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ZOLPIDEM TARTRATE 10 mg Tablet, 30-count

by NuCare Pharmaceuticals, Inc · 30 TABLET in 1 BOTTLE (68071-1887-3)

NDC 68071-1887-03

🏷️ FDA NDC (as labeled) 68071-1887-3 billing pads the package segment with a zero

This package

Contains30-count Pack sizes8 compare ↓

Also priced by: Part D plans $0.1631/unit — full pricing hub ↓

Also comes in: 10 tablets 68071-1887-01 14 tablets 68071-1887-04 15 tablets 68071-1887-05 20 tablets 68071-1887-02 28 tablets 68071-1887-08 60 tablets 68071-1887-06 90 tablets 68071-1887-09

Rx only Generic On market CIV

🗂️ Data synced 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 68071-1887-3

Product NDC 68071-1887

11-digit billing NDC 68071188703

RxCUI 854873

UNII WY6W63843K

UPC 0368071188790

Application # ANDA077903

SPL Set ID 4be6ce23-e7b1-510e-e054-00144ff8d46c

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 2007-09-05

Route ORAL

Dosage form TABLET

Substance ZOLPIDEM TARTRATE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68071-1887-3 — a 5-4-1 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 package segment → 68071-1887-03. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals, Inc

Application holderTORRENT PHARMACEUTICALS LTD

FDA applicationANDA077903 (ANDA)

Labeler code68071

First marketedSep 2007

DEA scheduleCIV

Product typeHuman Prescription Drug

Portfolio3 products on file

🔎 All NDCs from NuCare Pharmaceuticals, Inc

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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Zolpidem is a prescription sleep medicine for insomnia. Depending on which form your doctor prescribed, it can help you fall asleep faster at bedtime, sleep through the night witho...
What exactly is zolpidem supposed to do for me?
This is one of the most important things to know: zolpidem can impair your driving and mental sharpness the next morning, even if you feel wide awake and fine. The risk goes up if...
Is it safe to drive to work the morning after taking zolpidem?

📖 Read our full Zolpidem guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Zolpidem Tartrate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Zolpidem Tartrate (195 interactions) — ranked by severity →

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.

💊 What it looks like

Color yellow

ShapeCapsule

Imprint10MG

Size1 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 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.

1 inactive ingredient 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.

💲 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 · Q2 2026	$0.1631	$4.89 / 30 tablets

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Zolpidem Tartrate 10 mg 00781-5318-01	Sandoz	100 tablets	$0.039	AB	Availability likely	—
Zolpidem Tartrate 10 mg 13668-0008-01	Torrent	100 tablets	$0.039	AB	Availability likely	—
Zolpidem Tartrate 10 mg 16714-0622-01	NorthStar	100 tablets	$0.039	AB	Availability likely	—
Zolpidem Tartrate 10 mg 62135-0779-90	Chartwell	90 tablets	$0.039	AB	Availability likely	—
Zolpidem Tartrate 10 mg 65862-0160-01	Aurobindo	100 tablets	$0.039	—	Availability likely	—
Zolpidem 10 mg 71093-0156-04	ACI	100 tablets	$0.039	AB	Availability likely	—
Ambien 10 mg 00024-5421-31	Sanofi-Aventis	100 tablets	$22.631	AB	Availability likely	—
Ambien 10 mg 00713-5421-01	Cosette	100 tablets	$22.631	AB	Availability likely	—
Zolpidem Tartrate 10 mg 17224-0970-30	Calvin	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 50090-3878-00	A-S	10 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 50090-5095-00	A-S	90 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 50090-5804-00	A-S	90 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 50090-6070-00	A-S	10 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 51407-0878-01	Golden	100 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 51407-0942-01	Golden	100 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 55700-0357-30	Lake	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 60760-0288-30	St.	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 61919-0663-30	DirectRX	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 63187-0565-15	Proficient	15 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 63187-0682-15	Proficient	15 tablets	—	—	FDA listed	—
Zolpidem Tartrate 10 mg 63187-0690-15	Proficient	15 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 63629-1171-01	Bryant	100 tablets	—	AB	Discontinued	—
Zolpidem 10 mg 63629-8999-01	Bryant	30 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 63629-9614-01	Bryant	1000 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mgthis 68071-1887-03	NuCare	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 68071-3770-09	NuCare	90 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 68071-5063-09	NuCare	90 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 68071-5093-01	NuCare	10 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 68071-5120-01	NuCare	100 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 68788-9127-02	Preferred	28 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 70518-3739-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 70518-3943-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 71205-0691-30	Proficient	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 71335-0154-00	Bryant	5 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 71335-2303-01	Bryant	1000 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 71335-9684-00	Bryant	5 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 71610-0152-10	Aphena	10 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 71610-0192-15	Aphena	15 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 71610-0848-10	Aphena	10 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 71610-0915-10	Aphena	10 tablets	—	AB	FDA listed	—
Zolpidem 10 mg 72162-1983-01	Bryant	100 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 72722-0104-01	The	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 72789-0323-01	PD-Rx	100 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 76420-0263-30	Asclemed	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 76420-0417-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 80425-0059-01	Advanced	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 80425-0060-01	Advanced	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 80425-0061-01	Advanced	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 80425-0153-01	Advanced	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 80425-0301-01	Advanced	30 tablets	—	AB	Discontinued	—
Zolpidem Tartrate 10 mg 82868-0064-30	Northwind	30 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 82868-0078-30	Northwind	30 tablets	—	AB	FDA listed	—
Edluar 10 mg 00037-6010-02	Viatris	40 tablets	—	AB	FDA listed	—
Zolpidem Tartrate 10 mg 50090-1023-00	A-S	10 tablets	—	AB	Discontinued	—

