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AMBIEN (zolpidem) can be very effective in the short-term treatment of insomnia. While natural sleep is best, AMBIEN (zolpidem) can help you fall asleep, stay asleep, and not awaken prematurely. AMBIEN (zolpidem) works with a natural brain chemical called GABA. GABA is one of at least 18 major brain chemicals known as neurotransmitters. Neurotransmitters control communication among neighboring brain cells by either increasing or decreasing their electrical activity. Once released from a brain cell, it is hypothesized that GABA dampens the electrical activity of neighboring brain cells and that AMBIEN (zolpidem)works with GABA to further reduce the possibility of certain brain cells becoming electrically active. AMBIEN (zolpidem) is not chemically related to many older sleep drugs that work with GABA. Laboratory studies have shown that unlike these older sleep drugs, AMBIEN (zolpidem) targets a specific area of the brain cell. This specific targeting may result in fewer side effects. 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NOTES: Elderly persons are usually more sensitive to the effects of this medication. Use cautiously. You may experience sleeping difficulties on the first night after stopping this medication. Be aware of this effect. If the problem continues, contact your doctor. MISSED DOSE: Take your dose at or near bedtime. If you miss a dose, do not take it if it is near the time for your next dose. Instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. STORAGE: Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom. 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This medication is usually taken for short periods of 7 to 10 days. Take this exactly as prescribed. Do not increase the dose or take this for longer than prescribed. SIDE EFFECTS: Daytime drowsiness, dizziness, headache, nausea, stomach upset, vomiting, diarrhea, lightheadedness, and dry mouth may occur. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop any of these serious side effects while taking this medication: chest pain, rapid heart rate, difficulty breathing, skin rash, fever, behavior changes, mental confusion, abnormal thinking, depression. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Also avoid intake of alcoholic beverages which will aggravate these effects. Because this medication causes drowsiness, use caution engaging in activities requiring alertness. If you notice other effects not listed above, contact your doctor or pharmacist. 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Visit us today! www.choicerxpharmacy.com Is Ambien® (Zolpidem) the right sleep aid for you? by Cassandra Walters ConsumerHealthDigest.com We have discussed several topics in the ConsumerHealthDigest.com sleep forum including: sleep apnea, narcolepsy, sleep paralysis and delayed sleep phase syndrome. The one “sleep” topic that receives the most inquiries is insomnia. This interest is an indication to us that many people are having difficulty falling and staying asleep. How frustrating it must be to be unable to experience a full, restful night’s sleep. Insomnia is defined as prolonged and usually abnormal inability to obtain adequate sleep. It is actually a symptom of an underlying condition, rather than an actual disease. Many times underlying conditions influence a person’s ability to achieve and maintain restful slumber. Painful conditions such as arthritis and neuralgia can interfere with sleep. Any injury that makes it uncomfortable to lie down, especially those injuries to the back or neck, can make sleeping difficult. Additionally, other sleep disorders, such as sleep apnea, sleep paralysis and night terrors or nightmares can contribute to insomnia. The effects of insomnia can be devastating to the insomniac. Obviously, insomnia is directly related to sleep deprivation. Sleep deprivation can impact an individual’s memory, as well as their ability to concentrate. Irritability and depression are also common effects of insomnia and the associated sleep deprivation. In addition, recent research has revealed that a link has been established between insomnia and many gastrointestinal illnesses, particularly irritable bowel syndrome. What help is available to those suffering from insomnia? Relief from the inability to achieve and maintain sleep is available. The use of sleep aids to restore natural sleep patterns has been successful at helping those suffering from insomnia to end their sleep deprivation and get their lives back on track. Prescription medications and all natural sleep aids are currently available to treat insomnia. Prescription Drug Ambien® Ambien® (generic name zolpidem) is a sedative available only by doctor’s prescription. It must be taken regularly for a few days before any benefit is noticed. Use of Ambien® should never be discontinued without first consulting your physician. Individuals who use Ambien® should avoid alcohol when taking this drug, as the combination may cause coma and even death. Although Ambien® is not a narcotic, it could become habit forming. Using strong drugs to fall asleep often means that the body's natural sleep cycle is disturbed and the ability to fall asleep naturally is lost, contrary to what you are trying to achieve. This should be kept in mind when considering any prescription sedative to treat insomnia. Medication Quantity Average Price** Ambien 5 mg 30 tabs $127.00 Ambien 5 mg 60 tabs $207.00 Ambien 5 mg 90 tabs $299.00 Ambien 10 mg 30 tabs $146.00 Ambien 10 mg 60 tabs $226.00 Ambien 10 mg 90 tabs $359.00 Non Prescription All Natural Sleep Products There are many elite non-prescription products currently marketed as sleep aids. These products are so appealing due to their all natural formulations, the fact that they are not physically addictive and their low incidence of side effects and drug interactions. One of the main ingredients in these all natural products is Valerian Root. Valerian Root works to induce and maintain sleep through a two step mechanism: Stage 1: your body experiences a state of powerful relaxation. Stage 2: your body experiences an improved quality of sleep by inducing longer periods of restfulness. To achieve a full and restful night’s sleep you may not need to resort to prescription strength drugs. All natural supplements can support a sound and restful night's sleep. They provide an excellent alternative to prescription strength sleeping drugs. These products have limited side effects, less drug interactions, and in addition, are less expensive than most prescription sedatives currently available. Also, unlike prescription sleep aids, all natural sleep aids can be used only on the nights when you really need it. They can be taken prior to going to bed, or even in the middle of the night, if you go to bed and discover