Pregnancy Category B

Uses. Zolpidem became available for medical purposes in the United States during the 1990s, after already being used in Europe. The substance can be used to relax people shortly before they undergo surgery. Zolpidem promotes sleep and has both sedative and anticonvulsant properties. Generally insomnia patients are not supposed to take the drug for much more than a week. They are also not supposed to take the drug until they are ready for sleep; the substance is fast acting, and a person could doze off while in the middle of doing something. Elderly nursing home residents have been known to fall after taking zolpidem. People may forget things they do while under the drug's influence; a U.S. Army test found that the amnesia can be prevented if the drug flumazenil is taken soon enough after a zolpidem dose (flumazenil is used to counteract benzodiazepine depressants).

Scientific studies of zolpidem generally find no hangover drug effects, but people should be careful about what they do after waking up from a dose until they know they are functioning normally. No problem in that regard surfaced when the drug was tested on French military pilots and ground crews to determine if zolpidem could improve rest during prolonged military activity, nor did Swiss researchers find any reduction in performance if athletes used zolpidem to get a good night's sleep before a sporting competition. Not everyone, of course, has the same vigor as those populations. Experimenters running the French military test concluded that the drug is suitable for active military duty, and the substance also has U.S. Air Force approval for aircrew use.

The drug has been used to counteract jet lag, allowing travelers to compensate for changes in their sleep/wake cycles and to function effectively while crossing many time zones. During a simulation of such conditions for long distance troop transport the U.S. Army found that zolpidem worked for promoting sleep but had no advantage over triazolam. Another U.S. Army experiment tested human performance during at least 38 hours of continual wakefulness, with ambiguous results about whether short naps induced by zolpidem would be useful in combat circumstances. French researchers found the drug to be useful for improving quality of sleep in low air pressures found at high altitude (4,000 meters or 13,123 feet) while producing no breathing difficulty, a finding relevant not only to mountaineers but to aviators and astronauts.

Many insomnia medicines produce a rebound effect, meaning that the insomnia comes back worse than ever for a few days after people stop taking the medication. Rebound is seldom observed with zolpidem, however. An experiment with the drug produced temporary improvement in Parkinson's disease symptoms, and zolpidem has helped clear up catatonia. A case report tells of the drug being given to treat anorexia nervosa, a condition in which thin people do not eat much because they imagine they are overweight, but results were unsatisfactory.

Animal experiments show that various chemicals related to zolpidem relieve pain, reduce inflammation and body temperature, and protect against gastric ulcers. Chemically these substances differ from barbiturates and ben-zodiazepines, but have effects similar to them and operate in some ways similar to benzodiazepines. Monkeys responded in ways indicating that zolpidem shares similarities with benzodiazepines but few or none with barbiturates. Despite those resemblances to benzodiazepines, rats trained to distinguish differences in drug effects acted as if zolpidem was unlike the benzodiazepine chlordiazepoxide. Various other differences have been documented. To take one example, caffeine typically counteracts some benzodiazepine actions, but counteraction does not necessarily happen when caffeine is administered with zolpidem. In animal experimentation chemicals related to zolpidem can produce sedation at doses low enough to avoid unwanted effects that occur with benzodiazepine sedation. Substances like zolpidem are generally believed to accomplish some of the same therapeutic actions as benzodiazepines, with less abuse potential.

Drawbacks. Caution is recommended if a depressed person takes zolpidem, as the drug can deepen despondency and even promote suicidal thinking. Less serious occasional unwanted effects include dry mouth, headache, hiccups, nausea, and diarrhea. Hallucinations and other psychotic reactions (ranging from delirium to euphoria) are even less common but documented nonetheless.

Abuse factors. Drug abusers report mental pleasure from zolpidem and say that higher doses feel similar to diazepam. Human experience indicates that tolerance does not occur with zolpidem, although two or three disputed case reports exist. Typically, animals who have been dosed with zolpidem for months show no tolerance, dependence, or withdrawal symptoms. Diligent experimenters, however, have been able to produce dependence and withdrawal in baboons. Those effects have seldom been observed in humans, but case reports exist. Someone took 30 to 40 times the normal daily medical dosage on his own accord for months and developed dependence. This per son showed enough cross-tolerance with clorazepate dipotassium that this chemical could help control withdrawal symptoms caused by Zolpidem dependence, indicating that Zolpidem shares some characteristics with benzodiazepine class depressants. Other reports tell of Zolpidem dependence developing in individuals who had a history of drug abuse. Two clinical studies giving the drug to persons for four weeks also produced dependence. Normally dependence is light enough to cause only mild discomfort upon stopping the drug, but withdrawal seiZures are known among persons who have taken huge doses of Zolpidem for months. However, Zolpidem's abuse liability is low enough that the substance is believed to have special potential for treating ailments in persons prone to drug abuse.

Drug interactions. The antifungus drug ketoconaZole lengthens and increases Zolpidem effects. The tuberculosis drug rifampin shortens and decreases Zolpidem effects.

Cancer. Standard laboratory tests have not indicated that Zolpidem causes cancer. In studies using many times the recommended human dose, no evidence emerged of the drug causing cancer in mice. Rats receiving such high doses developed tumors with no more frequency than rats receiving no dose at all.

Pregnancy. Offspring from pregnant rats and rabbits receiving several times the maximum human therapeutic dosage showed no obvious birth defects, although there were indications of delayed fetal bone development. Standard advice for women is to be cautious about using Zolpidem during pregnancy. Although tests have shown only minute quantities of Zolpidem to pass into a mother's milk (less than 0.02% of a dose taken by a mother), the effect on infants is unknown.

Additional scientific information may be found in:

Boyle, J.A. "Look Again at Information on Zolpidem Tartrate." American Journal of

Hospital Pharmacy 51 (1994): 1354, 1356-57. Fleming, J., et al. "Comparison of the Residual Effects and Efficacy of Short Term Zolpidem, FluraZepam and Placebo in Patients with Chronic Insomnia." Clinical Drug Investigation 9 (1995): 303-13. Hoehns, J.D., and P.J. Perry. "Zolpidem: NonbenZodiaZepine Hypnotic for Treatment of Insomnia." Clinical Pharmacy 12 (1993): 814-28. Lobo, B.L., and W.L. Greene. "Zolpidem: Distinct from TriaZolam?" Annals of Pharmacotherapy 31 (1997): 625-32. Rush, C.R. "Behavioral Pharmacology of Zolpidem Relative to BenZodiaZepines: A Review." Pharmacology, Biochemistry, and Behavior 61 (1998): 253-69. Toner, L.C., et al. "Central Nervous System Side Effects Associated with Zolpidem

Treatment." Clinical Neuropharmacology 23 (2000): 54-58. "Zolpidem for Insomnia." Medical Letter on Drugs and Therapeutics 35 (1993): 35-36.

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