![]() ![]() These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic.ĩ.3 Dependence Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. 2.4 Administration The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.ĩ.2 Abuse Abuse and addiction are separate and distinct from physical dependence and tolerance. 2.3 Use with CNS Depressants Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects. Avoid zolpidem tartrate use in patients with severe hepatic impairment as it may contribute to encephalopathy. The recommended dose of zolpidem tartrate in these patients is 5 mg once daily immediately before bedtime. Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. 2.2 Special Populations Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended initial doses for women and men are different because zolpidem clearance is lower in women. Zolpidem tartrate tablets should be taken as a single dose and should not be readministered during the same night. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. ![]() ![]() If the 5 mg dose is not effective, the dose can be increased to 10 mg. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. at 1-85 email or FDA at 1-80 or 2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily (2.1) Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening (2.1) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate tablets (2.3) The effect of zolpidem tartrate tablets may be slowed if taken with or immediately after a meal (2.4) 2.1 Dosage in Adults Use the lowest effective dose for the patient. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. Withdrawal effects Most commonly observed adverse reactions were: Short-term ( 2x ULN, alkaline phosphatase ≥ 2x ULN, transaminase ≥ 5x ULN).Abnormal thinking and behavior changes, and complex behaviors.Serious anaphylactic and anaphylactoid reactions.CNS-depressant effects and next-day impairment.6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: ![]()
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