Quick answers
- What is Zolpidem tartrate used for?
- The FDA-approved label (Ambien, Sanofi-Aventis U.S. LLC, April 15, 2025) says: “AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies […]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Zolpidem tartrate have a boxed warning?
- Yes. The FDA label for Ambien has a boxed warning (“WARNING: COMPLEX SLEEP BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Zolpidem tartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Zolpidem tartrate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 18, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Zolpidem tartrate?
- 37 companies list prescription products of Zolpidem tartrate in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and Proficient Rx LP.
What Zolpidem tartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies […]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. …
— FDA label: Ambien, Sanofi-Aventis U.S. LLC, effective April 15, 2025. Read the full label on DailyMed →
The FDA has 112 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: COMPLEX SLEEP BEHAVIORS
. Read it on the full label →
98 of 112 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| zolpidem tartrate 1.75 mg tablet | Generic | $4.92 per tablet |
| zolpidem tartrate 10 mg tablet | Generic | $0.0389 per tablet |
| zolpidem tartrate 10 mg tablet | Brand: Edluar | $15.48 per tablet |
| zolpidem tartrate 10 mg tablet, coated | Generic | $0.0389 per tablet |
| zolpidem tartrate 10 mg tablet, film coated | Generic | $0.0389 per tablet |
| zolpidem tartrate 10 mg tablet, film coated | Brand: Ambien | $22.61 per tablet |
| zolpidem tartrate 12.5 mg tablet, coated | Brand: Ambien CR | $22.57 per tablet |
| zolpidem tartrate 12.5 mg tablet, extended release | Generic | $0.1179 per tablet |
| zolpidem tartrate 12.5 mg tablet, film coated, extended release | Generic | $0.1179 per tablet |
| zolpidem tartrate 3.5 mg tablet | Generic | $5.80 per tablet |
| zolpidem tartrate 5 mg tablet | Generic | $0.0346 per tablet |
| zolpidem tartrate 5 mg tablet, coated | Generic | $0.0346 per tablet |
| zolpidem tartrate 5 mg tablet, film coated | Generic | $0.0346 per tablet |
| zolpidem tartrate 6.25 mg tablet, extended release | Generic | $0.1023 per tablet |
| zolpidem tartrate 6.25 mg tablet, film coated, extended release | Generic | $0.1023 per tablet |
| zolpidem tartrate 7.5 mg capsule | Generic | $7.99 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack19 products
- Aphena Pharma Solutions - Tennessee, LLC14 products
- Proficient Rx LP10 products
- A-S Medication Solutions9 products
- NuCare Pharmaceuticals, Inc.8 products
- Asclemed USA, Inc.8 products
- Preferred Pharmaceuticals Inc.6 products
- Advanced Rx of Tennessee, LLC6 products
- Sandoz Inc4 products
- Lupin Pharmaceuticals, Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Cosette Pharmaceuticals, Inc.4 products
- Advanced Rx Pharmacy of Tennessee, LLC4 products
- St. Mary's Medical Park Pharmacy4 products
- Remedyrepack Inc.3 products
- Torrent Pharmaceuticals Limited3 products
- The ACME Laboratories Ltd.2 products
- Chartwell RX, LLC2 products
- ACI Healthcare USA, Inc.2 products
- NorthStar Rx LLC2 products
- Viatris Specialty LLC2 products
- Northwind Health Company, LLC2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Breckenridge Pharmaceutical, Inc.2 products
- Aurobindo Pharma Limited2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Direct_Rx2 products
- Par Health USA, LLC2 products
- Cardinal Health 107, LLC1 product
- Lake Erie Medical DBA Quality Care Products LLC1 product
- Major Pharmaceuticals1 product
- Umedica Laboratories USA Inc.1 product
- DirectRx1 product
- Sanofi-Aventis U.S. LLC1 product
- American Health Packaging1 product
- Almatica Pharma LLC1 product
- Calvin Scott & Co., Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019908 AMBIEN | Cosette | December 16, 1992 | 31, latest February 23, 2022 2022: Labeling · 2022: Labeling · 2022: Labeling |
| NDA021774 AMBIEN CR | Cosette | September 2, 2005 | 18, latest February 23, 2022 2022: Labeling · 2022: Labeling · 2022: Labeling |
| NDA021997 EDLUAR | Viatris | March 13, 2009 | 7, latest August 18, 2019 2019: Labeling · 2019: Labeling · 2018: Labeling |
| NDA215721 ZOLPIDEM TARTRATE | Almatica | May 9, 2023 | — |
Generic approvals (13)
- ANDA076410Teva · April 23, 2007
- ANDA077214Pharmazone · April 23, 2007
- ANDA077322Sandoz · April 23, 2007
- ANDA078413Aurobindo Pharma · May 4, 2007
- ANDA077903Torrent Pharms · August 17, 2007
- ANDA090107Sandoz · July 1, 2011
- ANDA077388Chartwell Molecular · July 30, 2012
- ANDA078970Lupin · September 11, 2013
- ANDA204299Novel Labs Inc · June 3, 2015
- ANDA204170Sun Pharm · January 24, 2017
- ANDA204229Ph Health · September 11, 2017
- ANDA213592Breckenridge · June 4, 2020
- ANDA220717Umedica Labs Pvt · May 12, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 18, 2024 · Class II · Completed · D-0271-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, S — SUN PHARMACEUTICAL INDUSTRIES INC
-
January 18, 2024 · Class II · Completed · D-0272-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Su — SUN PHARMACEUTICAL INDUSTRIES INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ambien, Sanofi-Aventis U.S. LLC, effective April 15, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →