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Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1)
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Recent Major Changes Section
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Indications and Usage (1) 03/2007 Warnings and Precautions (5) 03/2007
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2 Dosage And Administration
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Adult dose: 10 mg immediately before bedtime (2.1) Elderly/Debilitated patients/Hepatic Impairment: Initial dose of 5 mg (2.2) Downward dosage adjustment may be necessary when used with CNS depressants (2.3) Total daily dose should not exceed 10 mg (2.4)
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3 Dosage Forms And Strengths
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5 mg and 10 mg tablets (3)
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Hypersensitivity to zolpidem tartrate or inactive ingredients (4.1)
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5 Warnings And Precautions
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Reevaluate if insomnia persists after 7 to 10 days of use (5.1) Severe anaphylactic and anaphylactoid reactions have been reported (5.2) Abnormal thinking, behavior changes and complex behaviors such as sleep-driving have been reported (5.3) Pediatric patients with attention-deficit/hyperactivity disorder (ADHD): Hallucinations (7.4%) and other psychiatric and /or nervous system adverse events were observed frequently (5.6, 8.4) Depression: Worsening of depression or, suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose (5.3, 5.6) Withdrawal symptoms may occur with rapid dose reduction or discontinuation (5.4) CNS depressant effects, additive effects with CNS depressants (2.3, 5.5) Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug and the following day (5.5) Additive effects with alcohol; should not be taken with alcohol (5.5) Elderly/debilitated patients: Impaired motor, cognitive performance after repeated exposure, increased sensitivity (2.2, 5.6) Caution advised in patients with hepatic impairment, mild to moderate COPD, impaired drug metabolism or hemodynamic responses, mild to moderate sleep apnea (5.6)
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Most commonly observed adverse events in studies with zolpidem (up to 10 mg) at statistically significant differences from placebo were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28 - 35 nights): Dizziness and drugged feelings (6.1) Dose relationship observed for adverse events especially CNS and GI events (6.1) Other adverse reactions, including serious adverse reactions, have been reported (6)
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Imipramine: decreased alertness (7.1) Chlorpromazine: impaired alertness and psychomotor performance (7.1) Alcohol causes additive psychomotor impairment (7.1) Rifampin (CYP450) decreases exposure to, and effects of zolpidem (7.2) Sedative/hypnotic effect reversed by flumazenil (7.3, 10.2)
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8 Use In Specific Populations
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Labor and delivery: No established use (8.2) Nursing mothers: Not recommended (8.3) Pediatric use: Safety and effectiveness have not been established (8.4) Geriatric use: Reduced dose in elderly to decrease side effects (8.5)
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9 Drug Abuse And Dependence
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Created by
fda_medical_bot
on
1/7/2012
