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Ambien CR zolpidem tartrate 12.5 mg Tablet, Coated, 100-count

by Sanofi-Aventis U.S. LLC · 100 TABLET, COATED in 1 BOTTLE (0024-5521-31)
NDC 00024-5521-31
🏷️ FDA NDC (as labeled) 0024-5521-31 billing pads the labeler segment with a zero
Rx only Brand Discontinued CIV ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0024-5521-31
Product NDC 0024-5521
11-digit billing NDC 00024552131
NCPDP billing unit EA — each (per item)
RxCUI 854880, 854882, 854894, 854896
UNII WY6W63843K
Application # NDA021774
SPL Set ID 404c858c-89ac-4c9d-8a96-8702a28e6e76
Established class (EPC) gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of action GABA A Receptor Positive Modulators
Physiologic effect Central Nervous System Depression
DEA schedule CIV
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2005-09-19
Marketing end 2026-07-31
Route ORAL
Dosage form TABLET, COATED
Substance ZOLPIDEM TARTRATE
GPI-14 60204080100420
GPI class Ambien CR
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 AMBIEN CR 12.5 MG TABLET
FDB brand name Ambien Cr
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 0024-5521-31 — a 4-4-2 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 labeler segment → 00024-5521-31. 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

LabelerSanofi-Aventis U.S. LLC
Application holderCOSETTE PHARMACEUTICALS INC
FDA applicationNDA021774 (NDA)
Labeler code00024
First marketedSep 2005
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio84 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 AMBIEN CR 12.5 MG TABLET 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eaPer package
Retail pharmacies payNADAC · weekly $22.592 $2,259.20 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $20.79 $2,079.27 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Apr 2021 Jan 2023 Jan 2026 Aug 2026 $22.592 $18.632
▲ Up 21% over the last 7 months.
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 save 100%
Zolpidem Tartrate 12.5 mg 68180-0780-01 Lupin 100 tablets $0.106 AB Discontinued save 100%
Zolpidem tartrate 12.5 mg 00781-5316-01 Sandoz 100 tablets $0.140 AB FDA listed save 99%
Ambien CR 12.5 mgthis 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 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 the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2005
On the market since
Sep 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00024-5521-31, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
223
Units reimbursed last 4 qtrs
6.5K
Gross reimbursed last 4 qtrs
$134.5K
Avg / prescription
$603.18
Avg / unit
$20.7927
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$20.7927
gross reimbursed
vs
NADAC / ea
$22.5920
acquisition cost
=
Spread
−$1.7993
-8% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
60% FFS 40% MCO
Fee-for-service · 134 Rx Managed care · 89 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,280 units · 22.3 per 100k residents MN Wisconsin: no data reported WI Michigan: 835 units · 8.3 per 100k residents MI New York: 2,010 units · 10.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 480 units · 5.5 per 100k residents VA Maryland: no data reported MD Connecticut: 966 units · 26.7 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 898 units · 2.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.926.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 26.7 /100k
2 Minnesota 22.3 /100k
3 New York 10.3 /100k
4 Michigan 8.3 /100k
5 Virginia 5.5 /100k
6 Texas 2.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Ambien Cr — the program that covers self-administered drugs. 2 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 Ambien Cr. 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
$1.08M
Claims incl. refills
1.3K
Beneficiaries
643
Spend / beneficiary
$1,676.87
Spend / claim
$812.53
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00024-5521-31 You're viewing this 100 TABLET, COATED in 1 BOTTLE (0024-5521-31) 2005-09-19 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0024-5521-31, 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: 00024-5521-31, written without dashes as 00024552131. 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 00024-5521-31, the first segment (00024) is the labeler code FDA assigned to Sanofi-Aventis U.S. LLC; the middle segment (5521) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Sanofi-Aventis U.S. 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.
🚨 Boxed Warning 🎯 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
🚨 Boxed Warning 120 words ▾

WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ].

WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death.

Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )

🎯 Indications and Usage 109 words ▾

1 INDICATIONS AND USAGE AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term 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) ] .

AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term 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 ) Treatment should be as short as possible ( 2.1 ) Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening ( 2.1 ) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with AMBIEN CR ( 2.3 ) Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4 ) The effect of AMBIEN CR 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 (5.2) ] . The total dose of AMBIEN CR should not exceed 12.5 mg once daily immediately before bedtime. AMBIEN CR 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. Treatment with AMBIEN CR should be as short as possible. Extended treatment should not take place without re-evaluation of the patient's status, since the risk of abuse and dependence increases with duration of treatment [see Drug Abuse and Dependence (9.3) ] .

2.2Special Populations Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.2) , 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 AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime. Avoid AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.8) , Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] .

2.3Use with CNS Depressants Dosage adjustment may be necessary when AMBIEN CR is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.2 , 5.7) ] .

