Sanofi-Aventis Revises Stilnox Warning Label in Australia

The Australian Therapeutic Goods Administration (TGA) has asked sanofi-aventis to add an alcohol use contraindication to the labeling of its insomnia drug Stilnox in response to recent reports of unusual sleep behaviors, the company announced. The label already contains a precaution describing potential adverse events when used with alcohol.

While the potential for sleepwalking, hallucinations and amnesia is reflected in the Stilnox (zolpidem tartrate) labeling, sanofi-aventis said that a causal relationship between these events and the drug has not been established.

"Furthermore it is important to note that complex sleep-related behaviors have also been reported with other medications," the company said.

In addition to the label change, the company has proposed to the TGA educational initiatives aimed at reinforcing the appropriate use of Stilnox.

Last month the U.S. FDA issued a recommendation to manufactures of sleeping drugs -- including sanofi-aventis, which markets zolpidem as Ambien in the U.S. -- to conduct clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports.