Home › NDC Lookup › Ingredients › Zolpidem Tartrate › 63187-0114-30
Zolpidem tartrate 12.5 mg Tablet, Extended Release, 30-count — NDC 63187-0114-30 package photo

Zolpidem tartrate 12.5 mg Tablet, Extended Release, 30-count

by Proficient Rx LP · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-114-30)
NDC 63187-0114-30
🏷️ FDA NDC (as labeled) 63187-114-30 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) 63187-114-30
Product NDC 63187-114
11-digit billing NDC 63187011430
NCPDP billing unit EA — each (per item)
RxCUI 854880
UNII WY6W63843K
Application # ANDA090107
SPL Set ID 25e71199-c55d-4cc6-8388-b309d654d2b0
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 2011-10-31
Route ORAL
Dosage form TABLET, 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 63187-114-30 — 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 → 63187-0114-30. 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

LabelerProficient Rx LP
Application holderSANDOZ INC
FDA applicationANDA090107 (ANDA)
Labeler code63187
First marketedOct 2011
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio1,723 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 Pink
ShapeRound
ImprintSZ;229
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 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.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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 mgthis 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 mg 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

🏛️
2011
On the market since
Oct 2011
📍
2026
Currently FDA-listed
15 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
63187-0114-30 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-114-30) 2019-01-01 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 63187-114-30, 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: 63187-0114-30, written without dashes as 63187011430. 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 63187-0114-30, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0114) 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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 104 words ▾

1INDICATIONS AND USAGE Zolpidem tartrate extended-release tablet, USP is 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 extended-release tablet, USP a gamma-aminobutyric acid (GABA) A agonist, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2DOSAGE AND ADMINISTRATION • Use the lowest dose effective for the patient ( 2.1 ) • Recommended initial dose is 6.25 mg for women, and 6.25 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 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, USP ( 2.3 ) • Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4 ) • The effect of zolpidem tartrate extended-release tablets, USP 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 to 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 tablet, USP should not exceed 12.5 mg once daily immediately before bedtime. 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. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.1) ; USE IN SPECIFIC POPULATIONS (8.5) ].

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 91 words ▾

3 DOSAGE FORMS AND STRENGTHS Zolpidem tartrate extended-release tablets, USP containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored. Zolpidem tartrate extended-release tablets, 6.25 mg are dark pink, round, biconvex film-coated tablets debossed with SZ on one side and 228 on the other side.

Zolpidem tartrate extended-release tablets, 12.5 mg tablets are light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. Tablets: 6.25 mg and 12.5 mg extended-release tablets. 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 ▾

5WARNINGS 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 co-morbid diagnoses: Revaluate 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 ) • Withdrawal effects: Symptoms may occur with rapid dose reduction or discontinuation ( 5.7 , 9.3 )

5.1CNS Depressant Effects and Next-Day Impairment Zolpidem tartrate extended-release are a 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 may develop, patients using zolpidem tartrate extended-release 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 tablet are and concomitant CNS depressants should be considered [see DOSAGE AND ADMINISTRATION (2.3) ]. The use of zolpidem tartrate extended-release 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 is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem [see DOSAGE AND ADMINISTRATION (2) and CLINICAL STUDIES (14.2) ].

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 larynx, airway obstruction may occur and be fatal. Patients who develop angioedema…

🤒 Adverse Reactions ~3 min read ▾

6ADVERSE 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 (5.7) ] 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or http://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 6.25 or 12.5 mg discontinued treatment due to an adverse reaction 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 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 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 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 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 were headache, next-day somnolence, and dizziness. In the 6-month trial evaluating zolpidem tartrate extended-release 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 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 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 relative contribution of drug and nondrug factors to the incidence of side effects in the…

🔄 Drug Interactions ~2 min read ▾

7DRUG 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 ) • Rifampin: Combination use may decrease effect ( 7.2 ) • 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 [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 inhibit CYP3A may increase exposure to zolpidem. The effect of drugs on other P450 enzymes on the exposure to zolpidem is not known. 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. Ketoconazole Ketoconazole, a potent CYP3A4 inhibitor, increased the pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.

👥 Use in Specific Populations ~3 min read ▾

8USE 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 extended-release 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 tartrate extended-release 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 extended-release maximum recommended human dose (MRHD) of 12.5 mg/day (approximately 10 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 4 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. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 8 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 4 times the MRHD on a mg/m 2 basis.

8.2Labor and Delivery Zolpidem tartrate extended-release tablet has 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 tartrate extended-release tablet is administered to a nursing woman.

8.4Pediatric Use Zolpidem tartrate extended-release 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 to 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.

8.5Geriatric Use A total of 99 elderly (≥ 65 years of age) received daily doses of 6.25 mg zolpidem tartrate extended-release in a 3-week placebo-controlled study. The adverse reaction profile of zolpidem tartrate extended-…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release 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 tartrate extended-release 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 extended-release maximum recommended human dose (MRHD) of 12.5 mg/day (approximately 10 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 4 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. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 8 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 4 times the MRHD on a mg/m 2 basis.

🧒 Pediatric Use 163 words ▾

8.4Pediatric Use Zolpidem tartrate extended-release 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 to 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 112 words ▾

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

The dose of zolpidem tartrate extended-release 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 208 words ▾

10OVERDOSAGE

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 ▾

12CLINICAL 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 Zolpidem tartrate extended-release exhibits 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 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 (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 . Figure 1: Mean plasma concentration-time profiles for zolpidem tartrate extended-release (12.5 mg) and immediate-release zolpidem tartrate (10 mg) Figure 1: Mean plasma concentration-time profiles for zolpidem tartrate extended-release (12.5 mg) and immediate-release zolpidem tartrate (10 mg) In adult and elderly patients treated with zolpidem tartrate extended-release, there was no evidence of accumulation after repeated once-daily dosing for up to two weeks.

Absorption: Following administration of zolpidem tartrate extended-release, 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 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 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 was 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, 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 5.50 hours). Hepatic Impairment: Zolpidem tartrate extended-release was not studied in patients with…

🧬 Mechanism of Action 132 words ▾

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.

📦 How Supplied / Storage and Handling 75 words ▾

16HOW SUPPLIED/STORAGE AND HANDLING Zolpidem tartrate extended-release tablets, USP are available as follows: 12.5 mg, light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. NDC 63187-114-30, bottles of 30 tablets The tablets are to be swallowed whole and should not be crushed, chewed, or divided. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant, child-resistant container.

📦 Storage and Handling 21 words ▾

Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container.

📋 Description 126 words ▾

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

It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Zolpidem tartrate extended-release tablet, USP is available for oral administration as a film-coated tablet containing 6.25 mg and 12.5 mg of zolpidem tartrate.

Inactive ingredients consist of colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, red ferric oxide, talc, and titanium dioxide. USP Dissolution test 4 used. Chemical Structure

💬 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 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. 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.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Zolpidem Tartrate Extended-Release Tablets, USPC-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: • eating • talking • having sex • 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 is zolpidem tartrate extended-release tablets? Zolpidem tartrate extended-release tablets is 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 It is not known if zolpidem tartrate extended-release tablets are safe and effective in children under the age of 18 years. Zolpidem tartrate extended-release tablets are a 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 zolpidem tartrate 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 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 dise…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63187-0112-15 · Proficient 63187-0118-30 · Proficient →
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.