Sanofi-aventis
(Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) today announced
results from a study that demonstrated AMBIEN CR is well-tolerated and
effective in improving sleep onset and maintenance for up to six months in
patients with chronic primary insomnia when taken as needed for up to seven
nights per week, without rebound insomnia following discontinuation. These
data are being presented on July 12 in Chicago at the CINP (Collegium
Internationale Neuro- Psychopharmacologicum) 25th Biennial Congress, a
meeting ground for clinicians and scientists to report new scientific
evidence in biochemistry, pharmacology, safety, and therapeutic efficacy of
neuropsychiatric drugs.
According to the data, AMBIEN CR demonstrated significant improvements
in total sleep time (TST), sleep onset latency (SOL), wake time after sleep
onset (WASO), sleep quality, and number of awakenings versus placebo.
AMBIEN CR is the first and only controlled release prescription sleep
medicine approved by the FDA for sleep induction and sleep maintenance.
"These data are important for patients who experience chronic insomnia
because they demonstrate there is a treatment option in AMBIEN CR that can
be taken safely and effectively as needed long-term to help them both fall
asleep and maintain sleep through the night," said Tom Roth, PhD, director,
Sleep Disorders Center, Henry Ford Hospital.
About the Study
This multicenter, double-blind, placebo-controlled evaluation of AMBIEN
CR 12.5mg involved 1,018 adult volunteers who were studied for a period of
25 weeks. The objective of this study was to evaluate the long-term safety
and efficacy of AMBIEN CR taken as needed up to 7 nights per week. Efficacy
was assessed by Patient Global Impression (PGI) and Clinical Global
Impression (CGI) scales every 4th week and daily morning questionnaires.
The PGI scale requires patients to rate how much their condition has
improved or worsened relative to baseline. The Clinical Global Impression
(CGI) scale requires the clinician to rate how much the patient's condition
has improved or worsened relative to baseline. The primary endpoint of the
study was the 12-week PGI aid to sleep. Rebound insomnia was evaluated the
first three nights after treatment discontinuation at the end of the study.
Study Results
In PGI measurements for the AMBIEN CR group at weeks 12 and 24, 89.8%
and 92.3% of patients reported that treatment helped them sleep versus
51.4% and 59.7% of patients in the placebo group. From score analysis,
AMBIEN CR significantly improved PGI versus placebo at each 4-week interval
of the 24- week treatment period (P
About Insomnia
Chronic insomnia affects approximately 30 million Americans, according
to a 2006 report of the Institute of Medicine Committee (IOM) on Sleep
Medicine and Sleep Research. The long-term effects of sleep disorders have
been associated with a variety of serious medical conditions.
Insomnia can lead to stress and reduced productivity, and thus may be
costly to the workplace. Research shows insomnia can be a predictor of
absenteeism. Poor work efficiency has been demonstrated in insomniacs
compared to normal sleepers. Chronic and occasional insomniacs were both
more likely to doze off during daytime activities or when bored, and to
take naps than individuals who do not experience insomnia.
About AMBIEN CR
AMBIEN CR is the first and only controlled-release formula prescription
sleep medication approved by the FDA for sleep maintenance in addition to
sleep induction. AMBIEN CR is a bi-layered tablet 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.
AMBIEN CR is indicated for treating insomnia. It is a treatment option
you and your healthcare professional can consider along with lifestyle
changes and can be taken for as long as your healthcare professional
recommends. Until you know how AMBIEN CR will affect you, you shouldn't
drive or operate machinery. Be sure you're able to devote 7 to 8 hours to
sleep before being active again. Side effects may include next-day
drowsiness, dizziness and headache. It's non-narcotic; however, like most
sleep medicines it has some risk of dependency. Don't take it with alcohol.
For full prescribing information, please visit AMBIENCR and see accompanying prescribing information.
About sanofi-aventis
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)
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying
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management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties,
many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward- Looking Statements"
in sanofi-aventis' annual report on Form 20-F for the year ended December
31, 2005. Other than as required by applicable law, sanofi- aventis does
not undertake any obligation to update or revise any forward- looking
information or statements.
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