you are unable to sleep. What all natural sleep aids come out on top? We reviewed over 50 different all natural sleep aids on the market today. Our choices for the top three all natural sleep aids currently available are presented in the table below. Ambien This page contains drug information on Ambien. The information provided includes the following: what is Ambien the possible side effects of Ambien what happens if you miss a dose of Ambien what happens if you overdose with Ambien the most important information about Ambien how to use Ambien other drugs that may affect Ambien what to avoid while using Ambien Generic Name: zolpidem (zole PI dem) Brand Names: Ambien, Ambien CR What is the most important information I should know about zolpidem? • Use caution when driving, operating machinery, or performing other hazardous activities. Zolpidem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Zolpidem should be taken just before bedtime. You may experience some carryover effects the next day. • Do not drink alcohol while taking zolpidem. Alcohol will increase drowsiness and may increase dizziness while you are taking zolpidem, which could be dangerous. • Do not stop taking zolpidem suddenly if you have been taking it for more than 1 or 2 weeks. This may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with zolpidem. • Do not crush, chew, or break the controlled-release zolpidem tablets. Swallow the controlled-release tablets whole. What is zolpidem? • Zolpidem is in a class of drugs called sedative/ hypnotics or sleep medications. Zolpidem affects chemicals in your brain that may become unbalanced and cause insomnia. • Zolpidem induces sleep and causes relaxation. It is used to treat sleep disorders such as trouble falling asleep, waking up many times during the night, or waking up too early in the morning. Zolpidem is for short-term use only--usually 7 to 10 days. Longer-term use must be monitored closely by a doctor. • Zolpidem may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking zolpidem? • Before taking this medication, tell your doctor if you · have kidney disease; · have liver disease; · have asthma, bronchitis, emphysema, or another respiratory disease; or · are depressed or have suicidal thoughts. • You may not be able to take zolpidem, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. • Zolpidem is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take zolpidem without first talking to your doctor if you are pregnant or could become pregnant during treatment. • Zolpidem passes into breast milk and may affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. • If you are over 60 years of age, you may be more likely to experience side effects from zolpidem. You may require a lower dose of this medication. • Zolpidem is not approved by the FDA for use by children younger than 18 years of age. How should I take zolpidem? • Take zolpidem exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Take zolpidem just before you go to bed. It will make you drowsy, and you could fall and hurt yourself if you take your dose before you are ready for sleep. • Take zolpidem only if you are able to get a full night's sleep before you must be active again. • Do not take more of this medication than is prescribed for you. • Do not stop taking zolpidem suddenly if you have been taking it for more than 1 or 2 weeks. This may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with zolpidem. • Do not crush, chew, or break the controlled-release zolpidem tablets. Swallow the controlled-release tablets whole. • Store zolpidem at room temperature away from moisture and heat. What happens if I miss a dose? • Since zolpidem is usually taken only if you need it to help you sleep, missing a dose will not cause any problems. Take the missed dose only if you can be sure that you will get 7 or 8 full hours of sleep after the dose. If you do not sleep for 7 or 8 full hours, you may experience carryover effects from zolpidem after you wake up. What happens if I overdose? • Seek emergency medical attention. • Symptoms of a zolpidem overdose may include sleepiness, confusion, dizziness, difficult or slow breathing, and unconsciousness. What should I avoid while taking zolpidem? • Use caution when driving, operating machinery, or performing other hazardous activities. Zolpidem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Zolpidem should be taken just before bedtime. You may experience some carryover effects the next day. • Do not drink alcohol while taking zolpidem. Alcohol will increase drowsiness and may increase dizziness while you are taking zolpidem, which could be dangerous. • Avoid other sedatives, sleeping pills, and tranquilizers, including over-the-counter preparations. They should not be used while you are taking zolpidem unless your doctor directs otherwise. What are the possible side effects of zolpidem? • If you experience any of the following serious side effects, stop taking zolpidem and seek emergency medical attention: · an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, face, or tongue; hives); or · hallucinations, abnormal behavior, or severe confusion. • Other, less serious side effects may be more likely to occur. Continue to take zolpidem and talk to your doctor if you experience · headache, drowsiness, dizziness, or clumsiness; · nausea, vomiting, diarrhea, or constipation; · depression; · muscle aches or pains; · vivid or abnormal dreams; or · amnesia (memory loss) after a dose. • A problem that may occur when sleep medicines are stopped is known as "rebound insomnia." This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. If you should experience rebound insomnia, do not get discouraged. This problem usually goes away on its own after 1 or 2 nights • Zolpidem is habit forming. Stopping this medication suddenly can cause withdrawal effects if you have taken it continuously for several weeks. Talk to your doctor about the safe use of this medication. • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect zolpidem? • Zolpidem may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, other sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves. • Drugs other than those listed here may also interact with zolpidem. