Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved AMBIEN CR™ (zolpidem tartrate extended-release tablets) CIV, a new extended-release formulation of the number one prescription sleep aid, AMBIEN® (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.
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.