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

🏛️

2007

On the market since

Sep 2007

📍

2026

Currently FDA-listed

19 years listed

🔓

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.

📊 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

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zolpidem Tartrate — the ingredient across all brands.

Top reported reactions

Nausea8,545

Fatigue8,298

Pain6,491

Insomnia6,338

Headache6,332

Diarrhoea5,966

Fall5,637

Age at onset

Neonate147

Infant18

Child24

Adolescent99

Adult11,820

Elderly6,797

Reporter sex

Male · 36%

Female · 64%

Unknown · 0%

Serious outcomes

Hospitalization46,186

Death15,985

Life-threatening6,176

Disabling3,734

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
68071-1887-01	10 TABLET in 1 BOTTLE (68071-1887-1)	2017-03-29	Active
68071-1887-02	20 TABLET in 1 BOTTLE (68071-1887-2)	2017-03-29	Active
68071-1887-03 You're viewing this	30 TABLET in 1 BOTTLE (68071-1887-3)	2017-03-29	Active
68071-1887-04	14 TABLET in 1 BOTTLE (68071-1887-4)	2017-03-29	Active
68071-1887-05	15 TABLET in 1 BOTTLE (68071-1887-5)	2017-03-29	Active
68071-1887-06	60 TABLET in 1 BOTTLE (68071-1887-6)	2017-03-29	Active
68071-1887-08	28 TABLET in 1 BOTTLE (68071-1887-8)	2017-03-29	Active
68071-1887-09	90 TABLET in 1 BOTTLE (68071-1887-9)	2017-03-29	Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68071-1887-03?

NDC 68071-1887-03 is a 30-count package — 30 tablet in 1 bottle.

What is the difference between NDC 68071-1887-03 and NDC 68071-1887-01?

Both are ZOLPIDEM TARTRATE 10 mg Tablet — the drug itself is identical. NDC 68071-1887-03 is the 30-count package, while NDC 68071-1887-01 is the 10 tablets package.

What NDC number is used to bill for this package of ZOLPIDEM TARTRATE 10 mg Tablet?

Bill NDC 68071-1887-03 — the 11-digit billing format is 68071188703. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 68071-1887-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68071-1887-03, written without dashes as 68071188703. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 68071-1887-03, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals, Inc; the middle segment (1887) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.

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 NuCare Pharmaceuticals, 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 7 other package presentations of this same product, including 10 tablets (68071-1887-01), 14 tablets (68071-1887-04), 15 tablets (68071-1887-05). 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?

NuCare Pharmaceuticals, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 101 words ▾

1 INDICATIONS AND USAGE Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A agonist, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14) ] .

