Prescription medicine
Quazepam First approved as Doral
Quazepam (Doral) is a prescription medicine with an FDA approval on record since 1985. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the quazepam FDA label on DailyMed (effective October 23, 2025, Atland Pharmaceuticals, LLC); the NDA 18708 record on Drugs@FDA; every quazepam label on DailyMed.
Highlights of the record
FDA label of October 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. 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 ( 5.1 ), Drug Interactions ( 7 )]. The use of benzodiazepines, including Quazepam Tablets, 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 Quazepam Tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including Quazepam Tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. […]
Used for
From the label: indications and usageQuazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.
Forms and strengths
- 15 mg
Tablet.
On the market
- Earliest approval on file
- December 27, 1985 Doral, Galt Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- June 3, 2028 Doral tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 300 through July 30, 2026
What is quazepam used for?
From the label: indications and usageQuazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Quazepam Tablets has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Quazepam Tablets is generally not necessary or recommended. […]
Conditions named in the indications of quazepam's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Quazepam), NDA018708 (Galt Pharms), as published by Atland Pharmaceuticals, LLC, effective October 23, 2025 (SPL set f7d63f3f-5303-48ab-bce2-35fd62c45799), via openFDA; the full label on DailyMed
What does the patient leaflet for quazepam 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 Quazepam Tablets?Quazepam Tablets is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if 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 Quazepam Tablets with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Quazepam Tablets 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 Quazepam Tablets. These serious side effects may 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 Quazepam Tablets as prescribed by your healthcare provider Take Quazepam Tablets exactly as your healthcare provider prescribed. Do not share your Quazepam Tablets with other people. Keep Quazepam Tablets in a safe place and away from children. Physical dependence and withdrawal reactions. Quazepam Tablets can cause physical dependence and withdrawal reactions. Do not suddenly stop taking Quazepam Tablets. […]
From the patient leaflet: How should I store Quazepam Tablets?Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep Quazepam Tablets and all medicines out of the reach of children.
Source: FDA drug label (Quazepam), NDA018708 (Galt Pharms), as published by Atland Pharmaceuticals, LLC, effective October 23, 2025 (SPL set f7d63f3f-5303-48ab-bce2-35fd62c45799), via openFDA; the full label on DailyMed
Is there a generic for quazepam (Doral)?
No generic quazepam is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Doral tablets, the last expiring on June 3, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the quazepam label say about other medicines?
The quazepam label names 1 other medicine in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Flumazenil | warnings and precautions | Abrupt discontinuation or rapid dosage reduction of Quazepam Tablets 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 ( 9.3 )]. |
Source: FDA drug label (Quazepam), NDA018708 (Galt Pharms), as published by Atland Pharmaceuticals, LLC, effective October 23, 2025 (SPL set f7d63f3f-5303-48ab-bce2-35fd62c45799), via openFDA; the full label on DailyMed
What do FAERS reports show for quazepam?
The FDA Adverse Event Reporting System holds 300 reports that list quazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 136 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.
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 quazepam?
11 other medicines are given the same way (oral) and in the same FDA class as quazepam 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 |
| Estazolam | Insomnia | 3 labelers | $0.839 per tablet 2 mg tablet | No current entry |
| Flurazepam | Insomnia | 1 labeler | n/a | In shortage |
| 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 quazepam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Quazepam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other