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news.The FDA has approved Sanofi-aventis' Ambien CR, an improved formulation of the company's popular insomnia medication, Ambien. Ambien CR is formulated to offer a similar safety profile to Ambien with a new indication for sleep maintenance, in addition to sleep induction.
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According to the company, 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.
With Sanofi-aventis’ patent on Ambien due to expire next year, the company will hope that many customers convert to the new formulation of the drug rather than turning to generic versions of the old formulation that may be released.
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.