The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily (2.1) Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening (2.1) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate tablets (2.3) The effect of zolpidem tartrate tablets may be slowed if taken with or immediately after a meal (2.4)

2.1Dosage in Adults Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg.

In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime. Zolpidem tartrate tablets should be taken as a single dose and should not be readministered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

2.2Special Populations Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of zolpidem tartrate in these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1), Use in Specific Populations (8.5)]. Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects.

The recommended dose of zolpidem tartrate tablets in these patients is 5 mg once daily immediately before bedtime. Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.3Use with CNS Depressants Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)] .

2.4Administration The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

💊 Dosage Forms and Strengths 88 words ▾

3 DOSAGE FORMS AND STRENGTHS 5 mg and 10 mg tablets. Tablets not scored. Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration.

Tablets are not scored. Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and '5 MG' debossed on the other side. Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and '10 MG' debossed on the other side.

⛔ Contraindications 30 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to zolpidem Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CNS depressant effects: Impairs alertness and motor coordination. Instruct patients on correct use. (5.1) Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia persists after 7 to 10 days of use.

(5.2) Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. (5.3) "Sleep-driving" and other complex behaviors while not fully awake.

Risk increases with dose and use with other CNS depressants and alcohol. Immediately evaluate any new onset behavioral changes. (5.4) Depression: Worsening of depression or suicidal thinking may occur.

Prescribe the least amount of tablets feasible to avoid intentional overdose. (5.5) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function (5.6) Hepatic Impairment: Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment. (5.7) Withdrawal effects: Symptoms may occur with rapid dose reduction or discontinuation (5.8, 9.3) Severe Injuries: Drowsiness may lead to fall including severe injuries (5.9)

5.1CNS Depressant Effects and Next-Day Impairment Zolpidem tartrate tablets, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of zolpidem tartrate tablets and of other concomitant CNS depressants may be necessary when zolpidem tartrate tablets are administered with such agents because of the potentially additive effects.

The use of zolpidem tartrate tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration (2.3)]. The risk of next-day psychomotor impairment, including impaired driving, is increased if zolpidem tartrate tablets are taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or if co-administered 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 tablets are taken in these circumstances [see Dosage and Administration (2) and Clinical Studies (14.3)]. 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, sleepiness, blurred/double vision, reduced alertness and impaired driving the morning after therapy. In order to minimize this risk a full night of sleep (7-8 hours) is recommended.

5.2Need to Evaluate for Co-morbid Diagnoses Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder.

Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.

5.3Severe Anaphylactic and Anaphylactoid Reactions Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department.

If angioedema involves the throat, glottis or l…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most commonly observed adverse reactions were: Short-term (< 10 nights): Drowsiness, dizziness, and diarrhea Short-term (< 10 nights): Drowsiness, dizziness, and diarrhea Long-term (28 - 35 nights): Dizziness and drugged feelings ( ) Long-term (28 - 35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma, Inc. at 1-269-544-2299 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch The following serious adverse reactions are discussed in greater detail in other sections of the labeling: CNS-depressant effects and next-day impairment [see Warnings and Precautions (5.1)] Serious anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.3)] Abnormal thinking and behavior changes, and complex behaviors [see Warnings and Precautions (5.4)] Withdrawal effects [see Warnings and Precautions (5.8)]

6.1Clinical Trials Experience Associated with discontinuation of treatment: Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction.

Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%). Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.

Most commonly observed adverse reactions in controlled trials: During short-term treatment (up to 10 nights) with zolpidem tartrate tablets at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

Adverse reactions observed at an incidence of ≥ 1% in controlled trials: The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population st…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects (5.1, 7.1) Imipramine: Decreased alertness observed (7.1) Chlorpromazine: Impaired alertness and psychomotor performance observed (7.1) CYP3A4 inducers (e.g. rifampin): Combination use may decrease effect (7.2) CYP3A4 inhibitors (e.g. ketoconazole): Combination use may increase effect (7.2)

7.1CNS-active Drugs Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability. [see Warnings and Precautions (5.1)]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.

Imipramine, Chlorpromazine Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [see Clinical Pharmacology (12.3)] . Haloperidol A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem.

The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration [see Clinical Pharmacology (12.3)] . Alcohol An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1)] . Sertraline Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see Clinical Pharmacology (12.3)] .

