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BY OUR PHARMA CORRESPONDENT
8 September,2005: Extended-release tablets
of zolpidem tartrate has been granted approval to
treat insomnia by the US Food and Drug
Administration (FDA). The sleep-aid drug is now
available in name of Ambien.
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,
said an official release from sanofi-aventis,the
maker of the drug .
The 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.Ambien CR has shown evidence of
promoting sleep onset and more continuous sleep,
noted the release.
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.
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, the company release
said.
Sanofi-aventis is the leading pharmaceutical
company in Europe. sanofi-aventis is developing
therapies in seven major areas: cardiovascular,
thrombosis, oncology, metabolic disorders, central
nervous system, internal medicine, and vaccines.
Sanofi-aventis Group subsidiaries in the United
States include Sanofi-Synthelabo Inc., and Aventis
Pharmacuticals Inc. and Sanofi Pasteur Inc.
BY OUR PHARMA CORRESPONDENT |
