Zolpidem Tartrate 7.5 mg Capsule, 30-count — NDC 60290-089-01 (Billing 60290-0089-01)
This is a package of 30 capsules of Zolpidem Tartrate 7.5 mg Capsule from Umedica Laboratories USA Inc., marketed since May 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 60290-089-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 60290 labeler · 089 product · 01 package
- Package marketed since
- May 14, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0360290089018
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 084770
- GCN: 54147
- HICL (First Databank): 007842
- AHFS class code: 28:24.44.00
- RxCUI (RxNorm): 2637353
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the gamma-Aminobutyric Acid A Receptor Positive Modulator class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Zolpidem treats insomnia. Depending on the product, it helps you fall asleep, stay asleep, or get back to sleep after waking in the middle of the night. Most are meant for short-te...
- Take it right at bedtime, only when you can get a full 7 to 8 hours of sleep. Try not to take it with or right after a meal, since food can slow it down. Swallow extended-release t...
- No, please avoid it. Alcohol adds to drowsiness and can make your coordination and alertness worse. The same goes for other sedating medicines, so tell me everything you take.
- Zolpidem can cause next-day impairment even when you feel fine. Avoid driving or anything that needs full alertness if you took more than directed, had less than a full night to sl...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zolpidem Tartrate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60290-0089-01 You're viewing this Main listing | 30 CAPSULE in 1 BOTTLE | 2026-05-14 | — | Active |
| 60290-0089-02 60290-089-02 | 1000 CAPSULE in 1 BOTTLE | 2026-05-14 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
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What NDC number is used to bill for this package of Zolpidem Tartrate 7.5 mg Capsule?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| zolpidem tartrate 7.5 mg 52427-0775-30 | Almatica | 30 capsules | $7.933 | AB | Availability likely | — |
| Zolpidem Tartrate 7.5 mgthis 60290-0089-01 | Umedica | 30 capsules | — | AB | FDA listed | — |
| Zolpidem Tartrate 7.5 mg 13668-0775-30 | TORRENT | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Umedica Laboratories USA Inc. labeler code 60290
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 Capsules. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ].
WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Capsules. Some of these events may result in serious injuries, including death.
Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration (2.1) and Clinical Studies (14) ] . Zolpidem Tartrate Capsules, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than age 65 years of age ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Zolpidem Tartrate Capsules are only available in 7.5 mg strength. Use another zolpidem tartrate immediate-release product for 5 mg or 10 mg dosage ( 2.1 ) Avoid use of Zolpidem Tartrate Capsules in geriatric patients ( 2.1 ) Recommended dosage of zolpidem tartrate (use the lowest effective zolpidem tartrate dosage): Females: The recommended starting dosage of zolpidem tartrate immediate- release in females is 5 mg once nightly. Use another zolpidem tartrate immediate-release product for dosage initiation in females ( 2.1 , 2.2 , 8.6 ) Males: The recommended starting dosage of zolpidem tartrate immediate- release in males is either zolpidem tartrate immediate-release 5 mg, Zolpidem Tartrate Capsules 7.5 mg, or zolpidem tartrate immediate-release 10 mg, once nightly.
Use another zolpidem tartrate immediate-release product for 5 mg and 10 mg dosing ( 2.2 ) In both males and females: If a 5 mg nightly dose of another zolpidem tartrate immediate-release product is not effective, the zolpidem tartrate dosage may be increased to Zolpidem Tartrate Capsules 7.5 mg once nightly or 10 mg once nightly of another zolpidem tartrate immediate-release product. The maximum recommended dosage of zolpidem tartrate immediate-release is 10 mg once nightly ( 2.2 ) Zolpidem Tartrate Capsules are for short-term use only ( 2.3 ) Administer Zolpidem Tartrate Capsules orally once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.4 ) Zolpidem Tartrate Capsules should not be taken with or immediately after a meal.
Swallow whole. Do not open, crush, or chew ( 2.4 ) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Capsules ( 2.5 )
2.1Important Dosage Information Zolpidem Tartrate Capsules are only available in a 7.5 mg strength. Use another zolpidem tartrate immediate-release product for the 5 mg or 10 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products.
Zolpidem Tartrate Capsules are not indicated in geriatric patients . Avoid use of Zolpidem Tartrate Capsules in geriatric patients because the recommended dosage in these patients cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength [see Use in Specific Populations (8.5) ]. Use another zolpidem tartrate product for geriatric patients.
