FDA Approves Sanofi Aventis's Ambien CR

Treating insomnia (trouble falling asleep or staying asleep). Ambien CR Extended-Release Tablets are a sedative-hypnotic, or sleep medicine.

It works by helping to increase certain natural chemicals in the brain that cause sleep. Ambien CR is a dual-layer tablet - the first layer is designed to dissolve quickly to help you get to sleep and the second layer is designed to dissolve slowly, to help you stay asleep.

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved AMBIEN CR™ (zolpidem tartrate extended-release tablets) CIV, a new extended-release formulation of the number one prescription sleep aid, AMBIEN® (zolpidem tartrate) CIV, for the treatment of insomnia. 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.

AMBIEN CR 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.

Ambien CR (zolpidem tartrate extended-release tablets), a new extended-release formulation of the prescription sleep aid, Ambien (zolpidem tartrate), has been FDA approved for the treatment of insomnia. Many arthritis patients are prescribed a sleep medication as part of their treatment plan. The pain associated with arthritis often interferes with sleep.

Ambien CR is non-narcotic and a non-benzodiazepine, formulated to offer a new indication for sleep maintenance, in addition to sleep induction. Ambien CR, a bi-layered tablet. 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 will be available in a 12.5 mg dose recommended for adults and a 6.25 mg dose recommended for the elderly.

Ambien is indicated for only short-term treatment of insomnia. Ambien has been
shown to decrease sleep latency and increase the duration of sleep for up to 35
days. Ambien can be prescribed in quantiities exceeding a one-month supply.

Ambien CR is non-narcotic and non-benzodiapzepine for the treatment of insomnia
with a similar safety profile to Ambien and a new indication for sleep maintensance,
in addition to sleep induction. According to the news, Ambien CR is the first and
only extended-release prescription to help people with insomnia fall asleep fast
without a significant decrease in next day performance.

Ambien CR has two layers. One layer dissolves quickly to induce the effect while
another one dissolves slowly to provide a continuous sleep.