Fluoxetine After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance [see Clinical Pharmacology (12.3)] .

7.2Drugs that Affect Drug Metabolism via Cytochrome P450 Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of drugs that induce or inhibit other P450 enzymes on the exposure to zolpidem is not known. CYP3A4 Inducers Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem.

Use of CYP3A4 inducers in combination with zolpidem may decrease the efficacy of zolpidem [see Clinical Pharmacology (12.3)] . CYP3A4 Inhibitors Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together [see Clinical Pharmacology (12.3)] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1) Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder (5.4, 8.4)

8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period.

Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Zolpidem should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the zolpidem tartrate tablets maximum recommended human dose (MRHD) of 10 mg/day (approximately 8 mg/day zolpidem base); however, teratogenicity was not observed.

When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg/day to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m 2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg/day increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose tested. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 10 times the MRHD on a mg/m 2 basis.

Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m 2 basis.

8.2Labor and Delivery Zolpidem tartrate tablets have no established use in labor and delivery [see Pregnancy (8.1) ].

8.3Nursing Mothers Zolpidem is excreted in human milk. Caution should be exercised when zolpidem is administered to a nursing woman.

8.4Pediatric Use Zolpidem is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. In an 8-week study, in pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo.

Psychiatric and nervous system disorders comprised the most frequent (> 5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions (5.4)] .

Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.

8.5Geriatric Use A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related). Adverse Event Zolpidem Placebo Dizziness 3% 0%…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use 137 words ▾

Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.

🧓 Geriatric Use 190 words ▾

Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.

The dose of zolpidem tartrate tablets in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions (5.1) ].

🆘 Overdosage 209 words ▾

10 OVERDOSAGE

10.1Signs and Symptoms In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.

10.2Recommended Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions).

As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs.

The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ 1 receptor preferentially with a high affinity ratio of the α 1 /α 5 subunits.

This selective binding of zolpidem on the BZ 1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses.

12.3Pharmacokinetics The pharmacokinetic profile of zolpidem tartrate tablets are characterized by rapid absorption from the gastrointestinal tract and a short elimination half-life (T 1/2 ) in healthy subjects. In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg zolpidem tartrate tablets, the mean peak concentrations (C max ) were 59 (range: 29 to 113) and 121 (range: 58 to 272) ng/mL, respectively, occurring at a mean time (T max ) of 1.6 hours for both. The mean zolpidem tartrate tablets elimination half-life was 2.6 (range: 1.4 to 4.5) and 2.5 (range: 1.4 to 3.8) hours, for the 5 and 10 mg tablets, respectively.

Zolpidem tartrate tablets are converted to inactive metabolites that are eliminated primarily by renal excretion. Zolpidem tartrate tablets demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL.

Zolpidem did not accumulate in young adults following nightly dosing with 20 mg zolpidem tartrate tablets for 2 weeks. A food-effect study in 30 healthy male subjects compared the pharmacokinetics of zolpidem tartrate tablets 10 mg when administered while fasting or 20 minutes after a meal. Results demonstrated that with food, mean AUC and C max were decreased by 15% and 25%, respectively, while mean T max was prolonged by 60% (from 1.4 to 2.2 hr).

The half-life remained unchanged. These results suggest that, for faster sleep onset, zolpidem tartrate tablets should not be administered with or immediately after a meal. Special Populations Elderly: In the elderly, the dose for zolpidem tartrate tablets should be 5 mg [see Warnings and Precautions (5) and Dosage and Administration (2) ].

This recommendation is based on several studies in which the mean C max , T 1/2 , and AUC were significantly increased when compared to results in young adults. In one study of eight elderly subjects (>70 years), the means for C max , T 1/2 , and AUC significantly increased by 50% (255 vs. 384 ng/mL), 32% (2.2 vs.

2.9hr), and 64% (955 vs. 1,562 ng·hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20 mg oral dose. Zolpidem tartrate tablets did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week.

Hepatic Impairment: The pharmacokinetics of zolpidem tartrate tablets in eight patients with chronic hepatic insufficiency were 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 hepatically -compromised patients. 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 normal subjects of 2.2 hr (range: 1.6 to 2.4 hr) [see Dosage and Administration (2.2), Warnings and Precautions (5.7), Use in Specific Populations (8.7)].