The recommended starting dosage for females is different than males because zolpidem clearance is lower in females [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. Do not use Zolpidem Tartrate Capsules to initiate zolpidem tartrate treatment in females because the recommended starting dosage in females cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength. Use another zolpidem tartrate immediate-release product to initiate treatment in females [see Dosage and Administration (2.2) ].
Avoid Zolpidem Tartrate Capsules in patients with mild or moderate hepatic impairment because the recommended dosage in such patients cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength [see Warnings and Precautions (5.8) , Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . Avoid any zolpidem tartrate use in patients with severe hepatic impairment because its use may contribute to encephalopathy [see Warnings and Precautions (5.8) , Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ].
2.2Recommended Dosage Use the lowest effective zolpidem tartrate dosage. For instructions on administration of Zolpidem Tartrate Capsules, see Dosage and Administration (2.4) . The recommended starting dosage of zolpidem tartrate immediate-release in females is 5 mg once nightly. Use another zolpidem tartrate immediate-release product for dosage initiation in females [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsules: 7.5 mg, Size 3, Opaque light green Cap and Opaque White body, imprinted with 'U4' on Cap & '7.5' on body in black ink, filled with white to off-white slug to granular powder. Capsules: 7.5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Zolpidem Tartrate Capsules are contraindicated in patients: who have experienced complex sleep behaviors after taking zolpidem [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 ( 4 ) Known hypersensitivity to zolpidem ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS CNS-Depressant Effects: Impaired 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: Reevaluate 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 capsules feasible to avoid intentional overdose ( 5.6 ) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function ( 5.7 ) Precipitation of Hepatic Encephalopathy: Avoid zolpidem tartrate in patients with severe hepatic impairment ( 2.1 , 5.8 , 8.7 ) Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation ( 5.9 , 9.3 )
5.1Complex 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 Capsules. 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 alone at recommended dosage, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions (7) ] .
Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior [see Contraindications (4) ] .
5.2CNS-Depressant Effects and Next-Day Impairment Zolpidem tartrate, like other sedative-hypnotic drugs, has CNS-depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression [see Drug Interactions (7) ] . Dosage adjustments of zolpidem tartrate and of other concomitant CNS depressants may be necessary when Zolpidem Tartrate Capsules are administered with such agents because of the potentially additive effects.
Use another zolpidem tartrate immediate-release product for the 5 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products. The use of Zolpidem Tartrate Capsules with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration (2.5) ].
The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpidem Tartrate Capsules are taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dosage is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if Zolpidem Tartrate Capsules are taken in these circumstances [see Dosage and Administration (2.5) , Clinical Studies (14.2) ].
Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sle…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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: headache, drowsiness, dizziness, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Umedica Laboratories USA Inc. at 1-855-288-5777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of Zolpidem Tartrate Capsules 7.5 mg for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults is based upon adequate and well-controlled studies of zolpidem tartrate tablets immediate-release [see Clinical Studies (14) ] .
The results of these adequate and well-controlled studies are presented below. Adverse Reactions Leading to Discontinuation of Treatment Approximately 4% of 1,701 patients who received zolpidem tartrate tablets immediate-release at all doses 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 tartrate tablets immediate-release at all doses 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 tartrate revealed that four of the seven discontinuations during double-blind treatment with zolpidem tartrate (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.
Most Commonly Observed Adverse Reactions in Controlled Trials During short-term treatment (up to 10 nights) with zolpidem tartrate tablets immediate-release at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem tartrate tablets immediate-release and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem tartrate-treated patients), dizziness (1%), and diarrhea (1%). Adverse Reactions Observed at an Incidence of ≥1% in Controlled Trials The following tables enumerate adverse reactions frequencies that were observed at an incidence equal to 1% or greater among zolpidem tartrate-treated patients with insomnia and at a greater incidence than placebo-treated patients in U.S. placebo-controlled trials.
