Prescription medicine
Estazolam First approved as Prosom
Estazolam (Prosom) is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.839 per estazolam 2 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the estazolam FDA label on DailyMed (effective November 11, 2022, Novitium Pharma LLC); the NDA 19080 record on Drugs@FDA; every estazolam label on DailyMed.
Highlights of the record
FDA label of November 11, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION.
and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS ). Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including Estazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Estazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including Estazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Estazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. […]
Used for
From the label: indications and usageEstazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.
Forms and strengths
- 1 mg
- 2 mg
Tablet.
On the market
- Earliest approval on file
- December 26, 1990 Prosom, Abbott; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first July 3, 1997; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.839 per tablet Estazolam 2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,940 through July 30, 2026
What is estazolam used for?
From the label: indications and usageEstazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY ). Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. […]
Conditions named in the indications of estazolam's FDA labels, with every medicine labeled for each:
From other estazolam labelsInsomnia: INDICATIONS & USAGE Estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Estazolam), Novitium Pharma LLC, effective November 11, 2022 (SPL set e1c77eb1-9cba-4e89-a03f-9fb797add4f0), via openFDA; the full label on DailyMed
What does the patient leaflet for estazolam 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 estazolam?Estazolam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (CNS) (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking estazolam with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including estazolam which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including estazolam. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take estazolam exactly as prescribed by your healthcare provider. Take estazolam exactly as your healthcare provider prescribed. Do not share your estazolam with other people. Keep estazolam in a safe place and away from children. Physical dependence and withdrawal reactions. Estazolam can cause physical dependence and withdrawal reactions, especially if you continue to take estazolam for several days to several weeks. Do not suddenly stop taking estazolam. […]
From the patient leaflet: How should I store estazolam?Store Estazolam Tablets, USP in a tightly closed child resistant container at room temperature between 20° to 25°C (68° to 77°F). Keep estazolam and all medicines out of the reach of children.
Source: FDA drug label (Estazolam), Novitium Pharma LLC, effective November 11, 2022 (SPL set e1c77eb1-9cba-4e89-a03f-9fb797add4f0), via openFDA; the full label on DailyMed
Is there a generic for estazolam (Prosom)?
The FDA approved the first generic estazolam on July 3, 1997. 3 generic applications are approved; 3 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 estazolam from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1990 earliest approval on file
- 1997 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for estazolam (Prosom)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.839 per Estazolam 2 mg tablet, up 5% from $0.801 on October 8, 2025. 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.
- Estazolam 2 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Estazolam 1 mg tablet | Generic | $0.884 per tablet | $26.52 | +30% |
| Estazolam 2 mg tablet | Generic | $0.839 per tablet | $25.18 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the estazolam label say about other medicines?
The estazolam label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name estazolam. 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 |
|---|---|---|
| Carbamazepine | drug interactions | While no in vivo drug-drug interaction studies were conducted between estazolam and inducers of CYP3A, compounds that are potent CYP3A inducers (such as carbamazepine, phenytoin, rifampin, and barbiturates) would be expected to decrease estazolam concentrations. |
| Cimetidine | drug interactions | The following are examples of drugs known to inhibit the metabolism of other related benzodiazepines, presumably through inhibition of CYP3A: nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazide, and some macrolide antibiotics. |
| Diltiazem | drug interactions | The following are examples of drugs known to inhibit the metabolism of other related benzodiazepines, presumably through inhibition of CYP3A: nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazide, and some macrolide antibiotics. |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of estazolam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE, Dependence ). |
| Fluoxetine | drug interactions | The pharmacokinetics of estazolam (C max and AUC) were not affected during multiple-dose fluoxetine, suggesting no clinically significant pharmacokinetic interaction. |
| Fluvoxamine | drug interactions | The following are examples of drugs known to inhibit the metabolism of other related benzodiazepines, presumably through inhibition of CYP3A: nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazide, and some macrolide antibiotics. |
| Itraconazole | contraindications | CONTRAINDICATIONS Estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by CYP3A (see WARNINGS and PRECAUTIONS, Drug Interactions ). |
| Ketoconazole | contraindications | CONTRAINDICATIONS Estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by CYP3A (see WARNINGS and PRECAUTIONS, Drug Interactions ). |
| Nefazodone | drug interactions | The following are examples of drugs known to inhibit the metabolism of other related benzodiazepines, presumably through inhibition of CYP3A: nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazide, and some macrolide antibiotics. |
| Phenytoin | drug interactions | While no in vivo drug-drug interaction studies were conducted between estazolam and inducers of CYP3A, compounds that are potent CYP3A inducers (such as carbamazepine, phenytoin, rifampin, and barbiturates) would be expected to decrease estazolam concentrations. |
| Rifampin | drug interactions | While no in vivo drug-drug interaction studies were conducted between estazolam and inducers of CYP3A, compounds that are potent CYP3A inducers (such as carbamazepine, phenytoin, rifampin, and barbiturates) would be expected to decrease estazolam concentrations. |
Other labels that name estazolam
Source: FDA drug label (Estazolam), Novitium Pharma LLC, effective November 11, 2022 (SPL set e1c77eb1-9cba-4e89-a03f-9fb797add4f0), via openFDA; the full label on DailyMed
What do FAERS reports show for estazolam?
The FDA Adverse Event Reporting System holds 1,940 reports that list estazolam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 305 are coded as a death and 1,042 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 estazolam?
11 other medicines are given the same way (oral) and in the same FDA class as estazolam 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 |
|---|---|---|---|---|
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
| Flurazepam | Insomnia | 1 labeler | n/a | In shortage |
| Quazepam | Insomnia | none listed | n/a | No current entry |
| Zolpidem | Insomnia | 39 labelers | $0.0344 per tablet 5 mg tablet | No current entry |
| Eszopiclone | Insomnia | 26 labelers | $0.0993 per tablet 1 mg tablet | 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to estazolam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Estazolam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other