmann, +1 908-243-7080, melissa.feltmann@sanofi-aventis.com.