Table 1 was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem tartrate tablets immediate-release. Table 1: Adverse Reactions (≥1% and > placebo) in Placebo-Controlled Clinical Trials Zolpidem Tartrate Tablets Immediate-Release Lasting up to 10 Nights (percentage of patients reporting) Body System Adverse Reaction Zolpidem Tartrate Tablets Immediate-Release (≤10 mg)* (N=685) % Placebo (N=473) % Central and Peripheral Nervous System Headache 7 6 Drowsiness 2 - Dizziness 1 - Gastrointestinal…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 2 presents clinically important drug interactions with zolpidem tartrate. Table 2: Clinically Important Drug Interactions with Zolpidem Tartrate Capsules Alcohol and Other CNS Depressants Clinical Impact Concomitant use of alcohol or other CNS depressants with zolpidem tartrate may lead to additive impairment of psychomotor performance and risk of CNS depression [see Clinical Pharmacology (12.3) ] . Intervention Dosage adjustments of Zolpidem Tartrate Capsules and of other concomitant CNS depressants may be necessary when Zolpidem Tartrate Capsules are coadministered because of the potentially additive effects.
Use another zolpidem tartrate immediate-release product for the 5 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products. The use of Zolpidem Tartrate Capsules with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration (2.5) , Warnings and Precautions ( 5.1 , 5.2 )] .
Opioids Clinical Impact Concomitant administration of zolpidem tartrate and opioids may increase the risk of respiratory depression [see Warnings and Precautions ( 5.2 , 5.7 )] . Intervention Limit dosage and duration of concomitant use of Zolpidem Tartrate Capsules and opioids, and monitor patients closely for respiratory depression. Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose (5 mg) [see Dosage and Administration (2.5) ] .
Imipramine and Chlorpromazine Clinical Impact Concomitant use of imipramine or chlorpromazine with zolpidem tartrate may lead to an additive effect of decreased alertness and psychomotor performance [see Clinical Pharmacology (12.3) ] . Intervention Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose (5 mg). Sertraline Clinical Impact Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see Clinical Pharmacology (12.3) ] .
Intervention Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose (5 mg). CYP3A4 Inducers Clinical Impact Concomitant use with CYP3A4 inducers may decrease zolpidem exposure [see Clinical Pharmacology (12.3) ] . Intervention Concomitant use of Zolpidem Tartrate Capsules and CYP3A4 inducers is not recommended.
CYP3A4 Inhibitors Clinical Impact Concomitant use with CYP3A4 inhibitors increased zolpidem exposure [see Clinical Pharmacology (12.3) ] . Intervention Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose. CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects.
Dose adjustment may be necessary ( 2.5 , 5.2 , 7 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7 ) Imipramine: Decreased alertness observed ( 7 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7 ) CYP3A4 inducers: Combination use may decrease effect ( 7 ) CYP3A4 inhibitors: Combination use may increase effect ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS 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 Capsule administration ( 8.2 ) Hepatic Impairment: Avoid use ( 2.1 , 8.7 ) 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 ( 5.5 , 8.4 )
8.1Pregnancy Risk Summary Neonates born to mothers using zolpidem tartrate 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 tartrate 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 theU.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 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 Capsules 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 tartrate during pregnancy do not report a clear association with zolpidem tartrate 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 tartrate during pregnancy. These cases required artificial ventilation or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.
Zolpidem tartrate has been shown to cross the placenta. Animal Data Oral administration of zolpidem tartrate to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended zolpidem tartrate human dose (MRHD) of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the MRHD based on mg/m 2 body surface area.
Oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the MRHD based on mg/m 2 body surface area. Oral administration of zolpidem tartrate to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the MRHD based on mg/m 2 body surface area.
8.2Lactation Risk Summary Limited data from published literature report the presence of zolpidem tartrate in human milk. There are reports of excess sedation in i…
🆘 Overdosage ▾
10 OVERDOSAGE 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. 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 tartrate'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 tartrate 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 tartrate is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of transient 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.
12.2Pharmacodynamics Zolpidem binds to GABA A receptors with greater affinity for α1 subunit relative to α2 and α3 subunit containing receptors. Zolpidem has no appreciable binding affinity for α5 subunit containing GABA A receptors. This binding profile may explain the relative absence of myorelaxant effects in animal studies.
Zolpidem has no appreciable binding affinity for dopaminergic D2, serotonergic 5HT2, adrenergic, histaminergic or muscarinic receptors.
