Prescription medicine
Zolpidem Brand names: Ambien, Edluar
Zolpidem (Ambien) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.0344 per zolpidem tartrate 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the zolpidem FDA label on DailyMed (effective August 15, 2022, Viatris Specialty LLC); the NDA 19908 record on Drugs@FDA; every zolpidem label on DailyMed.
Highlights of the record
FDA label of August 15, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar 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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior.
Used for
From the label: indications and usageEdluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ].
Forms and strengths
- 1.75 mg
- 3.5 mg
- 5 mg
- 6.25 mg
- 7.5 mg
- 10 mg
- 12.5 mg
Tablet; film-coated tablet; extended-release tablet; coated tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- December 16, 1992 Ambien, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 34 first April 23, 2007; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 43 of which 39 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- August 7, 2032 Zolpimist spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0344 per tablet Zolpidem tartrate 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest January 18, 2024
- FAERS reports
- 134,363 through July 30, 2026
What is zolpidem used for?
From the label: indications and usageEdluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Edluar, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.
Conditions named in the indications of zolpidem's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: gamma-Aminobutyric Acid A Receptor Positive Modulator and gamma-Aminobutyric Acid-ergic Agonist.
Source: FDA drug label (Edluar), Viatris Specialty LLC, effective August 15, 2022 (SPL set a32884d0-85b5-11de-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What does the patient leaflet for zolpidem say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Edluar?Do not take more Edluar than prescribed. • Do not take Edluar unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. • Take Edluar right before you get in bed, not sooner. Edluar may cause serious side effects, including: • Complex sleep behaviors that have caused serious injury and death. After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with Edluar whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include: o driving a car (“sleep-driving”) o making and eating food o talking on the phone o having sex o sleep-walking Stop taking Edluar and call your healthcare provider right away if you find out that you have done any of the above activities after taking Edluar. Do not take Edluar if you: • have ever experienced a complex sleep behavior (such as driving a car, making or eating food, talking on the phone, or having sex) while not being fully awake after taking Edluar • drank alcohol that evening or before bed • took another medicine to help you sleep
From the patient leaflet: How should I store Edluar?Store Edluar at room temperature, between 68°F and 77°F (20° to 25°C). • Protect from light and moisture. Keep Edluar and all medicines out of reach of children.
Source: FDA drug label (Edluar), Viatris Specialty LLC, effective August 15, 2022 (SPL set a32884d0-85b5-11de-8a39-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for zolpidem (Ambien)?
The FDA approved the first generic zolpidem on April 23, 2007. 34 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists zolpidem from 39 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ambien CR tablets; a patent listed only for Zolpimist spray runs to August 7, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2007 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for zolpidem (Ambien)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0344 per Zolpidem tartrate 5 mg tablet, about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zolpidem tartrate 5 mg tablet (generic)
- Edluar 10 mg sl tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Zolpidem tart 1.75 mg tablet sl | Generic | $5.05 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $151.37 | -2% |
| Zolpidem tart 3.5 mg tablet sl | Generic | $5.79 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $173.70 | +6% |
| Zolpidem tart ER 12.5 mg tablet | Generic | $0.109 per tablet | $3.28 | -10% |
| Zolpidem tart ER 6.25 mg tablet | Generic | $0.102 per tablet | $3.05 | -19% |
| Zolpidem tartrate 10 mg tablet | Generic | $0.0396 per tablet | $1.19 | +4% |
| Zolpidem tartrate 5 mg tablet | Generic | $0.0344 per tablet | $1.03 | -0.3% |
| Zolpidem tartrate 7.5 mg capsule | Generic | $7.93 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $238.00 | -0.1% |
| Ambien 10 mg tablet | Brand | $22.61 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $678.41 | +10% |
| Ambien cr 12.5 mg tablet | Brand | $22.57 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $677.18 | +9% |
| Edluar 10 mg sl tablet | Brand | $15.48 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $464.52 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has zolpidem been recalled?
The FDA's Enforcement Report lists 6 recalls naming zolpidem since 2013: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 18, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| April 22, 2015 | Class II | Wockhardt Usa Inc. | CGMP Deviations: Firm did not adequately investigate customer complaints. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree … |
| May 21, 2013 | Class II | American Health Packaging | Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the zolpidem label say about other medicines?
The zolpidem label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name zolpidem. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlorpromazine | drug interactions | 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. |
| Digoxin | drug interactions | Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects. |
| Fluoxetine | drug interactions | Fluoxetine After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. |
| Haloperidol | drug interactions | Haloperidol A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. |
| Imipramine | drug interactions | Imipramine: decreased alertness observed |
| Itraconazole | drug interactions | A single-dose interaction study with zolpidem tartrate 10 mg and itraconazole 200 mg at steady-state levels in male volunteers resulted in a 34% increase in AUC 0-∞ of zolpidem tartrate. |
| Ketoconazole | drug interactions | Ketoconazole: combination use may increase effect |
| Rifampin | drug interactions | Rifampin: combination use may decrease effects |
| Sertraline | drug interactions | Sertraline Concomitant administration of zolpidem and sertraline increases exposure to zolpidem and may increase the pharmacodynamics effect of zolpidem [see Clinical Pharmacology (12.3) ]. |
| Warfarin | drug interactions | Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects. |
Other labels that name zolpidem
Source: FDA drug label (Edluar), Viatris Specialty LLC, effective August 15, 2022 (SPL set a32884d0-85b5-11de-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show for zolpidem?
The FDA Adverse Event Reporting System holds 134,363 reports that list zolpidem among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15,992 are coded as a death and 46,181 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as zolpidem?
11 other medicines are given the same way (oral) and in the same FDA class as zolpidem or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Eszopiclone | Insomnia | 26 labelers | $0.0993 per tablet 1 mg tablet | No current entry |
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Ramelteon | Insomnia | 27 labelers | $0.660 per tablet 8 mg tablet | A presentation being discontinued |
| Zaleplon | Insomnia | 9 labelers | $0.141 per capsule 10 mg capsule | No current entry |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
| Estazolam | Insomnia | 3 labelers | $0.839 per tablet 2 mg tablet | No current entry |
| Suvorexant | Insomnia | none listed | $15.21 per tablet 10 mg tablet | No current entry |
| Daridorexant | Insomnia | none listed | $16.70 per tablet 25 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does zolpidem compare with medicines for the same use?
6 side-by-side pages set zolpidem beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to zolpidem
- 11 medicines for the same use
- Other gamma-aminobutyric acid-ergic agonists
- the pharmacologic class, with prices and generics
- Zolpidem side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other