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Zolpidem Tartrate 12.5 mg Tablet, Film Coated, Extended Release, 30-count — NDC 71610-0254-30 package photo

Zolpidem Tartrate 12.5 mg Tablet, Film Coated, Extended Release, 30-count

by Aphena Pharma Solutions - Tennessee, LLC · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30)
NDC 71610-0254-30
🏷️ FDA NDC (as labeled) 71610-254-30 billing pads the product segment with a zero
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

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

🆔 Identity & classification

FDA NDC (as labeled) 71610-254-30
Product NDC 71610-254
11-digit billing NDC 71610025430
NCPDP billing unit EA — each (per item)
RxCUI 854880
UNII WY6W63843K
Application # ANDA204170
SPL Set ID ebd6c66b-b230-48d7-b38f-d610b6cb2b6c
Established class (EPC) gamma-Aminobutyric Acid-ergic Agonist
Mechanism of action GABA A Agonists
Physiologic effect Central Nervous System Depression
Chemical class Pyridines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-05-15
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance ZOLPIDEM TARTRATE
GPI-14 60204080100420
GPI class Zolpidem Tartrate ER
GCN Seq No 059697
GCN 25457
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 TART ER 12.5 MG TAB
FDB brand name Zolpidem Tartrate Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71610-254-30 — 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 → 71610-0254-30. 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA204170 (ANDA)
Labeler code71610
First marketedMay 2017
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio795 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.

🩺 Clinical

Label name ZOLPIDEM TART ER 12.5 MG TAB Ingredient Zolpidem Tartrate
📖 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 →
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 / White
ShapeRound
Imprint308
Size8 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 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 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.

15 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.

💲 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 · Q2 2026 $0.2773 $8.32 / 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zolpidem Tartrate 12.5 mg 51991-0982-01 Breckenridge 100 tablets $0.106 AB Availability likely —
Zolpidem Tartrate 12.5 mg 68180-0780-01 Lupin 100 tablets $0.106 AB Discontinued —
Zolpidem tartrate 12.5 mg 00781-5316-01 Sandoz 100 tablets $0.140 AB FDA listed —
Ambien CR 12.5 mg 00024-5521-31 Sanofi-Aventis 100 tablets $22.592 AB Discontinued —
Ambien CR 12.5 mg 00713-5521-01 Cosette 100 tablets $22.592 AB Availability likely —
Zolpidem Tartrate 12.5 mg 47335-0308-13 Sun 500 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 50090-7557-02 A-S 100 tablets — AB Discontinued —
zolpidem tartrate 12.5 mg 51407-0762-01 Golden 100 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 60760-0819-30 St. 30 tablets — AB FDA listed —
Zolpidem tartrate 12.5 mg 63187-0114-30 Proficient 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 63187-0862-15 Proficient 15 tablets — AB FDA listed —
Zolpidem tartrate 12.5 mg 63629-4597-01 Bryant 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 68071-2354-09 NuCare 90 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 68788-7422-02 Preferred 28 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 68788-8376-02 Preferred 28 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 71205-0286-30 Proficient 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 71335-1180-01 Bryant 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 71335-1468-01 Bryant 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mgthis 71610-0254-30 Aphena 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 71610-0730-30 Aphena 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 72162-2441-01 Bryant 100 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 72189-0230-30 DIRECT 30 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 76420-0319-01 Asclemed 100 tablets — AB FDA listed —
Zolpidem Tartrate 12.5 mg 76420-0496-01 Asclemed 100 tablets — 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

🏛️
2017
On the market since
May 2017
📍
2026
Currently FDA-listed
9 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
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.

🔬 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

134,360 reports
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
2019 2021 2023 2026 9,427 0
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 NDCDescription Marketing startStatus
71610-0254-30 You're viewing this 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30) 2019-03-22 Active

🧭 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 71610-254-30, 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: 71610-0254-30, written without dashes as 71610025430. 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 71610-0254-30, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0254) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC 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 105 words ▾

1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies ( 14 )] . Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

(1)

⏱️ 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 12.5 mg daily ( 2.1 ) Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 mg or 12.5 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.1 ) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate extended-release tablets ( 2.3 ) Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4 ) The effect of zolpidem tartrate extended-release 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 6.25 mg for women and either 6.25 or 12.5 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 6.25 mg dose is not effective, the dose can be increased to 12.5 mg.

In some patients, the higher morning blood levels following use of the 12.5 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 extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime. Zolpidem tartrate extended-release 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 in these patients is 6.25 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 in these patients is 6.25 mg once daily immediately before bedtime. Avoid zolpidem 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 extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.1 )] .