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

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS AMBIEN CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored. AMBIEN CR 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side. AMBIEN CR 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side. Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored. ( 3 )

⛔ Contraindications 62 words ▾

4 CONTRAINDICATIONS AMBIEN CR is contraindicated in patients who have experienced complex sleep behaviors after taking AMBIEN CR [see Warnings and Precautions (5.1) ]. with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4) ]. Patients who have experienced complex sleep behaviors after taking AMBIEN CR ( 4 ) Known hypersensitivity to zolpidem ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CNS-Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring complete mental alertness the morning after use.

Instruct patients on correct use. ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported.

Do not rechallenge if such reactions occur. ( 5.4 ) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes.

( 5.5 ) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose. ( 5.6 ) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function.

( 5.7 ) Hepatic Impairment: Avoid AMBIEN CR use in patients with severe hepatic impairment. ( 5.8 ) Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation. ( 5.9 , 9.3 )

5.1Complex Sleep Behaviors Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of AMBIEN CR. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome.

Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with AMBIEN CR alone at recommended doses, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions (7.1) ] .

Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior [see Contraindications (4) ] .

5.2CNS-Depressant Effects and Next-Day Impairment AMBIEN CR is a 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 AMBIEN CR may develop, patients using AMBIEN CR 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 [see Drug Interactions (7.1) ] . Downward dose adjustment of AMBIEN CR and concomitant CNS depressants should be considered [see Dosage and Administration (2.3) ] . The use of AMBIEN CR 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 AMBIEN CR 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 coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if AMBIEN CR is taken in these circumstances [see Dosage and Administration (2) , 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, prolo…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions (5.1) ] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4) ] Abnormal Thinking and Behavior Changes [see Warnings and Precautions (5.5) ] Withdrawal Effects [see Warnings and Precautions (5.9) ] Most commonly observed adverse reactions (>10% in either elderly or adult patients) are: headache, next-day somnolence and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S.

LLC at 1-800-633-1610 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 AMBIEN CR 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 AMBIEN CR was somnolence (1%). In a 6-month study in adult patients (18–64 years of age), 8.5% (57/669) of patients receiving AMBIEN CR 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 AMBIEN CR 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 AMBIEN CR 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 AMBIEN CR were headache, next-day somnolence, and dizziness. In the 6-month trial evaluating AMBIEN CR 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 AMBIEN CR versus 2.6% for placebo).

Adverse Reactions Observed at an Incidence of ≥1% in Controlled Trials The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received AMBIEN CR 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 population studied. The following tables were derived from results of two placebo-controlled efficacy trials involving AMBIEN CR.

These trials involved patients with primary insomnia who were treate…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.2 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 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 CNS Depressants 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 , 5.2) ]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.

Alcohol An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1 , 5.2) ] . Opioids The concomitant use of AMBIEN CR with opioids may increase the risk of respiratory depression. Limit dosage and duration of concomitant use of AMBIEN and opioids [see Dosage and Administration (2.3) , Warnings and Precautions (5.7) ] .

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) ] . 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) ] . 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) ] .

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 AMBIEN CR administration. ( 8.2 ) Pediatric use: Safety and effectiveness not established.

Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. ( 5.5 , 8.4 )

8.1Pregnancy Risk Summary Neonates born to mothers using zolpidem 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%–4% and 15%–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 AMBIEN CR 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.

8.2Lactation Risk Summary Limited data from published literature report the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk [see Clinical Considerations ]. There is no information on the effects of zolpidem on milk production. The developmenta…

🤰 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%–4% and 15%–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 AMBIEN CR 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 158 words ▾

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

Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs 1.5%), headache (12.5% vs 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions (5.5) ] . Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. FDA has not required pediatric studies of AMBIEN CR in the pediatric population based on these efficacy and safety findings.

🧓 Geriatric Use 105 words ▾

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

The dose of AMBIEN CR 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 (5.2) ] .

🆘 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 AMBIEN CR 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 AMBIEN CR 12.5 mg and of an immediate-release formulation of zolpidem tartrate (10 mg).

The terminal elimination half-life observed with AMBIEN CR (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 AMBIEN CR (12.5 mg) and Immediate-Release Zolpidem Tartrate (10 mg) In adult and elderly patients treated with AMBIEN CR, there was no evidence of accumulation after repeated once-daily dosing for up to two weeks.

