Sanofi-aventis
announced results from a new study that showed Ambien CR(R) (zolpidem
tartrate extended-release) CIV tablets 12.5 mg provided significant
improvement in sleep onset, sleep maintenance and total sleep time over 8
weeks in patients with co-morbid insomnia and major depressive disorder
(MDD) who were administered a Selective Serotonin Reuptake Inhibitor (SSRI)
for depression. Ambien CR also improved sleep-related next-day functioning
measures. This data was presented at the SLEEP 2008 22nd Annual Meeting of
the Associated Professional Sleep Societies (APSS).
Thomas Roth, PhD, director of the Sleep Disorders and Research Center
at Henry Ford Hospital, states, "The results of this study demonstrate that
Ambien CR can be considered a viable treatment option for the insomnia MDD
patients experience and help them get the good night's sleep they need to
improve their next-day functioning."
Ambien CR Improved Sleep Quality and Sleep Impact on Daily Activities
in MDD Patients
Total sleep time was increased in the Ambien CR group throughout the
study. At Week eight, patients reporting sleeping an average of 101 minutes
more than baseline compared to placebo-treated patients who reported
sleeping an average 64 minutes more (P
Similar improvements in sleep onset, maintenance and total sleep time
and related next-day function were also demonstrated in an earlier study of
Ambien CR in patients with insomnia and co-morbid general anxiety disorder
(GAD). It was the third largest, recently-completed clinical study of
Ambien CR that demonstrated improved measurements of next-day function as
related to improving sleep induction and sleep maintenance symptoms of
insomnia.
About the Study
This was a multi-center, double-blind, parallel-group, randomized,
placebo controlled study in 383 adults ages 21 to 64 with co-morbid
insomnia and MDD. The study evaluated the overall improvement of insomnia,
as measured by total sleep time and in patients treated with Ambien CR and
the antidepressant escitalopram (Lexapro(R)) 10 mg compared to treatment
with placebo and escitalopram. Patients received Ambien CR 12.5 mg (n=193)
or placebo (n=192) each night and 10 mg of escitalopram each day during the
24-week study.
Researchers assessed treatment efficacy through daily patient-reported
Morning Sleep Questionnaires (MSQ) and during bi-weekly visits for eight
weeks and every fourth week if the patients (depression responders) were
part of an additional 16-week treatment period. The MSQ measured the
primary efficacy outcome of total sleep time in addition to secondary
measurements of sleep onset latency, wake time after sleep onset, number of
awakenings, quality of sleep and sleep-related next-day functioning.
About Insomnia
Insomnia -- difficulty falling asleep, staying asleep or waking too
early and not being able to get back to sleep - is one of the most common
sleep problems. Approximately 50 to 70 million Americans are affected by
insomnia each year, which can lead to a range of overall health and medical
implications.
About Ambien CR(R) (zolpidem tartrate extended-release) CIV tablets
Ambien CR is indicated for the treatment of insomnia, characterized by
difficulties with sleep onset and/or sleep maintenance (as measured by wake
time after sleep onset). Ambien CR is not indicated for the treatment of
MDD or GAD.
Important Safety Information
Ambien CR is indicated for the treatment of insomnia. Ambien CR is not
indicated for the treatment of MDD or GAD. Due to its rapid onset of
action, patients should take Ambien CR right before going to bed and when
ready for sleep. Patients should not take Ambien CR unless they are
prepared to get a full night's sleep (7 to 8 hours) to avoid residual
effects. Until they know how it will affect their physical or mental
performance upon awakening, patients should not drive or operate hazardous
machinery after taking Ambien Cr or any other sleep medication. Complex
behaviors such as somnambulism, including driving or eating while not fully
awake, with amnesia for the event, have been reported in patients who have
taken a sedative hypnotic. Discontinuation of Ambien CR should be strongly
considered for patients reporting such complex behaviors. Rare cases of
angioedema have been reported in patients after taking sedative hypnotics.
Patients who develop andioedema should not be rechallenged.
Sedative/hypnotic drugs should be administered with caution to patients
exhibiting signs or symptoms of depression. Suicidal tendencies may be
present in such patients and protective measures may be required.
Intentional overdosage is more common in this group of patients; therefore,
the least amount of drug that is feasible should be prescribed for the
patient at any one time. The most commonly observed adverse effects in
controlled clinical trials were headache, somnolence and dizziness.
For full prescribing information, please visit AmbienCR
About Sanofi Aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. 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, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include financial projections and estimates and their
underlying assumptions, statements regarding plans, objectives, intentions
and expectations with respect to future events, operations, products and
services, and statements regarding future performance. Forward-looking
statements are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar expressions.
Although sanofi-aventis' 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, 2007. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or revise
any forward-looking information or statements.
Sanofi Aventis
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