2.4Administration Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

💊 Dosage Forms and Strengths 102 words ▾

3 DOSAGE FORMS AND STRENGTHS Zolpidem tartrate extended-release tablets, USP are available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored. Zolpidem tartrate extended-release tablets, USP 6.25 mg are round biconvex bi-layer coated tablets with pink layer and white layer and imprinted with “307” on one side and other side plain.

Zolpidem tartrate extended-release tablets, USP 12.5 mg are round biconvex bi-layer coated tablets with yellow layer and white layer and imprinted with “308” on one side and other side plain. Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored.

(3)

⛔ Contraindications 35 words ▾

4 CONTRAINDICATIONS Zolpidem tartrate extended-release tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3) ]. 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. Caution patients against driving and other activities requiring complete mental alertness the morning after use. ( 5.1 ) Need to evaluate for comorbid diagnoses: Re-evaluate 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 use in patients with severe hepatic impairment. ( 5.7 ) Withdrawal effects: Symptoms may occur with rapid dose reduction or discontinuation ( 5.8 , 9.3 )

5.1CNS-Depressant Effects and Next-Day Impairment Zolpidem tartrate extended-release tablets are central nervous system (CNS) depressant and can impair daytime function in some patients even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e. less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of zolpidem tartrate extended-release tablets may develop, patients using zolpidem tartrate extended-release tablets should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.

Additive effects occur with concomitant use of other CNS depressants (e.g. benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of zolpidem tartrate extended-release tablets and concomitant CNS depressants should be considered [see Dosage and Administration ( 2.3 )] . The use of zolpidem tartrate extended-release tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

The risk of next-day psychomotor impairment is increased if zolpidem tartrate extended-release tablet is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or 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 extended-release tablet is taken in these circumstances [see Dosage and Administration ( 2 ) and 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, 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. Because zolpidem tartrate extended-release tablets can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

5.2Need to Evaluate for Comorbid 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 medi…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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) ] Most commonly observed adverse reactions (>10% in either elderly or adult patients) are: headache, next-day somnolence and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Associated with Discontinuation of Treatment In 3-week clinical trials in adults and elderly patients (>65 years), 3.5% (7/201) patients receiving zolpidem tartrate extended-release tablets 6.25 mg or 12.5 mg discontinued treatment due to an adverse reactions as compared to 0.9% (2/216) of patients on placebo. The reaction most commonly associated with discontinuation in patients treated with zolpidem tartrate extended-release tablets was somnolence (1%). In a 6-month study in adult patients (18 to 64 years of age), 8.5% (57/669) of patients receiving zolpidem tartrate extended-release tablets 12.5 mg as compared to 4.6% on placebo (16/349) discontinued treatment due to an adverse reaction.

Reactions most commonly associated with discontinuation of zolpidem tartrate extended-release tablets included anxiety (anxiety, restlessness or agitation) reported in 1.5% (10/669) of patients as compared to 0.3% (1/349) of patients on placebo, and depression (depression, major depression or depressed mood) reported in 1.5% (10/669) of patients as compared to 0.3% (1/349) of patients on placebo. 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 treatment with zolpidem tartrate extended-release tablets in adults and elderly at daily doses of 12.5 mg and 6.25 mg, respectively, each for three weeks, the most commonly observed adverse reactions associated with the use of zolpidem tartrate extended-release tablets were headache, next-day somnolence, and dizziness. In the 6-month trial evaluating zolpidem tartrate extended-release tablets 12.5 mg, the adverse reaction profile was consistent with that reported in short-term trials, except for a higher incidence of anxiety (6.3% for zolpidem tartrate extended-release tablets versus 2.6% for placebo).

Adverse Reactions Observed at an Incidence of ≥1% in Controlled Trials The following tables enumerate treatment-emergent adverse reaction frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate extended-release tablets in placebo-controlled trials. Events reported by investigators were classified utilizing the MedDRA dictionary 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 rel…

🔄 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 (rifampin or St. John’s wort): Combination use may decrease effect ( 7.2 ) Ketoconazole: Combination use may increase effect ( 7.2 )

7.1CNS-Active Drugs Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions (5.1)]. 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 Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem.

Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended [see Clinical Pharmacology (12.3)] . St. John’s wort Use of St.

John’s wort, a CYP3A4 inducer, in combination with zolpidem may decrease blood levels of zolpidem and is not recommended. CYP3A4 Inhibitors Ketoconazole 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: 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 tartrateadministration. ( 8.2 ) Pediatric use: Safety and effectiveness not established.

Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse 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 Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see Data] . Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data] .

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% 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 extended-release tablets during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. Data Human data Published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects.

There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.