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products. Where can I get more information? • Your pharmacist has additional information about zolpidem written for health professionals that you may read. Ambien Tablets Manufacturer: Sanofi-Synthelabo DESCRIPTION Ambien (zolpidem tartrate), is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5-mg and 10-mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide; the 5-mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80. CLINICAL PHARMACOLOGY Pharmacodynamics: Subunit modulation of the GABA A receptor chloride channel macromolecular complex is hypothesized to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties. The major modulatory site of the GABA A receptor complex is located on its alpha ((alpha)) subunit and is referred to as the benzodiazepine (BZ) or omega ((omega)) receptor. At least three subtypes of the ((omega)) receptor have been identified. While zolpidem is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which nonselectively bind to and activate all omega receptor subtypes, zolpidem in vitro binds the ((omega) 1 ) receptor preferentially with a high affinity ratio of the alpha 1 /alpha 5 subunits. The ((omega) 1 ) receptor is found primarily on the Lamina IV of the sensorimotor cortical regions, substantia nigra (parsreticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. This selective binding of zolpidem on the ((omega) 1 ) receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses. Pharmacokinetics: The pharmacokinetic profile of Ambien is characterized by rapid absorption from the GI tract and a short elimination half-life (T 1/2 ) in healthy subjects. In a single-dose crossover study in 45 healthy subjects administered 5- and 10-mg zolpidem tartrate tablets, the mean peak concentrations (C max ) were 59 (range: 29 to 113) and 121 (range: 58 to 272) ng/mL, respectively, occurring at a mean time (T max ) of 1.6 hours for both. The mean Ambien elimination half-life was 2.6 (range: 1.4 to 4.5) and 2.5 (range: 1.4 to 3.8) hours, for the 5- and 10-mg tablets, respectively. Ambien is converted to inactive metabolites that are eliminated primarily by renal excretion. Ambien demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Zolpidem did not accumulate in young adults following nightly dosing with 20-mg zolpidem tartrate tablets for 2 weeks. A food-effect study in 30 healthy male volunteers compared the pharmacokinetics of Ambien 10 mg when administered while fasting or 20 minutes after a meal. Results demonstrated that with food, mean AUC and C max were decreased by 15% and 25%, respectively, while mean T max was prolonged by 60% (from 1.4 to 2.2 hr). The half-life remained unchanged. These results suggest that, for faster sleep onset, Ambien should not be administered with or immediately after a meal. In the elderly, the dose for Ambien should be 5 mg (see Precautions and Dosage and Administration ). This recommendation is based on several studies in which the mean C max , T 1/2 , and AUC were significantly increased when compared to results in young adults. In one study of eight elderly subjects (>70 years), the means for C max , T 1/2 , and AUC significantly increased by 50% (255 vs 384 ng/mL), 32% (2.2 vs 2.9 hr), and 64% (955 vs 1,562 ng hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20-mg oral zolpidem dose. Ambien did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week. The pharmacokinetics of Ambien in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single 20-mg oral zolpidem dose, mean C max and AUC were found to be two times (250 vs 499 ng/mL) and five times (788 vs 4,203 ng hr/mL) higher, respectively, in hepatically compromised patients. T max did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normals of 2.2 hr (range: 1.6 to 2.4 hr). Dosing should be modified accordingly in patients with hepatic insufficiency (see Precautions and Dosage and Administration ). The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage renal failure (mean Cl Cr = 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for C max , T max , half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. On day 1, C max was 172 ± 29 ng/mL (range: 46 to 344 ng/mL). After repeated dosing for 14 or 21 days, C max was 203 ± 32 ng/mL (range: 28 to 316 ng/mL). On day 1, T max was 1.7 ± 0.3 hr (range: 0.5 to 3.0 hr); after repeated dosing T max was 0.8 ± 0.2 hr (range: 0.5 to 2.0 hr). This variation is accounted for by noting that last-day serum sampling began 10 hours after the previous dose, rather than after 24 hours. This resulted in residual drug concentration and a shorter period to reach maximal serum concentration. On day 1, T 1/2 was 2.4 ± 0.4 hr (range: 0.4 to 5.1 hr). After repeated dosing, T 1/2 was 2.5 ± 0.4 hr (range: 0.7 to 4.2 hr). AUC was 796 ± 159 ng hr/mL after the first dose and 818 ± 170 ng· hr/mL after repeated dosing. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Ambien (zolpidem tartrate) pharmacokinetics were not significantly different in renally impaired patients. No dosage adjustment is necessary in patients with compromised renal function. As a general precaution, these patients should be closely monitored. Postulated relationship between elimination rate of hypnotics and their profile of common untoward effects: The type and duration of hypnotic effects and the profile of unwanted effects during administration of hypnotic drugs may be influenced by the biologic half-life of administered drug and any active metabolites formed. When half-lives are long, drug or metabolites may accumulate during periods of nightly administration and be associated with impairment of cognitive and/or motor performance during waking hours; the possibility of interaction with other psychoactive drugs or alcohol will be enhanced. In contrast, if half-lives, including half-lives of active metabolites, are short, drug and metabolites will be cleared before the next dose is ingested, and carryover effects related to excessive sedation or CNS depression should be minimal or absent. Ambien has a short half-life and no active metabolites. During nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug or its active metabolites (ie, in relationship to the receptor site) may occur at some point in the interval between each night's use. This sequence of events may account for two clinical findings reported to occur after several weeks of nightly use of other rapidly eliminated hypnotics, namely, increased wakefulness during the last third of the night, and the appearance of increased signs of daytime anxiety. Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with Ambien. Controlled trials supporting safety and efficacy Transient insomnia: Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings. Normal elderly adults (mean age 68) experiencing transient insomnia (n=35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality). Chronic insomnia: Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV™). Adult outpatients with chronic insomnia (n=75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate (10 and 15 mg) and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 15 mg was superior to placebo for all 5 weeks; zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied. Adult outpatients (n=141) with chronic insomnia were also evaluated in a double-blind, parallel group, 4-week trial comparing two doses of zolpidem (10 and 15 mg) and placebo. