FDAnews
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FDA APPROVES AMBIEN CR CIV

September 6, 2005

Sanofi-aventis has announced that the FDA has approved Ambien CR CIV, a new extended-release formulation of the prescription sleep aid, Ambien 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 helps people with insomnia fall asleep fast and maintain sleep with no significant decrease in next-day performance. Ambien CR, a bilayered tablet, is delivered in two stages -- the first layer dissolves quickly to induce sleep, while the second layer is released more gradually into the body to help provide more continuous sleep.