STILNOX ZOLPIDEM (originally marketed as Ambien and available worldwide under many brand names) is a sedative primarily used for the treatment of insomnia. It works quickly, usually within 15 minutes, and has a short half-life of two to three hours.STILNOX ZOLPIDEM has not adequately demonstrated effectiveness in maintaining sleep, unless delivered in a controlled-release (CR) form. However, it is effective in initiating sleep. Its hypnotic effects are similar to those of the benzodiazepine class of drugs.
In 2013, the Food and Drug Administration required manufacturers to decrease the recommended dose for women by half, after studies showed that the medicines can leave people drowsy in the morning and at risk for motor vehicle collisions. The FDA recommended that manufacturers extend the new dosage cuts to men as well, who process the drug at a faster rate; however, the reasons men and women metabolize the drugs at different rates are still unknown. In May 2013, the FDA approved label changes specifying new dosage recommendations for STILNOX ZOLPIDEM products because of concerns regarding next-morning impairment. The underlying mechanism involves GABA.
It is a short-acting nonbenzodiazepine compound of the imidazopyridine class that increases the activity of GABA, an inhibitory neurotransmitter, by binding to GABAA receptors at the same location as benzodiazepines. It is molecularly distinct from the classical benzodiazepine molecule and is classified as an imidazopyridine. Flumazenil, a benzodiazepine receptor antagonist, which is used for benzodiazepine overdose, can also reverse zolpidem’s sedative/hypnotic and memory-impairing effects.
The United States patent for STILNOX ZOLPIDEM was held by the French pharmaceutical corporation Sanofi-Aventis. On April 23, 2007, the U.S. Food and Drug Administration (FDA) approved 13 generic versions of zolpidem tartrate. STILNOX ZOLPIDEM is available from several generic manufacturers in the UK, as a generic from Sandoz in South Africa and TEVA in Israel, as well as from other manufacturers such as Ratiopharm and Takeda GmbH (both Germany).