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week. Zolpidem 15 mg was superior to placebo on a subjective measure of sleep latency for the first 3 weeks, on a subjective measure of total sleep time for the first week, and on number of awakenings and sleep quality for the first 2 weeks. Next-day residual effects: Next-day residual effects of Ambien were evaluated in seven studies involving normal volunteers. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of Ambien in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness. Rebound effects: There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Ambien (zolpidem tartrate). There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg. Memory impairment: Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of Ambien. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), ie, these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of Ambien, predominantly at doses above 10 mg. Effects on sleep stages: In studies that measured the percentage of sleep time spent in each sleep stage, Ambien has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose. INDICATIONS AND USAGE Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia. Ambien has been shown to decrease sleep latency and increase the duration of sleep for up to 35 days in controlled clinical studies (see Clinical Pharmacology : Controlled trials supporting safety and efficacy ). Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if they are to be taken for more than 2 to 3 weeks. Ambien should not be prescribed in quantities exceeding a 1-month supply (see Warnings ). CONTRAINDICATIONS None known. WARNINGS Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness which should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including Ambien. Because some of the important adverse effects of Ambien appear to be dose related (see Precautions and Dosage and Administration ), it is important to use the smallest possible effective dose, especially in the elderly. A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (eg, aggressiveness and extroversion that seemed out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuro-psychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking, has been reported in association with the use of sedative/hypnotics. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. Following the rapid dose decrease or abrupt discontinuation of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs (see Drug Abuse and Dependence ). Ambien, like other sedative/hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, Ambien should only be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of Ambien. Ambien showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when Ambien is administered with such agents because of the potentially additive effects. PRECAUTIONS General Use in the elderly and/or debilitated patients: Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. Therefore, the recommended Ambien dosage is 5 mg in such patients (see Dosage and Administration ) to decrease the possibility of side effects. These patients should be closely monitored. Use in patients with concomitant illness: Clinical experience with Ambien (zolpidem tartrate) in patients with concomitant systemic illness is limited. Caution is advisable in using Ambien in patients with diseases or conditions that could affect metabolism or hemodynamic responses. Although studies did not reveal respiratory depressant effects at hypnotic doses of Ambien in normals or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90% was observed in patients with mild-to-moderate sleep apnea when treated with Ambien (10 mg) when compared to placebo. However, precautions should be observed if Ambien is prescribed to patients with compromised respiratory function, since sedative/hypnotics have the capacity to depress respiratory drive. Post-marketing reports of respiratory insufficiency, most of which involved patients with pre-existing respiratory impairment, have been received. Data in end-stage renal failure patients repeatedly treated with Ambien did not demonstrate drug accumulation or alterations in pharmacokinetic parameters. No dosage adjustment in renally impaired patients is required; however, these patients should be closely monitored (see Pharmacokinetics ). A study in subjects with hepatic impairment did reveal prolonged elimination in this group; therefore, treatment should be initiated with 5 mg in patients with hepatic compromise, and they should be closely monitored. Use in depression: As with other sedative/hypnotic drugs, Ambien should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time. Information for patients: Patient information is printed at the end of this insert. To assure safe and effective use of Ambien, this information and instructions provided in the patient information section should be discussed with patients. Laboratory tests: There are no specific laboratory tests recommended. Drug interactions CNS-active drugs: Ambien was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration. An additive effect on psychomotor performance between alcohol and zolpidem was demonstrated. A single-dose interaction study with zolpidem 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the zolpidem half-life. There was no evidence of an additive effect in psychomotor performance. Following five consecutive nightly doses of zolpidem 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem C max was significantly higher (43%) and T max was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem. Since the systematic evaluations of Ambien (zolpidem tartrate) in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with zolpidem. Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem. Drugs that affect drug metabolism via cytochrome P450: A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of zolpidem (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC 0>>(infinity) of zolpidem. