Label: ZOLPIDEM TARTRATE tablet, coated
- NDC Code(s): 80425-0513-1, 80425-0513-2, 80425-0513-3
- Packager: Advanced Rx of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0781-5317
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 18, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONZolpidem Tartrate Tablets - These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM ...
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Table of ContentsTable of Contents
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BOXED WARNING
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WARNING: COMPLEX SLEEP BEHAVIORS
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate tablets immediately if a patient experiences a complex sleep behaviors [see Contraindications ( 4) and Warnings and Precautions ( 5.1)].
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1 INDICATIONS AND USAGEZolpidem 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 Dosage in Adults - Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before ...
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3 DOSAGE FORMS AND STRENGTHSZolpidem tartrate tablets, USP are available in 5 mg and 10 mg strengths for oral administration. Tablets are not scored. Zolpidem tartrate tablets, USP 5 mg are white, round-shaped, biconvex ...
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4 CONTRAINDICATIONSZolpidem tartrate is contraindicated in patients - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets - [see Warnings and Precautions ( 5.1)] ...
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5 WARNINGS AND PRECAUTIONS5.1 Complex Sleep Behaviors - Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any ...
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6 ADVERSE REACTIONSThe following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors - [see Warnings and Precautions ( 5.1) ...
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7 DRUG INTERACTIONS7.1 CNS-Active Drugs - CNS Depressants - Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation ...
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9 DRUG ABUSE AND DEPENDENCE9.1 Controlled Substance - Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation. 9.2 Abuse - Abuse and addiction are separate and distinct from physical ...
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10 OVERDOSAGE10.1 Signs and Symptoms - In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence ...
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11 DESCRIPTIONZolpidem tartrate is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Zolpidem was administered to mice and rats for 2 years at oral doses of 4, 18, and 80 mg base/kg/day. In mice ...
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14 CLINICAL STUDIES14.1 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGZolpidem tartrate tablets, USP are available as follows: 5 mg, are white, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 5 on the other side. Bottles of 30 NDC ...
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17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with zolpidem tartrate tablets. Inform ...
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MEDICATION GUIDEMedication Guide - Zolpidem Tartrate Tablets, USP C-IV - for oral use - (ZOL-pih-dem) What is the most important information I should know about zolpidem tartrate tablets? Zolpidem ...
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Principal Display Panel - 5mg
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INGREDIENTS AND APPEARANCEProduct Information