12.3Pharmacokinetics Absorption Pharmacokinetics of zolpidem tartrate has been demonstrated to be linear between 5 mg and 20 mg (2 times the recommended dose of zolpidem tartrate (immediate-release). Following a single dose administration of 7.5 mg Zolpidem Tartrate Capsules and 10 mg zolpidem tartrate immediate-release tablets in healthy volunteers under fasted conditions: The mean dose-normalized peak plasma concentration (C max ) of zolpidem was 230 ng/mL for Zolpidem Tartrate Capsules and 218 ng/mL for 10 mg zolpidem tartrate immediate-release tablets.
The mean dose-normalized area under concentration curve (AUC) of zolpidem was 942 hour * ng/mL for Zolpidem Tartrate Capsules and 956 hour * ng/mL zolpidem tartrate immediate- release tablets. Effect of Food Mean zolpidem C max and AUC decreased by 39% and 8%, respectively, with a high-fat, high-calorie meal compared to fasted conditions following administration of Zolpidem Tartrate Capsules 7.5 mg to healthy volunteers. The median time to reach zolpidem C max (T max ) was prolonged from 1 hour to 2.8 hours post dose in the presence of food.
Distribution Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Elimination Metabolism Zolpidem tartrate is converted to inactive metabolites that are eliminated primarily by renal excretion. Excretion Following a single 7.5 mg dose of Zolpidem Tartrate Capsules under fasting state, the mean apparent clearance (CL/F) of the zolpidem tartrate was
15.72L/hr (range: 5.44 to 96.71), and the mean elimination half-life was 3.70 hours (range: 1.2 to 8.3 hours). Specific Populations Male and Female Patients At a given dose, zolpidem blood levels were higher in females compared to males. Females clear zolpidem tartrate from the body at a lower rate than males.
C max and AUC parameters of zolpidem tartrate were approximately 45% higher at the same dose in females compared with males [see Dosage and Administration (2.1) , Use in Specific Populations (8.6) ] . Patients with Hepatic Impairment The pharmacokinetics of zolpidem tartrate in eight patients with chronic hepatic impairment was compared to results in healthy subjects. Following a single 20 mg oral zolpidem tartrate 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 patients with chronic hepatic impairment.
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 subjects with normal hepatic function of 2.2 hr (range: 1.6 to 2.4 hr) [see Dosage and Administration (2.1) , Warnings and Precautions (5.8) , Use in Specific Populations (8.7) ] . Patients with Renal Impairment The pharmacokinetics of zolpidem tartrate was 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 tartrate 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 fir…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem Tartrate Capsules 7.5 mg, Size 3, Opaque light green Cap and Opaque White body, imprinted with 'U4' on Cap & '7.5' on body in black ink, filled with white to off-white slug to granular powder, and available as: NDC 60290-089-01, bottle of 30 capsules with child-resistant closure NDC 60290-089-02, bottle of 1000 capsules with child-resistant closure Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Zolpidem Tartrate Capsules 7.5 mg contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Chemically, zolpidem N,N,6-trimethyl-2- p -tolylimidazo[ 1,2-a ]pyridine-3-acetamide L(+)-tartrate). It has the following structure: Zolpidem tartrate is a white to off white powder, hygroscopic, that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride.
It has a molecular formula of (C 19 H 21 N 3 O) 2 · C 4 H 6 O 6 and molecular weight of 764.87 g/mol. Zolpidem Tartrate Capsules are intended for oral administration and are available only in a 7.5 mg strength. The capsules contain 7.5 mg zolpidem tartrate, USP (equivalent to 6 mg zolpidem) and include the following inactive ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac, sodium starch glycolate, strong ammonium solution, titanium dioxide, and the colorants FD&C blue #1, FD&C red #40, FD&C yellow #5. "Image Description"
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Complex Sleep Behaviors Instruct patients and their families that Zolpidem Tartrate Capsules may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes.
Tell patients to discontinue Zolpidem Tartrate Capsules and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] . CNS-Depressant Effects and Next-Day Impairment Advise patients that Zolpidem Tartrate Capsules has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness.
Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions (5.2) ] . Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem.
Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions (5.4) ] . Suicide Tell patients to immediately report any suicidal thoughts. Alcohol and other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription.