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance. A randomized, placebo-controlled, crossover interaction study in eight healthy female volunteers between 5 consecutive daily doses of rifampin (600 mg) and a single dose of zolpidem (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (-73%), C max (-58%), and T 1/2 (-36%) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem. Other drugs: A study involving cimetidine/zolpidem and ranitidine/zolpidem combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem. Zolpidem had no effect on digoxin kinetics and did not affect prothrombin time when given with warfarin in normal subjects. Zolpidem's sedative/hypnotic effect was reversed by flumazenil; however, no significant alterations in zolpidem pharmacokinetics were found. Drug/Laboratory test interactions: Zolpidem is not known to interfere with commonly employed clinical laboratory tests. In addition, clinical data indicate that zolpidem does not cross-react with benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screens. Carcinogenesis, mutagenesis, impairment of fertility Carcinogenesis: Zolpidem was administered to rats and mice for 2 years at dietary dosages of 4, 18, and 80 mg/kg/day. In mice, these dosages are 26 to 520 times or 2 to 35 times the maximum 10-mg human dose on a mg/kg or mg/m 2 basis, respectively. In rats these doses are 43 to 876 times or 6 to 115 times the maximum 10-mg human dose on a mg/kg or mg/m 2 basis, respectively. No evidence of carcinogenic potential was observed in mice. Renal liposarcomas were seen in 4/100 rats (3 males, 1 female) receiving 80 mg/kg/day and a renal lipoma was observed in one male rat at the 18 mg/kg/ day dose. Incidence rates of lipoma and liposarcoma for zolpidem were comparable to those seen in historical controls and the tumor findings are thought to be a spontaneous occurrence. Mutagenesis: Zolpidem did not have mutagenic activity in several tests including the Ames test, genotoxicity in mouse lymphoma cells in vitro, chromosomal aberrations in cultured human lymphocytes, unscheduled DNA synthesis in rat hepatocytes in vitro, and the micronucleus test in mice. Impairment of fertility: In a rat reproduction study, the high dose (100 mg base/kg) of zolpidem resulted in irregular estrus cycles and prolonged precoital intervals, but there was no effect on male or female fertility after daily oral doses of 4 to 100 mg base/kg or 5 to 130 times the recommended human dose in mg/m 2 . No effects on any other fertility parameters were noted. Pregnancy Teratogenic effects: Pregnancy Category B. Studies to assess the effects of zolpidem on human reproduction and development have not been conducted. Teratology studies were conducted in rats and rabbits. In rats, adverse maternal and fetal effects occurred at 20 and 100 mg base/kg and included dose-related maternal lethargy and ataxia and a dose-related trend to incomplete ossification of fetal skull bones. Underossification of various fetal bones indicates a delay in maturation and is often seen in rats treated with sedative/hypnotic drugs. There were no teratogenic effects after zolpidem administration. The no-effect dose for maternal or fetal toxicity was 4 mg base/kg or 5 times the maximum human dose on a mg/m 2 basis. In rabbits, dose-related maternal sedation and decreased weight gain occurred at all doses tested. At the high dose, 16 mg base/kg, there was an increase in postimplantation fetal loss and underossification of sternebrae in viable fetuses. These fetal findings in rabbits are often secondary to reductions in maternal weight gain. There were no frank teratogenic effects. The no-effect dose for fetal toxicity was 4 mg base/kg or 7 times the maximum human dose on a mg/m 2 basis. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic effects: Studies to assess the effects on children whose mothers took zolpidem during pregnancy have not been conducted. However, children born of mothers taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born of mothers who received sedative/hypnotic drugs during pregnancy. Labor and delivery: Ambien (zolpidem tartrate) has no established use in labor and delivery. Nursing mothers: Studies in lactating mothers indicate that the half-life of zolpidem is similar to that in young normal volunteers (2.6 ± 0.3 hr). Between 0.004 and 0.019% of the total administered dose is excreted into milk, but the effect of zolpidem on the infant is unknown. In addition, in a rat study, zolpidem inhibited the secretion of milk. The no-effect dose was 4 mg base/kg or 6 times the recommended human dose in mg/m 2 . The use of Ambien in nursing mothers is not recommended. Pediatric use: Safety and effectiveness in pediatric patients below the age of 18 have not been established. Geriatric use: A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were >/=60 years of age. For a pool of U.S. patients receiving zolpidem at doses of /=70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were >/=70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg. ADVERSE REACTIONS Associated with discontinuation of treatment: Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse clinical event. Events most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse event. Events most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%). Data from a clinical study in which selective serotonin reuptake inhibitor- (SSRI) treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide. Incidence in controlled clinical trials Most commonly observed adverse events in controlled trials: During short-term treatment (up to 10 nights) with Ambien at doses up to 10 mg, the most commonly observed adverse events associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse events associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%). Adverse events observed at an incidence of >/=1% in controlled trials: The following tables enumerate treatment-emergent adverse event frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received Ambien in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied. The following table was derived from a pool of 11 placebocontrolled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. Incidence of Treatment-Emergent Adverse Experiences in Short-term Placebo-Controlled Clinical Trials (Percentage of patients reporting) Body System/ Adverse Event * Zolpidem ( drowsiness dizziness lightheadedness difficulty with coordination You may find that these medicines make you sleepy during the day. How drowsy you feel depends upon how your body reacts to the medicine, which sleep medicine you are taking, and how large a dose your doctor has prescribed. Daytime drowsiness is best avoided by taking the lowest dose possible that will still help you sleep at night. Your doctor will work with you to find the dose of Ambien that is best for you. To manage these side effects while you are taking this medicine: When you first start taking Ambien or any other sleep medicine until you know whether the medicine will still have some carryover effect in you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft. NEVER drink alcohol while you are being treated with Ambien or any sleep medicine. Alcohol can increase the side effects of Ambien or any other sleep medicine. Do not take any other medicines without asking your doctor first. This includes medicines you can buy without a prescription. Some medicines can cause drowsiness and are best avoided while taking Ambien. Always take the exact dose of Ambien prescribed by your doctor. Never change your dose without talking to your doctor first. SPECIAL CONCERNS There are some special problems that may occur while taking sleep medicines. Memory