Renal Impairment: The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage renal fail…

🧬 Mechanism of Action 132 words ▾

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem tartrate 10 mg tablets, USP are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and '10 MG' debossed on the other side and supplied as: NDC Number Size NDC 68071-1887-1 bottle of 10 NDC 68071-1887-4 bottle of 14 NDC 68071-1887-5 bottle of 15 NDC 68071-1887-2 bottle of 20 NDC 68071-1887-8 bottle of 28 NDC 68071-1887-3 bottle of 30 NDC 68071-1887-6 bottles of 60 NDC 68071-1887-9 bottles of 90 Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59º to 86°F) [see USP Controlled Room Temperature].

📋 Description 108 words ▾

11 DESCRIPTION Zolpidem tartrate is a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N ,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure: Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol.

It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow. Image 1

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with zolpidem. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with zolpidem and with each prescription refill.

Review the zolpidem tartrate tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that zolpidem tartrate tablets should be taken only as prescribed. CNS Depressant Effects and Next-Day Impairment Tell patients that zolpidem 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. 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. Sleep-driving and Other Complex Behaviors Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including "sleep driving" and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms.

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 if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence Tell patients not to increase the dose of zolpidem on their own, and to inform you if they believe the drug "does not work". Administration Instructions Patients should be counseled to take zolpidem right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal.

Advise patients NOT to take zolpidem if they drank alcohol that evening. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. 8063038 Revised February 2017 image

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Z olpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV Read the Medication Guide that comes with zolpidem tartrate tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about zolpidem tartrate tablets? Do not take more zolpidem tartrate tablets than prescribed . Do not take zolpidem tartrate tablets unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again .

Take zolpidem tartrate tablets right before you get in bed, not sooner. Zolpidem tartrate tablets may cause serious side effects, including: After taking zolpidem tartrate tablets, 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.

You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with zolpidem tartrate tablets. Reported activities include: o driving a car ("sleep-driving") o making and eating food o talking on the phone o having sex o sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets. Do not take zolpidem tartrate tablets if you: drank alcohol that evening or before bed took another medicine to help you sleep.

What are zolpidem tartrate tablets? Zolpidem tartrate tablets are sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

It is not known if zolpidem tartrate tablets are safe and effective in children under the age of 18 years. Zolpidem tartrate is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate tablets in a safe place to prevent misuse and abuse.

Selling or giving away zolpidem tartrate tablets may harm others, and is against the law. Tell your healthcare provider if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs. Who should not take zolpidem tartrate tablets?

Do not take zolpidem tartrate tablets if you are allergic to zolpidem or any other ingredients in zolpidem tartrate tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets. Do not take zolpidem tartrate tablets if you have had an allergic reaction to drugs containing zolpidem, such as zolpidem tartrate CR tablets, Edluar, Zolpimist, or Intermezzo.

Symptoms of a serious allergic reaction to zolpidem can include: swelling of your face, lips, and throat that may cause difficulty breathing or swallowing What should I tell my healthcare provider before taking zolpidem tartrate tablets? Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, tell your healthcare provider about all of your health conditions, including if you: have a history of depression, mental illness, or suicidal thoughts have a history of drug or alcohol abuse or addiction have kidney or liver disease have a lung disease or breathing problems are pregnant, planning to become pregnant.

It is not known if zolpidem tartrate tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. Zolpidem tartrate tablets can pass into your breast milk. It is not known if zolpidem tartrate tablets will harm your baby.

Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate tablets. Tell your healthcare provider about all of the medicines you take , including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious si…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

sedative: A substance with a calming effect that can also cause drowsiness.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

controlled substance: A medicine regulated by law because it can be misused or lead to dependence, with special rules for prescribing and storage.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

drug metabolism: The body's chemical process, mainly in the liver, of changing a drug so it can be used or removed.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

misuse: Using a medicine differently from how it was prescribed or directed, whether on purpose or by mistake.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

pharmacokinetic interaction: When one medicine changes how the body absorbs, spreads, breaks down, or removes another, altering its level in the blood.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 68071-1876-00 · NuCare 68071-1890-06 · NuCare →

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.

ZOLPIDEM TARTRATE 10 mg Tablet, 30-count

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

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