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September 7, 2005
First and Only Extended-Release Prescription Sleep Medication Indicated for Sleep Induction and Maintenance Covers Broad Insomnia Population
BRIDGEWATER, N.J., Sept. 6 /PRNewswire-FirstCall/ -- Sanofi-aventis (NYSE: SNY; EURONEXT: SAN) announced today that the U.S. Food and Drug Administration (FDA) has approved AMBIEN CR(TM) (zolpidem tartrate extended-release tablets) CIV, a new extended-release formulation of the
number one prescription sleep aid, AMBIEN(R) (zolpidem tartrate) CIV, 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.
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.
"Insomnia is a significant public health problem, affecting millions of
Americans. Insomnia impacts daily activities and is associated with increased
health care costs," said James K. Walsh, PhD, Executive Director and Senior
Scientist, Sleep Medicine and Research Center at St. Luke's Hospital in St.
Louis, Missouri.
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. Additionally, 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.
"Helping patients stay asleep is recognized as being as important as
helping them fall asleep," said Walsh. "AMBIEN CR has shown evidence of
promoting sleep onset and 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 will be 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://www.ambien.com.
About sanofi-aventis
The sanofi-aventis Group is the world's third largest pharmaceutical
company, ranking number one 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
SOURCE sanofi-aventis
Web Site: http://www.sanofi-aventis.com
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