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Zolpidem Tartrate 7.5 mg Capsule, 1,000-count — NDC 60290-0089-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zolpidem Tartrate 7.5 mg Capsule, 1,000-count — NDC 60290-089-02 (Billing 60290-0089-02)

by Umedica Laboratories USA Inc. · 1000 CAPSULE in 1 BOTTLE

This is a package of 1,000 capsules of Zolpidem Tartrate 7.5 mg Capsule from Umedica Laboratories USA Inc., marketed since May 2026 and currently FDA-listed.

NDC 60290-0089-02
🏷️ FDA NDC (as labeled) 60290-089-02 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Product page 60290-0089-01 Also comes in: 30 capsules 60290-089-01
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60290-089-02
Product NDC 60290-089
11-digit billing NDC 60290008902
RxCUI 2637353
UNII WY6W63843K
UPC 0360290089018
Application # ANDA220717
SPL Set ID b49f6c18-e155-4728-a79a-9354e8c3c8f4
Established class (EPC) gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of action GABA A Receptor Positive Modulators
Physiologic effect Central Nervous System Depression
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-14
Route ORAL
Dosage form CAPSULE
Substance ZOLPIDEM TARTRATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 084770
GCN 54147
HICL code 007842
Ingredient (HICL) Zolpidem Tartrate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 28:24.44.00
AHFS class Non-Benzodiazepine Hypnotics
FDB label name ZOLPIDEM TARTRATE 7.5 MG CAP
FDB brand name Zolpidem Tartrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084770
  • GCN: 54147
  • HICL (First Databank): 007842
  • AHFS class code: 28:24.44.00
  • RxCUI (RxNorm): 2637353
Why two NDCs? The FDA registers this code as 60290-089-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 60290-0089-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the gamma-Aminobutyric Acid A Receptor Positive Modulator class.

Pharmacologic class gamma-Aminobutyric Acid A Receptor Positive Modulator
Drug family (ATC) Benzodiazepine related drugs
How it works GABA A Receptor Positive Modulators
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ZOLPIDEM TARTRATE 7.5 MG CAP Ingredient Zolpidem Tartrate
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Zolpidem guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60290-0089-01 60290-089-01 Main listing 30 CAPSULE in 1 BOTTLE 2026-05-14 — Active
60290-0089-02 You're viewing this 1000 CAPSULE in 1 BOTTLE 2026-05-14 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 capsule in 1 bottle.
How does this package differ from NDC 60290-0089-01?
Both are Zolpidem Tartrate 7.5 mg Capsule — the drug itself is identical. This page's package is the 1,000-count one, while NDC 60290-0089-01 is the 30 capsules package.
What NDC number is used to bill for this package of Zolpidem Tartrate 7.5 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
zolpidem tartrate 7.5 mg 52427-0775-30 Almatica 30 capsules $7.933 AB Availability likely —
Zolpidem Tartrate 7.5 mgthis 60290-0089-02 Umedica 1000 capsules — AB FDA listed —
Zolpidem Tartrate 7.5 mg 13668-0775-30 TORRENT 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color green / white
ShapeCapsule
ImprintU4
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerUmedica Laboratories USA Inc.
Application holderUMEDICA LABORATORIES PVT LTD
FDA applicationANDA220717 (ANDA)
Labeler code60290
First marketedMay 2026
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio52 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 124 words ▾

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 79 words ▾

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 ~3 min read ▾

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.… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 45 words ▾

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 62 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 205 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 84 words ▾

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 165 words ▾

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 ~2 min read ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Transient Insomnia The efficacy of Zolpidem Tartrate Capsules for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adult patients younger than 65 years of age is based upon adequate and well-controlled studies of zolpidem tartrate tablets (immediate-release). The results of these adequate and well-controlled studies of zolpidem tartrate tablets are presented below. 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 comparing two doses of zolpidem tartrate tablets (7.5 mg and 10 mg) and placebo.

Both zolpidem tartrate doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.

14.2Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs Next-Day Residual Effects Next-day residual effects of zolpidem tartrate were evaluated in seven studies involving healthy subjects. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects (Zolpidem Tartrate Capsules are not indicated in geriatric patients, see Use in Specific Populations (8.5) ) , a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo.

Studies of zolpidem tartrate in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness. Rebound Effects There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate. There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the 5 mg (Zolpidem Tartrate Capsules is not indicated in geriatric patients, see Use in Specific Populations (8.5) ) .

Memory Impairment Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of zolpidem tartrate. However, in one study involving zolpidem doses of 10 mg and 20 mg (2 times the maximum recommended zolpidem tartrate immediate-release dose), there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post dose), i.e., these subjects experienced anterograde amnesia.

There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of zolpidem tartrate, predominantly at doses above the maximum recommended zolpidem tartrate dose of 10 mg. Effects on Sleep Stages In studies that measured the percentage of sleep time spent in each sleep stage, zolpidem tartrate has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Zolpidem Tartrate Capsules contain zolpidem tartrate, a Schedule IV controlled substance.

9.2Abuse Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom is was not prescribed.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg (4 times the maximum recommended dosage for zolpidem tartrate immediate-release) were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo.

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 tartrate, they should be monitored carefully when receiving Zolpidem Tartrate Capsules.

9.3Dependence Use of Zolpidem Tartrate Capsules may lead to the development of physical and/or psychological dependence. The risk of dependence increases with dose and duration of treatment. The risk of abuse and dependence is also greater in patients with a history of alcohol or drug abuse.

Zolpidem Tartrate Capsules should be used with extreme caution in patients with current or past alcohol or drug abuse. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, convulsions, and delirium. The following adverse reactions, which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal, were reported during clinical trials with another zolpidem tartrate immediate-release product following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort.

These reported adverse reactions occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. There have been postmarketing reports of abuse, dependence and withdrawal with zolpidem.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, 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, these doses are approximately 2.5, 10, and 50 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area and in rats, these doses are approximately 5, 20, and 100 times the MRHD based on mg/m 2 body surface area. No evidence of carcinogenic potential was observed in mice.

In rats, renal tumors (lipoma, liposarcoma) were seen at the mid and high doses. Mutagenesis Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and in vivo (mouse micronucleus) genetic toxicology assays. Impairment of Fertility Zolpidem was administered to rats 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, prior to and during mating, and continuing in females through postpartum day 25.

Zolpidem caused irregular estrus cycles and prolonged precoital intervals at the highest dose tested, which is approximately 120 times the MRHD based on mg/m 2 body surface area. The NOAEL for these effects is 25 times the MRHD based on a mg/m 2 body surface area. There was no impairment of fertility at any dose tested.

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANEL Zolpidem Tartrate Capsules 7.5 mg - NDC 60290-089-01 - 30 Caps Bottle Label Zolpidem Tartrate Capsules 7.5 mg - NDC 60290-089-02 - 1000 Caps Bottle Label "Image Description" "Image Description"

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zolpidem Tartrate — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zolpidem Tartrate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.85M
Claims incl. refills
1.9M
Beneficiaries
1M
Spend / beneficiary
$12.81
Spend / claim
$6.71
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Umedica Laboratories USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (60290-0089-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Umedica Laboratories USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 60290-0088-01 · Umedica 60290-0095-01 · Umedica →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.