problems: Sleep medicines may cause a special type of memory loss or "amnesia." When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine. Memory loss can be a problem, however, when sleep medicines are taken while traveling, such as during an airplane flight and the person wakes up before the effect of the medicine is gone. This has been called "traveler's amnesia." Memory problems are not common while taking Ambien. In most instances memory problems can be avoided if you take Ambien only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems. Tolerance: When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as "tolerance." Sleep medicines should, in most cases, be used only for short periods of time, such as 1 or 2 days and generally no longer than 1 or 2 weeks. If your sleep problems continue, consult your doctor, who will determine whether other measures are needed to overcome your sleep problems. Dependence: Sleep medicines can cause dependence, especially when these medicines are used regularly for longer than a few weeks or at high doses. Some people develop a need to continue taking their medicines. This is known as dependence or "addiction." When people develop dependence, they may have difficulty stopping the sleep medicine. If the medicine is suddenly stopped, the body is not able to function normally and unpleasant symptoms (see Withdrawal ) may occur. They may find they have to keep taking the medicine either at the prescribed dose or at increasing doses just to avoid withdrawal symptoms. All people taking sleep medicines have some risk of becoming dependent on the medicine. However, people who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to sleep medicines. This possibility must be considered before using these medicines for more than a few weeks. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting Ambien or any sleep medicine. Withdrawal: Withdrawal symptoms may occur when sleep medicines are stopped suddenly after being used daily for a long time. In some cases, these symptoms can occur even if the medicine has been used for only a week or two. In mild cases, withdrawal symptoms may include unpleasant feelings. In more severe cases, abdominal and muscle cramps, vomiting, sweating, shakiness, and rarely, seizures may occur. These more severe withdrawal symptoms are very uncommon. Another problem that may occur when sleep medicines are stopped is known as "rebound insomnia." This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. If you should experience rebound insomnia, do not get discouraged. This problem usually goes away on its own after 1 or 2 nights. If you have been taking Ambien or any other sleep medicine for more than 1 or 2 weeks, do not stop taking it on your own. Always follow your doctor's directions. Changes in behavior and thinking: Some people using sleep medicines have experienced unusual changes in their thinking and/or behavior. These effects are not common. However, they have included: more outgoing or aggressive behavior than normal loss of personal identity confusion strange behavior agitation hallucinations worsening of depression suicidal thoughts How often these effects occur depends on several factors, such as a person's general health, the use of other medicines, and which sleep medicine is being used. Clinical experience with Ambien suggests that it is uncommonly associated with these behavior changes. It is also important to realize that it is rarely clear whether these behavior changes are caused by the medicine, an illness, or occur on their own. In fact, sleep problems that do not improve may be due to illnesses that were present before the medicine was used. If you or your family notice any changes in your behavior, or if you have any unusual or disturbing thoughts, call your doctor immediately. Pregnancy: Sleep medicines may cause sedation of the unborn baby when used during the last weeks of pregnancy. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Ambien. SAFE USE OF SLEEPING MEDICINES To ensure the safe and effective use of Ambien or any other sleep medicine, you should observe the following cautions: Ambien is a prescription medicine and should be used ONLY as directed by your doctor. Follow your doctor's instructions about how to take, when to take, and how long to take Ambien. Never use Ambien or any other sleep medicine for longer than directed by your doctor. If you notice any unusual and/or disturbing thoughts or behavior during treatment with Ambien or any other sleep medicine, contact your doctor. Tell your doctor about any medicines you may be taking, including medicines you may buy without a prescription. You should also tell your doctor if you drink alcohol. DO NOT use alcohol while taking Ambien or any other sleep medicine. Do not take Ambien unless you are able to get a full night's sleep before you must be active again. For example, Ambien should not be taken on an overnight airplane flight of less than 7 to 8 hours since "traveler's amnesia" may occur. Do not increase the prescribed dose of Ambien or any other sleep medicine unless instructed by your doctor. When you first start taking Ambien or any other sleep medicine until you know whether the medicine will still have some carryover effect in you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft. Be aware that you may have more sleeping problems the first night or two after stopping Ambien or any other sleep medicine. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Ambien. As with all prescription medicines, never share Ambien or any other sleep medicine with anyone else. Always store Ambien or any other sleep medicine in the original container out of reach of children. Ambien works very quickly. You should only take Ambien right before going to bed and are ready to go to sleep. sanofi~synthelabo Distributed by: Sanofi-Synthelabo Inc. New York, NY 10016 Ambien® CIV (zolpidem tartrate) Revised March 2004 Copyright, Sanofi- Synthelabo Inc. 2001, 2004 ZSS-5C PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. Zolpidem is a prescription drug used for the short-term treatment of insomnia (sleeping pill). It works quickly (usually within 15 minutes) and has a short half-life (2-3 hours), but will last longer in patients with hepatic failure. Some trade names of zolpidem are Ambien®, Stilnox®, Stilnoct®, Hypnogen® or Myslee®.[1] Its hypnotic effects are similar to those of the benzodiazepines, but it is actually classified as an imidazopyridine, and the anticonvulsant and muscle relaxant effects only appear at 10 and 20 times the dose required for sedation, respectively.