Sanofi-Aventis received FDA approval for zolpidem tartrate extended-release tablets (Ambien CR) for the treatment of insomnia. The new formulation is a nonnarcotic, nonbenzodiazepine formulated to offer a similar profile to Ambien, with a new indication for sleep maintenance in addition to sleep induction.

Zolpidem tartrate extended-release is a bilayered tablet, delivered in two stages. The first layer dissolves quickly to induce sleep; the second layer is released gradually to provide more continuous sleep.

Food and Drug Administration approval was based on results from clinical trials showing that use of the drug decreased wake time after sleep onset for the first 7 hours during the first 2 nights and for the first 5 hours after 2 weeks of treatment. Compared with placebo, use of zolpidem tartrate extended-release decreased latency to persistent sleep during the first 2 nights of treatment and after 2 weeks of treatment.

Zolpidem tartrate extended-release will be available in a 12.5 mg dose recommended for adults and a 6.25 mg dose recommended for the elderly.

Side effects associated with zolpidem tartrate extended-release include drowsiness, dizziness, and diarrhea. The medication should not be taken with alcohol. Patients planning to take Ambien should be able to devote 7 to 8 hours of sleep before becoming active again.