Warning Added to Insomnia Drugs for Patients with Hepatic Impairment

A section now includes specific dosing instructions for patients with mild to moderate hepatic impairment
A section now includes specific dosing instructions for patients with mild to moderate hepatic impairment

The Food and Drug Administration (FDA) has approved labeling changes for Ambien (zolpidem tartrate; Sanofi Aventis) and Ambien CR (zolpidem tartrate extended-release; Sanofi Aventis) with updates made to the Dosage and Administration and Warnings and Precautions sections.

Under Dosage and Administration, the Special Populations section now includes specific dosing instructions for patients with mild to moderate hepatic impairment. As these patients do not clear the drug as fast as normal patients, the recommended dose is Ambien 5mg once daily or Ambien CR 6.25mg once daily immediately before bedtime. Both Ambien and Ambien CR should be avoided in patients with severe hepatic impairment as it may contribute to encephalopathy. 

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Under Warnings and Precautions, a new section on Precipitation of Hepatic Encephalopathy has been added. The labeling explains that gamma-aminobutyric acid (GABA) agonists such as zolpidem have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. 

Ambien CR is indicated for the treatment of insomnia characterized by difficulties with sleep initiation while Ambien is approved for short-term insomnia treatment. The main ingredient, zolpidem, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. 

Ambien is available as 5mg strength tablets in 100-count bottles and 10mg strength tablets in 100- and 500-count bottles. Ambien CR is available as 6.25mg strength tablets in 100-count bottles and as 12.5mg strength tablets in 100- and 500-count bottles.

For more information call (800) 633-1610 or visit Ambien.com.