[2] For that reason, it has never been approved for either muscle relaxation or seizure prevention. Such drastically increased doses are likely to induce one or more negative side effects, including hallucinations and/or amnesia. The patent in the United States on zolpidem is held by the French pharmaceutical corporation Sanofi-Aventis. The patent was due to expire in October 2006, but a six-month extension was granted, pushing the off-patent date to April 2007, so that Sanofi-Aventis can conduct further studies on the effects of zolpidem on children[3]. Zolpidem is available from several generic manufacturers in the UK, as generic from Sandoz in South Africa, as well as from other manufacturers such as Ratiopharm. Contents [hide] 1 Uses 2 Mechanism of action 3 Recreational use 4 Side-effects 5 See also 6 References 7 Notes [edit] Uses Zolpidem is approved for the short-term treatment of insomnia, but it has been studied for nightly use up to six months in a single-blind, open-label trial published in 1991[4], an open-label study lasting 180 days published in 1992 (with continued efficacy in patients who had kept taking it as of 180 days after the end of the trial)[5], and in an open-label trial lasting 179 days published in 1993[6]. The United States Air Force uses zolpidem under trade name Ambien® as "no-go pills" to help the pilots sleep after a mission; another drug used for the same purpose is temazepam (Restoril®).[7] (Cf. the "go-pills" amphetamine served under the name Dexedrine® act as a stimulant for the same pilots, ostensibly to reverse the effects of the "no-go pills," or its recent modafinil (Provigil®) replacement).[8] It is also used off-label to treat restless leg syndrome.[9] As is the case with many prescription sedative/hypnotic drugs, zolpidem is sometimes used by stimulant users to "come down" after the use of stimulants such as methamphetamine, cocaine, methylenedioxymethamphetamine (MDMA), or pharmaceutical amphetamines.[10] [edit] Mechanism of action In 1990, Pritchett and Seeburg noted that zolpidem binds with high affinity to the ?1, with medium affinity to the ?2, ?3-GABAA receptor subunits, and found that it had no affinity for the ?5 subunit.[11] Two years later, zolpidem was noted to have a high affinity for ?1; benzodiazepine receptors, a low affinity for ?2 and a very low affintity for ?3, respectively by Ruano et al in 1992.[12] In other words, it has the highest affinity for ?1 binding sites on ?-1GABAA receptor subunits, and it is this that mediates its sedative and weak anticonvulsant properties.[13] [edit] Recreational use Recreational use of this drug (specifically the Ambien® brand) is becoming more common in young people. Recreational users claim that "fighting" the effects of the drug by forcing themselves to stay awake will sometimes cause vivid visuals and a body high (see side-effects below.) Some recreational users report decreased anxiety, and even mild to moderate euphoria. The likelihood of experiencing any of these effects seems to be completely arbitrary regardless of the size of the dose. Recreational zolpidem use is speculated to lead to tolerance and dependence much more quickly than prescribed use. Recreational use is rising, as demonstrated by the use of street names for the pill, such as: "A-" (which is most likely due to the imprint on the Ambien CR® brand of zolpidem, which consists of a capital A along with a tilde, which looks roughly like A-, as well as for sedative and calming effects, "A+" is a street name for Adderall, named so because of its stimulant effects) and "zombie pills" (because of the waking sleep/sensory deprivation effect some users have reported experiencing). United States Congressman Patrick J. Kennedy (D-RI) was involved in a car crash in Washington, DC in May 2006, which he stated to police was caused by the effects of Ambien. Seth Putnam, founder and vocalist of grindcore band Anal Cunt took a ridiculous over-dosage of the pills, described as "two months worth of Ambien sleeping pills." [edit] Side-effects Larger doses of the drug can result in a variety of unwanted side effects: hallucinations, delusions, poor motor coordination, euphoria (though many instead report dysphoric reactions) increased appetite, increased sex drive, extremely poor judgment, difficulty maintaining physical balance, and, following use, inability to remember events that took place while under the influence of the drug (anterograde amnesia), especially why the patient took the drug in the first place. Some users take zolpidem recreationally for these side effects. However, it is not as common as benzodiazepine abuse because of its unique mental imagery (which can distract the user from reality without actually producing genuine hallucinations) and irrational behaviour combined with the amnesia. Accordingly, zolpidem can also become psychologically addictive if taken for extended periods of time, due to dependence on its ability to put one to sleep or to the unique sense of euphoria it can produce. Under the influence of the drug it is common to take more zolpidem than is necessary due to forgetting that one has already taken a pill[citation needed]. Users with a prediliction for abuse are advised to keep additional zolpidem in a safe place that the patient is unlikely to remember or be able to reach while intoxicated to avoid this risk. Before a user becomes fully acclimated to these effects (or if the user does not become acclimated), these symptoms can be severe enough to be deemed as drug-induced psychosis. Incidentally, antipsychotics like ziprasidone (Geodon) or quetiapine (Seroquel) may be prescribed alongside Ambien to both combat these side effects and to aid in sleep-induction, as they can also act as hypnotics. However, because some antidepressants are known for being mildly sedating (i.e., paroxetine), it may be advisable not to use zolpidem and an antidepressant simultaneously. Recently, zolpidem has been cited in various medical reports mainly in the United Kingdom as waking persistent vegetative state patients or PVS. More information is available on the BBC world news site under Zolpidem.[14] [edit] See also Alpidem [edit] References Ambien.com (2004). AMBIEN® Prescribing Information. Information About a Short-term Treatment for Insomnia - Ambien.com Home Page for Health-care Professionals. Sanofi-Synthelabo Inc. New York, NY 10016. Retrieved on 27 July 2005. STILNOX (zolpidem tartrate) PRODUCT INFORMATION Sanofi-Synthelabo Australia Pty Limited. 15 April 2004. [edit] Notes ^ Myslee® (zolpidem) to be launched in Japan Press Releases. Paris, December 11, 2000. Sanofi-Aventis. ^ Depoortere H, Zivkovic B, Lloyd KG, Sanger DJ, Perrault G, Langer SZ, Bartholini G. "Zolpidem, a novel nonbenzodiazepine hypnotic. I. Neuropharmacological and behavioral effects." Journal of Pharmacology and Experimental Therapeutics. 