Figure 1 Absorption Following administration of AMBIEN CR, 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 AMBIEN CR 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, AMBIEN CR 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 AMBIEN CR 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 AMBIEN CR, the mean peak concentration (C max ) of zolpidem was 70.6 (range: 35.0 to 161) ng/mL occurring at a median time (T max ) of 2.0 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 AMBIEN CR was 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 tartrate dose, mean C max and AUC were found to be two times (250 vs 499 ng/mL) and five times (788 vs 4,203 ng∙hr/mL) higher, respectively, in hepatically compromised patients. T max did not change.…

🧬 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 91 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AMBIEN CR 6.25 mg extended-release tablets are composed of two layers Layers are covered by the coating and are indistinguishable. and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0024-5501-31 bottle of 100 AMBIEN CR 12.5 mg extended-release tablets are composed of two layers and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0024-5521-31 bottle of 100 Store between 15°C–25°C (59°F–77°F).

Limited excursions permissible up to 30°C (86°F).

📦 Storage and Handling 11 words ▾

Store between 15°C–25°C (59°F–77°F). Limited excursions permissible up to 30°C (86°F).

📋 Description 177 words ▾

11 DESCRIPTION AMBIEN CR contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN CR (zolpidem tartrate) extended-release tablets is 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 sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. AMBIEN CR consists 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 AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.

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 AMBIEN CR. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN CR and with each prescription refill.

Review the AMBIEN CR Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN CR should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that AMBIEN CR may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake.

Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue AMBIEN CR and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] . CNS-Depressant Effects and Next-Day Impairment Tell patients that AMBIEN CR 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 [see Warnings and Precautions (5.2) ] .

Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions (5.4) ] . Suicide Tell patients to immediately report any suicidal thoughts.

Alcohol and other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use AMBIEN CR if they drank alcohol that evening or before bed. Concomitant Use with Opioids Inform patients and caregivers that potentially serious additive effects may occur if AMBIEN CR is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [Warnings and Precautions (5.2, 5.7), Drug Interactions (7.1)] .

Tolerance, Abuse, and Dependence Tell patients not to increase the dose of AMBIEN CR on their own, and to inform you if they believe the drug "does not work." Administration Instructions Patients should be counseled to take AMBIEN CR 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. AMBIEN CR tablets should not be taken with or immediately after a meal. Advise patients NOT to take AMBIEN CR 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 AMBIEN CR. Advise patients that use of AMBIEN CR late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used AMBIEN CR 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 AMBIEN CR 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 AMBIEN CR administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2) ]…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 2/2022 MEDICATION GUIDE AMBIEN CR ® ( ām'bē-ən see ahr) (zolpidem tartrate) extended-release tablets, for oral use, C-IV What is the most important information I should know about AMBIEN CR?

AMBIEN CR may cause serious side effects, including: Complex sleep behaviors. After taking AMBIEN CR, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.

These activities may happen with AMBIEN CR whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking AMBIEN CR have reported: sleep-walking sleep-driving making and eating food talking on the phone having sex Stop taking ABMIEN CR and tell your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN CR.

What is AMBIEN CR? AMBIEN CR is a prescription sleep medicine used for the treatment of adults who have trouble falling asleep or staying asleep (insomnia). It is not known if AMBIEN CR is safe and effective in children under the age of 18 years.

AMBIEN CR is not recommended for use in children under the age of 18 years. AMBIEN CR is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep AMBIEN CR in a safe place to protect it from theft.

Never give your AMBIEN CR to anyone else because it can cause death or harm them. Selling or giving away this medicine is against the law. Do not take AMBIEN CR if you: have had complex sleep behaviors that happened after taking AMBIEN CR in the past.

See " What is the most important information I should know about AMBIEN CR? are allergic to zolpidem or any of the ingredients in AMBIEN CR. See the end of this Medication Guide for a complete list of ingredients in AMBIEN CR. Before taking AMBIEN CR, tell your healthcare provider about all of your medical conditions, including if you: have a history of depression, mental illness, or suicidal thoughts or actions have a history of drug or alcohol abuse or addiction have kidney or liver disease have a lung disease or breathing problems have sleep apnea have myasthenia gravis are pregnant or plan to become pregnant.

Taking AMBIEN CR in the third trimester of pregnancy may harm your unborn baby. Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with AMBIEN CR. Babies born to mothers who take AMBIEN CR during the third trimester of pregnancy may have symptoms of breathing problems and sedation (such as sleepiness or low muscle tone). are breastfeeding or plan to breastfeed.

AMBIEN CR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take AMBIEN CR. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

AMBIEN CR and other medicines can interact with each other causing serious side effects. AMBIEN CR may affect the way other medicines work, and other medicines may affect how AMBIEN CR works. Especially tell your healthcare provider if you: take benzodiazepines take opioids as it may increase the risk of breathing problems (respiratory depression). take tricyclic antidepressants take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines) drink alcohol You can ask your pharmacist for a list of medicines that interact with AMBIEN CR.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take AMBIEN CR?

Take AMBIEN CR exactly as prescribed. Do not change your dose on your own. Tell your healthcare provider if you think AMBIEN CR is not working for you.

AMBI…

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