Prescription medicine
Temazepam Brand names: Restoril
Temazepam (Restoril) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.0767 per temazepam 15 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the temazepam FDA label on DailyMed (effective June 9, 2026); the NDA 18163 record on Drugs@FDA; every temazepam label on DailyMed.
Highlights of the record
FDA label of June 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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 ). The use of benzodiazepines, including Restoril, 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 Restoril and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( see WARNINGS ). The continued use of benzodiazepines, including Restoril, 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 Restoril after continued use may precipitate acute withdrawal reactions, which can be life-threatening. […]
Used for
From the label: indications and usageRestoril ® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days).
Forms and strengths
- 7.5 mg
- 15 mg
- 22.5 mg
- 30 mg
Capsule.
On the market
- Earliest approval on file
- February 27, 1981 Restoril, Specgx Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first July 10, 1986; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 20 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0767 per capsule Temazepam 15 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest December 22, 2016; 1 more by firms not listed as its makers
- FAERS reports
- 37,475 through July 30, 2026
What is temazepam used for?
From the label: indications and usageRestoril ® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Restoril ® (temazepam) should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Conditions named in the indications of temazepam's FDA labels, with every medicine labeled for each:
From other temazepam labelsInsomnia: INDICATIONS AND USAGE Restoril ® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days).
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (RESTORIL), SpecGx LLC, effective June 9, 2026 (SPL set bc56f7fd-1aaf-48ff-8aa7-d467e59e1015), via openFDA; the full label on DailyMed
What does the patient leaflet for temazepam 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 RESTORIL?RESTORIL 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 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 RESTORIL and opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including RESTORIL 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 RESTORIL. 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 RESTORIL as prescribed by your healthcare provider. Take RESTORIL exactly as your healthcare provider prescribed. Do not share your RESTORIL with other people. Keep RESTORIL in a safe place and away from children. Physical dependence and withdrawal reactions. RESTORIL can cause physical dependence and withdrawal reactions. Do not suddenly stop taking RESTORIL. […]
From the patient leaflet: How should I store RESTORIL?Store RESTORIL at room temperature between 68°F to 77°F (20°C to 25°C). Keep RESTORIL and all medicines out of the reach of children.
Source: FDA drug label (RESTORIL), SpecGx LLC, effective June 9, 2026 (SPL set bc56f7fd-1aaf-48ff-8aa7-d467e59e1015), via openFDA; the full label on DailyMed
Is there a generic for temazepam (Restoril)?
The FDA approved the first generic temazepam on July 10, 1986. 17 generic applications are approved; 9 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 temazepam from 20 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1981 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for temazepam (Restoril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0767 per Temazepam 15 mg capsule, 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.
- Temazepam 15 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Temazepam 15 mg capsule | Generic | $0.0767 per capsule | $2.30 | +0.5% |
| Temazepam 22.5 mg capsule | Generic | $1.55 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $46.48 | -18% |
| Temazepam 30 mg capsule | Generic | $0.0893 per capsule | $2.68 | -0.1% |
| Temazepam 7.5 mg capsule | Generic | $0.834 per capsule | $25.01 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has temazepam been recalled?
The FDA's Enforcement Report lists 2 recalls naming temazepam since 2013: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of temazepam and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 22, 2016 | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Failed Stability Specifications |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 200 mg Elemental … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the temazepam label say about other medicines?
The temazepam label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name temazepam. 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 |
|---|---|---|
| Cimetidine | drug interactions | The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling. |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of Restoril 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 ). |
Other labels that name temazepam
Source: FDA drug label (RESTORIL), SpecGx LLC, effective June 9, 2026 (SPL set bc56f7fd-1aaf-48ff-8aa7-d467e59e1015), via openFDA; the full label on DailyMed
What do FAERS reports show for temazepam?
The FDA Adverse Event Reporting System holds 37,475 reports that list temazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,537 are coded as a death and 12,572 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 temazepam?
11 other medicines are given the same way (oral) and in the same FDA class as temazepam 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 |
|---|---|---|---|---|
| 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 |
| 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)
How does temazepam compare with medicines for the same use?
4 side-by-side pages set temazepam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to temazepam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Temazepam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other