1986 May;237(2):649-58. PMID 2871178 ^ Schlich D, L'Heritier C, Coquelin JP, Attali P, Kryrein HJ. "Long-term treatment of insomnia with zolpidem: a multicentre general practitioner study of 107 patients." J Int Med Res. 1991 May-Jun;19(3):271-9. PMID 1670039 ^ Maarek L, Cramer P, Attali P, Coquelin JP, Morselli PL. "The safety and efficacy of zolpidem in insomniac patients: a long-term open study in general practice." J Int Med Res. 1992 Apr;20(2):162-70. PMID 1521672 ^ Kummer J, Guendel L, Linden J, Eich FX, Attali P, Coquelin JP, Kyrein HJ. "Long-term polysomnographic study of the efficacy and safety of zolpidem in elderly psychiatric in-patients with insomnia." J Int Med Res. 1993 Jul-Aug;21(4):171-84. PMID 8112475 ^ Caldwell JA, Caldwell JL. "Fatigue in military aviation: an overview of US military-approved pharmacological countermeasures." Aviation, Space, and Environmental Medicine. 2005 Jul;76(7 Suppl):C39-51. PMID 16018329 ^ see Caldwell et al., 1993. ^ Evidente, Virgilio Gerald H., Caviness, John N., and Adler, Charles H. "Case Studies in Movement Disorders." Seminars in Neurology. 23(3):277-284, 2003. Thieme Medical Publishers. 26 Jan 2004. Medscape Fulltext Thieme Fulltext PMID 14722823 ^ Pritchett DB, Seeburg PH. "Gamma-aminobutyric acidA receptor alpha 5-subunit creates novel type II benzodiazepine receptor pharmacology." Journal of Neurochemistry. 1990 May;54(5):1802-4. PMID 2157817 ^ Ruano D, Vizuete M, Cano J, Machado A, Vitorica J. "Heterogeneity in the allosteric interaction between the gamma-aminobutyric acid (GABA) binding site and three different benzodiazepine binding sites of the GABAA/benzodiazepine receptor complex in the rat nervous system." Journal of Neurochemistry. 1992 Feb;58(2):485-93. PMID 1309562 ^ Crestani F, Martin JR, Mohler H, Rudolph U. "Mechanism of action of the hypnotic zolpidem in vivo." British Journal of Pharmacology. 2000 Dec;131(7):1251-4. PMID 11090095 Fulltext ^ Angelettie M.S.W., Lisa. "Ambien Abuse" Fulltext Retrieved from "http://en.wikipedia.org/wiki/Zolpidem" Categories: Articles needing sources | Imidazopyridines | Anxiolytics | Schedule IV controlled substances Important safety information: AMBIEN is indicated for the short-term treatment of insomnia. There is a low occurrence of side effects associated with the short-term use of AMBIEN. The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). When you first start taking AMBIEN, use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication. In most instances, memory problems can be avoided if you take AMBIEN only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. As with any sleep medication, do not use alcohol while you are taking AMBIEN. Prescription sleep aids are often taken for 7 to 10 days — or longer as advised by your doctor. All people taking sleep medicines have some risk of becoming dependent on the medicine. For more information, please see important product information. Important safety information: AMBIEN CR is indicated for the treatment of insomnia. AMBIEN CR is one of many treatment options, in addition to lifestyle changes, that you and your doctor can consider. Until you know how AMBIEN CR will affect you, you shouldn’t drive or operate machinery. Side effects may include next day drowsiness, dizziness and headache. You shouldn’t take it with alcohol. All sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods of time without first talking to your doctor. Be sure you’re able to devote 7 to 8 hours to sleep before you need to be active again. For more information, please see important product information. Ambien This page contains drug information on Ambien. The information provided includes the following: what is Ambien the possible side effects of Ambien what happens if you miss a dose of Ambien what happens if you overdose with Ambien the most important information about Ambien how to use Ambien other drugs that may affect Ambien what to avoid while using Ambien Generic Name: zolpidem (zole PI dem) Brand Names: Ambien, Ambien CR What is the most important information I should know about zolpidem? • Use caution when driving, operating machinery, or performing other hazardous activities. Zolpidem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Zolpidem should be taken just before bedtime. You may experience some carryover effects the next day. • Do not drink alcohol while taking zolpidem. Alcohol will increase drowsiness and may increase dizziness while you are taking zolpidem, which could be dangerous. • Do not stop taking zolpidem suddenly if you have been taking it for more than 1 or 2 weeks. This may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with zolpidem. • Do not crush, chew, or break the controlled-release zolpidem tablets. Swallow the controlled-release tablets whole. What is zolpidem? • Zolpidem is in a class of drugs called sedative/ hypnotics or sleep medications. Zolpidem affects chemicals in your brain that may become unbalanced and cause insomnia. • Zolpidem induces sleep and causes relaxation. It is used to treat sleep disorders such as trouble falling asleep, waking up many times during the night, or waking up too early in the morning. Zolpidem is for short-term use only--usually 7 to 10 days. Longer-term use must be monitored closely by a doctor. • Zolpidem may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking zolpidem? • Before taking this medication, tell your doctor if you · have kidney disease; · have liver disease; · have asthma, bronchitis, emphysema, or another respiratory disease; or · are depressed or have suicidal thoughts. • You may not be able to take zolpidem, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. • Zolpidem is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take zolpidem without first talking to your doctor if you are pregnant or could become pregnant during treatment. • Zolpidem passes into breast milk and may affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. • If you are over 60 years of age, you may be more likely to experience side effects from zolpidem. You may require a lower dose of this medication. • Zolpidem is not approved by the FDA for use by children younger than 18 years of age. How should I take zolpidem? • Take zolpidem exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Take zolpidem just before you go to bed. It will make you drowsy, and you could fall and hurt yourself if you take your dose before you are ready for sleep. • Take zolpidem only if you are able to get a full night's sleep before you must be active again. • Do not take more of this medication than is prescribed for you. • Do not stop taking zolpidem suddenly if you have been taking it for more than 1 or 2 weeks. This may cause withdrawal symptoms and make you uncomfortable. Talk to your doctor if you need to stop treatment with zolpidem. • Do not crush, chew, or break the controlled-release zolpidem tablets. Swallow the controlled-release tablets whole. • Store zolpidem at room temperature away from moisture and heat. What happ