Advise patients not to use Zolpidem Tartrate Capsules if they drank alcohol that evening or before bed. Concomitant Use with Opioids Inform patients and caregivers that potentially serious additive effects may occur if Zolpidem Tartrate Capsules are used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.2 , 5.7 ), Drug Interactions (7) ] . Tolerance, Abuse, and Dependence Tell patients not to increase the dose of zolpidem tartrate on their own, and to inform you if they believe the drug "does not work." Administration Instructions Patients should be counseled to take Zolpidem Tartrate Capsules right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again.
Zolpidem Tartrate Capsules should not be taken with or immediately after a meal. Advise patients NOT to take Zolpidem Tartrate Capsules if they drank alcohol that evening. Lactation Advise breastfeeding mothers using Zolpidem Tartrate Capsules to monitor infants for increased sleepiness, breathing difficulties, or limpness.
Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating female may consider pumping and discarding breastmilk during treatment and for 23 hours after Zolpidem Tartrate Capsules administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2) ] . Manufactured by: Umedica Laboratories Pvt.
Ltd. Vapi, Gujarat 396195, India. Distributed by: Umedica Laboratories USA Inc.
Parsippany, NJ, 07054. Product of India 05/2026; V-00
💬 Medication Guide ▾
MEDICATION GUIDE ZOLPIDEM TARTRATE (zol pi dem tar trate) CAPSULES for oral use, CIV What is the most important information I should know about Zolpidem Tartrate Capsules? Zolpidem Tartrate Capsules may cause serious side effects, including: Complex sleep behaviors. After taking Zolpidem Tartrate Capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing.
The next morning, you may not remember that you did anything during the night. These activities may happen with Zolpidem Tartrate Capsules whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death.
People taking zolpidem tartrate have reported: sleep-walking sleep-driving making and eating food talking on the phone having sex Stop taking Zolpidem Tartrate Capsules and tell your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem Tartrate Capsules. What are Zolpidem Tartrate Capsules? Zolpidem Tartrate Capsules are a prescription sleep medicine used for the short-term treatment of adults younger than 65 years of age who have trouble falling asleep for a short period of time only (transient insomnia).
It is not known if Zolpidem Tartrate Capsules are safe and effective in children. Zolpidem Tartrate Capsules are not recommended for use in children or in adults over age 65. Zolpidem Tartrate Capsules are a federally controlled substance (CIV) because they can be abused or lead to dependence.
Keep Zolpidem Tartrate Capsules in a safe place to protect them from misuse and abuse and theft. Never give your Zolpidem Tartrate Capsules to anyone else because it may cause death or harm them. Selling or giving away Zolpidem Tartrate Capsules is against the law.
Do not take Zolpidem Tartrate Capsules if you: have had complex sleep behaviors that happened after taking zolpidem in the past. See “What is the most important information I should know about Zolpidem Tartrate Capsules?” are allergic to zolpidem or any of the ingredients in Zolpidem Tartrate Capsules. See the end of this Medication Guide for a complete list of ingredients in Zolpidem Tartrate Capsules.
Before taking Zolpidem Tartrate Capsules, tell your healthcare provider about all of your medical conditions, including if you: have a history of depression, mental illness, or suicidal thoughts or actions have a history of drug or alcohol abuse or addiction have kidney problems have liver problems. Zolpidem Tartrate Capsules should not be used in people with liver problems. have a lung disease or breathing problems have sleep apnea have myasthenia gravis are a female and are not currently taking another zolpidem tartrate medicine.
If you have never taken a zolpidem tartrate medicine before, your healthcare provider should prescribe another product to start zolpidem tartrate. are pregnant or plan to become pregnant. Taking Zolpidem Tartrate Capsules in the third trimester of pregnancy may harm your unborn baby. Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with Zolpidem Tartrate Capsules.
Taking Zolpidem Tartrate Capsules during your third trimester of pregnancy may cause your baby to have breathing problems and sedation (such as unusual sleepiness or limp muscles). are breastfeeding or plan to breastfeed. Zolpidem tartrate passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Zolpidem Tartrate Capsules.
If you breastfeed during treatment with Zolpidem Tartrate Capsules: call your healthcare provider or go to the nearest emergency room right away if your baby develops increased sleepiness, breathing problems, or limpness. to decrease the chance of your baby getting the medicine through your breast milk, you can pump and throw away your breast milk during treatment with Zolpidem…
Medicare Part D spend CMS · PART D · 2026 (Q1)
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| Active ingredient / dosage form / route | ✓ Available |
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