Zolpidem has been shown to cross the placenta. Animal data Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the maximum recommended human dose (MRHD) of 12.5 mg/day (10 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 20 and 100 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, 8, and 30 times the MRHD of 12.5 mg/day (10 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 30 times the MRHD based on mg/m 2 body surface area.

Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the MRHD of 12.5 mg/day (10 mg zolpidem base) based on a mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 20 and 100 times, respectively, the MRHD based on mg/m 2 body surface area.

8.2 Lactation Risk Summary Limited data from published literature report…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see Data] . Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data] .

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% 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 extended-release tablets during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. Data Human data Published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects.

There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.

Zolpidem has been shown to cross the placenta. Animal data Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the maximum recommended human dose (MRHD) of 12.5 mg/day (10 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 20 and 100 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, 8, and 30 times the MRHD of 12.5 mg/day (10 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 30 times the MRHD based on mg/m 2 body surface area.

Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the MRHD of 12.5 mg/day (10 mg zolpidem base) based on a mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 20 and 100 times, respectively, the MRHD based on mg/m 2 body surface area.

🧒 Pediatric Use 164 words ▾

8.4Pediatric Use Zolpidem tartrate extended-release tablets are 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. FDA has not required pediatric studies of zolpidem tartrate extended-release tablets in the pediatric population based on these efficacy and safety findings.

🧓 Geriatric Use 116 words ▾

8.5Geriatric Use A total of 99 elderly (≥65 years of age) received daily doses of 6.25 mg zolpidem tartrate extended-release tablets in a 3-week placebo-controlled study. The adverse reaction profile of zolpidem tartrate extended-release tablets 6.25 mg in this population was similar to that of zolpidem tartrate extended-release tablets 12.5 mg in younger adults (≤64 years of age). Dizziness was reported in 8% of zolpidem tartrate extended-release tablets-treated patients compared with 3% of those treated with placebo.

The dose of zolpidem tartrate extended-release tablets in elderly patients is 6.25 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 is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

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 5HT 2 , adrenergic, histaminergic or muscarinic receptors.

12.3Pharmacokinetics Zolpidem tartrate extended-release tablets exhibit biphasic absorption characteristics, which results in rapid initial absorption from the gastrointestinal tract similar to zolpidem tartrate immediate-release, then provides extended plasma concentrations beyond three hours after administration. A study in 24 healthy male subjects was conducted to compare mean zolpidem plasma concentration-time profiles obtained after single oral administration of zolpidem tartrate extended-release tablets 12.5 mg and of an immediate-release formulation of zolpidem tartrate (10 mg).

The terminal elimination half-life observed with zolpidem tartrate extended-release tablets (12.5 mg) was similar to that obtained with immediate-release zolpidem tartrate (10 mg). The mean plasma concentration-time profiles are shown in Figure 1. In adult and elderly patients treated with zolpidem tartrate extended-release tablets, there was no evidence of accumulation after repeated once-daily dosing for up to two weeks.

Absorption Following administration of zolpidem tartrate extended-release tablets, administered as a single 12.5 mg dose in healthy male adult subjects, the mean peak concentration (C max ) of zolpidem was 134 ng/mL (range: 68.9 to 197 ng/ml) occurring at a median time (T max ) of 1.5 hours. The mean AUC of zolpidem was 740 ng·hr/mL (range: 295 to 1359 ng·hr/mL). A food-effect study in 45 healthy subjects compared the pharmacokinetics of zolpidem tartrate extended-release tablets 12.5 mg when administered while fasting or within 30 minutes after a meal.

Results demonstrated that with food, mean AUC and C max were decreased by 23% and 30%, respectively, while median T max was increased from 2 hours to 4 hours. The half-life was not changed. These results suggest that, for faster sleep onset, zolpidem tartrate extended-release tablets should not be administered with or immediately after a meal.

Distribution Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Metabolism Zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion. Elimination When zolpidem tartrate extended-release tablets were administered as a single 12.5 mg dose in healthy male adult subjects, the mean zolpidem elimination half-life was 2.8 hours (range: 1.62 to 4.05 hr).

Special Populations Elderly In 24 elderly (≥65 years) healthy subjects administered a single 6.25 mg dose of zolpidem tartrate extended-release tablets, the mean peak concentration (C max ) of zolpidem was 70.6 (range: 35 to 161) ng/mL occurring at a median time (T max ) of 2 hours. The mean AUC of zolpidem was 413 ng·hr/mL (range: 124 to 1190 ng·hr/mL) and the mean elimination half-life was 2.9 hours (range: 1.59 to 5.5 hours). Hepatic impairment Zolpidem tartrate extended-release tablets were not studied in patients with hepatic impairment.

