BRIDGEWATER, N.J., Jan. 4 /PRNewswire-FirstCall/ -- Sanofi-aventis
announced today results from a new study that showed Ambien CR(R) (zolpidem
tartrate extended-release) tablets CIV provided improvement in sleep onset,
sleep maintenance and total sleep time for patients with co-morbid chronic
insomnia and generalized anxiety disorder (GAD) compared to placebo. Ambien
CR also improved sleep-related next-day functioning measures.
About the Study
This study was a multi-center, double-blind, parallel-group,
randomized, placebo-controlled trial in 381 adults ages 21 to 64 with
co-morbid chronic insomnia and GAD. The study evaluated the overall
improvement of insomnia, as measured by total sleep time in patients
treated with Ambien CR and the antidepressant escitalopram (Lexapro(R))
compared to treatment with placebo and escitalopram. Patients received
Ambien CR 12.5 mg (n=191) or placebo (n=190) each night followed by 10 mg
of escitalopram each day during the 8-week study, followed by a one-week
period of escitalopram only. Treatment was well tolerated during the study
and adverse events were similar between treatment groups.
"The anxiety experienced by patients with GAD can often lead to sleep
problems such as difficulty falling asleep or staying asleep," says Thomas
Roth, PhD, director of the Sleep Disorders and Research Center at Henry
Ford Hospital. "Data from this study show that Ambien CR can be considered
a treatment option for the insomnia in GAD to help them get the full
night's sleep they need to maintain their next-day functioning."
Researchers assessed treatment efficacy during clinic visits at Weeks
1, 2, 4, 6 and 8 and through daily patient-reported Morning Sleep
Questionnaires (MSQ). The MSQ measured the primary efficacy outcome of
total sleep time in addition to measurements of sleep onset latency, wake
time after sleep onset, number of awakenings, quality of sleep and
sleep-related next-day functioning.
Ambien CR Improved Sleep Quality and Sleep Impact on Daily Activities
in GAD Patients
Total sleep time was increased in the Ambien CR group throughout the
study. At Week 8, patients reporting sleeping an average of 106 minutes
more than baseline compared to placebo-treated patients who reported
sleeping an average 68 minutes more (P<0.0001). On average, Ambien
CR-treated patients reported falling asleep sooner and exhibited improved
sleep maintenance based upon fewer nighttime awakenings and decreased wake
time after sleep onset compared to placebo-treated patients (P<0.0001). At
Week 8, the number of nighttime awakenings decreased in the Ambien
CR/escitalopram group (-1.33 + or - 1.26) compared to the
placebo/escitalopram group (-0.76 + or - 1.02), and time to sleep onset was
reduced 55.1 (+ or - 67.3) minutes with Ambien CR compared to a reduction
of 26.8 (+ or - 58.7) minutes with placebo (P<0.0001). In addition,
patients reported improvements in secondary measures relating to daytime
functioning, including morning energy, morning concentration and sleep
impact on daily activities.
Adverse events occurred in 76% of patients treated with Ambien
CR/escitalopram and 71% of the patients treated with placebo/escitalopram.
The most frequent adverse events experienced by both treatment groups were
nausea, dizziness and fatigue. These adverse events have been reported in
previous studies of both Ambien CR and escitalopram and are known to be
part of the safety profile of both treatments. One patient in each
treatment group experienced different serious adverse events.
About Insomnia
Insomnia can be a serious medical condition characterized by difficulty
falling asleep, difficulty staying asleep (waking up often during the night
and having trouble going back to sleep), waking up too early in the morning
and feeling tired upon waking. About 10% of Americans are affected by
chronic insomnia each year.
Patients with chronic insomnia report higher rates of absenteeism and
demonstrate poor work efficiency compared to normal sleepers. Insomnia can
lead to stress and reduced productivity, and thus may be costly to the
workplace.
About Ambien CR(R) (zolpidem tartrate extended-release tablets) CIV
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).
Important Safety Information
Ambien CR is a treatment option you and your healthcare provider can
consider along with lifestyle changes and can be taken for as long as your
provider 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. Sleepwalking, and eating or
driving while not fully awake, with amnesia for the event, have been
reported. If you experience any of these behaviors contact your provider
immediately. In rare cases, sleep medicines may cause allergic reactions
such as swelling of your tongue or throat, shortness of breath or more
severe results. If you have an allergic reaction while using Ambien CR,
contact your doctor immediately. 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 http://www.AmbienCR.com.
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).
Contact: Terri Pedone, sanofi-aventis, (908) 981-6562;
terri.pedone@sanofi-aventis.com
SOURCE sanofi-aventis
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Related links:
http://www.sanofi-aventis.us
http://www.sanofi-aventis.com http://www.AmbienCR.com
http://www.prnewswire.com/comp/232375.html /
CONTACT:
Terri Pedone of sanofi-aventis,
+1-908-981-6562, terri.pedone@sanofi-aventis.com
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