Ambien CR

SANOFI-AVENTIS

Extended-release hypnotic approved for improving sleep onset and maintenance

This non-benzodiazepine hypnotic is delivered in 2 stages through the use of a bi-layered tablet. The first layer dissolves quickly to induce sleep, while the second layer is released more gradually to improve sleep maintenance. Extended-release zolpidem was approved on September 2, 2005, for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Safety. Like other sedative/hypnotic drugs, extended-release zolpidem has CNS-depressant effects. Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of extended-release zolpidem. An additive effect on psychomotor performance between alcohol and zolpidem has been demonstrated. Due to its rapid onset of action, extended-release zolpidem should only be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous activities requiring complete mental alertness or motor coordination after ingesting the drug. Sedative/hypnotic drugs should be administered with caution to patients exhibiting signs or symptoms of depression. Zolpidem is classified as a Schedule IV controlled substance under the Controlled Substances Act. Patients with a history of addiction to, or abuse of, drugs or alcohol should be monitored carefully when receiving extended-release zolpidem since these individuals are at an increased risk for misuse and abuse of the drug and addiction to the drug. The most commonly reported adverse events associated with extended-release zolpidem are headache, somnolence, and dizziness.

Dosing. The recommended dose of extended-release zolpidem for non-elderly adults is 12.5 mg immediately before bedtime. The recommended dose of extended-release zolpidem for elderly (aged ≥65 y) or debilitated patients or patients with hepatic insufficiency is 6.25 mg immediately before bedtime. Zolpidem extended-release tablets should be swallowed whole, not divided, chewed, or crushed.