The pharmacokinetics of an immediate-release formulation of zolpidem tartrate in eight patients with chronic hepatic insufficiency was compared to results in healthy subjects. Following a single 20 mg oral zolpidem tartr…

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

📦 How Supplied / Storage and Handling 160 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem tartrate extended-release tablets, USP, 6.25 mg are round biconvex bi-layer coated tablets with pink layer and white layer and imprinted with “307” on one side and plain on other side. Zolpidem tartrate extended-release tablets, USP, 6.25 mg are supplied as follows: Bottles of 100’s with Child Resistant Cap ………………..…... NDC 47335-307-88 Bottles of 500’s with Non Child Resistant Cap …………..…...

NDC 47335-307-13 Zolpidem tartrate extended-release tablets, USP, 12.5 mg are round biconvex bi-layer coated tablets with yellow layer and white layer and imprinted with “308” on one side and plain on other side. Zolpidem tartrate extended-release tablets, USP, 12.5 mg are supplied as follows: Bottles of 100’s with Child Resistant Cap ………………..…... NDC 47335-308-88 Bottles of 500’s with Non Child Resistant Cap …………..…...

NDC 47335-308-13 Storage: Store zolpidem tartrate extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [ see USP Controlled Room Temperature ].

📋 Description 200 words ▾

11 DESCRIPTION Zolpidem tartrate extended-release tablets, USP contain zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets, USP are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)­tartrate (2:1).

It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder that is slightly soluble in water, sparingly soluble in alcohol, and propylene glycol. It has a molecular weight of 764.86. Zolpidem tartrate extended-release tablets, USP consist of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content.

The 6.25 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide red, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The 12.5 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide yellow, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80.

The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, and ammonium hydroxide. It meets USP Dissolution Test 2. chemical-structure

💬 Information for Patients ~3 min read ▾

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

Review the zolpidem tartrate extended-release tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that zolpidem tartrate extended-release tablets should be taken only as prescribed. CNS-Depressant Effects and Next-Day Impairment Tell patients that zolpidem tartrate extended-release tablets can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed.

Caution patients against driving and other activities requiring complete mental alertness the day after use. 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.

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 tartrate extended-release tablets if they drank alcohol that evening or before bed. Tolerance, Abuse, and Dependence Tell patients not to increase the dose of zolpidem tartrate extended-release tablets 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 extended-release tablets 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 extended-release tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate extended-release tablets if they drank alcohol that evening. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with zolpidem tartrate extended-release tablets.

Advise patients that use of zolpidem tartrate extended-release tablets late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used zolpidem tartrate extended-release tablets during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations (8.1)]. Lactation Advise breastfeeding mothers using zolpidem tartrate extended-release tablets to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness.

Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after zolpidem tartrate extended-release tablets administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2)] .

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Zolpidem Tartrate (zole-PI-dem TAR-trate) Extended-Release Tablets, USP C-IV Read the Medication Guide that comes with zolpidem tartrate extended-release 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 extended-release tablets? Do not take more zolpidem tartrate extended-release tablets than prescribed. Do not take zolpidem tartrate extended-release 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 extended-release tablets right before you get in bed, not sooner. Zolpidem tartrate extended-release tablets may cause serious side effects that you may not know are happening to you. These side effects include: sleepiness during the day not thinking clearly act strangely, confused, or upset “sleep-walking” or doing other activities when you are asleep like: o eating o talking o having sex o driving a car Call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate extended-release tablets.

You should not drive a car or do things that require clear thinking the day after you take zolpidem tartrate extended-release tablets. Do not take zolpidem tartrate extended-release tablets if you: drank alcohol that evening or before bed. take other medicines that can make you sleepy. Taking zolpidem tartrate extended-release tablets with other drugs can cause side effects.

Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take zolpidem tartrate extended-release tablets with your other medicines. cannot get a full night’s sleep. What are zolpidem tartrate extended-release tablets?

Zolpidem tartrate extended-release tablets are a sedative-hypnotic (sleep) medicine. Zolpidem tartrate extended-release tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include: trouble falling asleep waking up often during the night Zolpidem tartrate extended-release tablets are not recommended for use in children under the age of 18 years.

Zolpidem tartrate extended-release tablets are federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate extended-release 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 extended-release tablets? Do not take zolpidem tartrate extended-release tablets if you are allergic to zolpidem or any other ingredients in zolpidem tartrate extended-release tablets.

See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate extended-release tablets. Do not take zolpidem tartrate extended-release tablets if you have had an allergic reaction to drugs containing zolpidem, such as Ambien*, 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 extended-release tablets?

Zolpidem tartrate extended-release tablets may not be right for you. Before starting zolpidem tartrate extended-release 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 p…

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