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Quick facts
- How it is given
- oral
- Type
- human prescription drug
- RxNorm ID
- 854873
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
About this medicine
Zolpidem Tartrate Tablets, USP contains Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem Tartrate Tablets, USP 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 Zolpidem Tartrate Tablet, USP includes the following inactive ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate. The 10 mg tablets also contain Opadry II (white) and the 5 mg tablets contain Opadry II (pink). Opadry II (white) contains hypromellose, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Opadry II (pink) contains hypromellose, FD&C Red no. 40 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Test 3. Image
How it works
12.1 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 site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.
Who should not take it
Zolpidem Tartrate Tablets is contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets [see Warnings and Precautions ( 5.1 )] with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.4 )] Patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets ( 4 ) Known hypersensitivity to Zolpidem ( 4 )
Warnings and cautions
CNS-Depressant Effects: Impairs alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use. ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.4 ) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ( 5.5 ) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose. ( 5.6 ) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ( 5.7 ) Hepatic Impairment: Avoid Zolpidem Tartrate Tablets use in patients with severe hepatic impairment. ( 5.8 ) Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation. ( 5.9 , 9.3 ) 5.1 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 subsequent use of Zolpidem Tartrate Tablets. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with Zolpidem Tartrate Tablets alone at recommended doses, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interaction ( 7.1 )]. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 )]. […]
Reported side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions ( 5.1 )] CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.2 )] Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions ( 5.4 )] Abnormal thinking and behavior changes [see Warnings and Precautions ( 5.5 )] Withdrawal effects [see Warnings and Precautions ( 5.9 )] Most commonly observed adverse reactions were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28-35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ACI Healthcare USA, Inc. at 1- 888-802-1213.or www.acihealthcareusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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 reaction. Reactions 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 reaction. Reactions 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. […]
Interactions with other medicines
depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2 ) Ketoconazole: Combination use may increase effect ( 7.2 ) 7.1 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 drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions ( 5.1 , 5.2 )]. Zolpidem Tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Alcohol An additive adverse effect on psychomotor performance between alcohol and oral Zolpidem was demonstrated [see Warnings and Precautions ( 5.1 , 5.2 )] Opioids The concomitant use of Zolpidem Tartrate Tablets with opioids may increase the risk of respiratory depression. Limit dosage and duration of concomitant use of Zolpidem Tartrate Tablets and opioids [ see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.7 )] Imipramine, Chlorpromazine 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 [see Clinical Pharmacology ( 12.3 )]. Sertraline Concomitant administration of Zolpidem and sertraline increases exposure to Zolpidem [see Clinical Pharmacology ( 12.3 )]. Fluoxetine After multiple doses of Zolpidem Tartrate and fluoxetine an increase in the Zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance [see Clinical Pharmacology ( 12.3 )]. […]
Use in specific groups
Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. ( 8.1 ) Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after Zolpidem Tartrate Tablets administration. ( 8.2 ) Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. ( 5.4 , 8.4 ) 8.1 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 [see Clinical Considerations and Data]. Published data on the use of Zolpidem during pregnancy have not reported a clear association with Zolpidem and major birth defects [see Data]. Oral administration of Zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to Zolpidem Tartrate Tablets during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. Data Human data Published data from observational studies, birth registries, and case reports on the use of Zolpidem during pregnancy do not report a clear association with Zolpidem and major birth defects. There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken Zolpidem during pregnancy. […]
If too much is taken
10.1 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 to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported. 10.2 Recommended Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following Zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that Zolpidem is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 16 November 2023. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.