Healthcare Industry News: sanofi-aventis
News Release - March 20, 2006
Statement Responding to Recent Media Reports Regarding Appropriate Use of AMBIEN(R) (zolpidem tartrate) CIV in the USBRIDGEWATER, N.J., March 20 (HSMN NewsFeed) -- sanofi-aventis (NYSE: SNY; EURONEXT: SAN) is committed to patient health and safety and AMBIENŽ (zolpidem tartrate) CIV -- when taken as directed -- provides a safe and effective treatment to millions of men and women coping with insomnia.
Recent anecdotal reports in the media have focused on rare occurrences of sleepwalking and sleep-related eating in patients who may also be taking AMBIEN. The safety profile of AMBIEN is well established and reported in the AMBIEN Prescribing Information approved by the US Food and Drug Administration (FDA). After recently conducting a thorough analysis sanofi-aventis has not observed any significant change in that safety profile of AMBIEN. The information currently contained in the US Prescribing Information remains accurate: somnambulism is a possible rare adverse event.
One source estimates the incidence of sleepwalking in the general adult population is approximately 4%. Further, patients who experience sleep disorders have been shown to have an increased propensity of sleepwalking and sleep-related eating disorders. Thus, while events of sleepwalking have occurred during treatment with AMBIEN, these instances cannot be systematically linked to the product.
Since the introduction of AMBIEN in the US in 1993, and throughout the 14 billion nights of therapy worldwide provided by zolpidem, the active ingredient of AMBIEN, patient safety has been and will continue to be of paramount importance to sanofi-aventis. As with all of our products, sanofi-aventis continues to closely monitor the safety profile of AMBIEN and we regularly communicate with Health Authorities as part of regular post-marketing safety evaluation of our products.
It is important that AMBIEN only be taken under a doctor's supervision, as outlined in the US Prescribing Information:
* AMBIEN should be taken at the exact dose prescribed by the doctor and should not be taken for extended periods of time or with any other medicines without first talking to the healthcare provider.
* AMBIEN should only be ingested immediately prior to going to bed * AMBIEN should not be taken unless the patient is able to get a full night's sleep before he or she must be active again.
* AMBIEN should not be taken with alcohol.
Patients with questions about AMBIEN, are encouraged to speak with their healthcare providers. Additional product information can be found at the http://www.ambien.com web site.
About AMBIENŽ (zolpidem tartrate) CIV
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 and see accompanying prescribing information.
sanofi-aventis 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. sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY ).
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