Prescription medication · Benzodiazepine (Hypnotic)
temazepam
Also sold as Restoril. Temazepam capsules are used to treat insomnia.
Data updated 2026-05-15
- 36,917
- FDA reportsModerately reported
- 7
- InteractionsFew interactions
- $0.06
- Generic price (NADAC)
What the data shows
temazepam (Restoril) is a prescription Benzodiazepine (Hypnotic), reported at a middle-of-the-pack volume (36,917 FDA reports), with 7 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
temazepam (Restoril) is a prescription Benzodiazepine (Hypnotic). Temazepam capsules are used to treat insomnia.
Temazepam is a medicine that helps you sleep. It is used for a short time to treat insomnia.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.06/unit
Generic Available
Yes (6 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: TEMAZEPAM 15 MG CAPSULE
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -18.4% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| October 23, 2024 | $0.0781/EA | - | 1 |
| December 18, 2024 | $0.0637/EA | -18.4% | 12 |
What it does
Temazepam capsules are used to treat insomnia.
Common side effects
Drowsiness, Headache, Fatigue
Key warnings
Taking temazepam with opioid medicines can cause very serious problems, including slowed breathing, coma, and death.
The sections below are summarized in plain English from temazepam's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Temazepam belongs to a class of drugs called benzodiazepines. It works by slowing down activity in the brain. This helps you to relax and fall asleep.
Side Effects (from patient reports)
Based on 36,917 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for temazepam, by number of reports
- Fatigue
Fatigue
2,804 reports
- Nausea
Nausea
2,399 reports
- Pain
Pain
2,271 reports
- Headache
Headache
2,234 reports
- Toxicity To Various Agents
Toxicity To Various Agents
2,129 reports
- Diarrhoea
Diarrhoea
1,790 reports
- Dyspnoea
Dyspnoea
1,757 reports
- Insomnia
Insomnia
1,672 reports
- Death
Death
1,664 reports
- Dizziness
Dizziness
1,654 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for temazepam each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where temazepam sits
temazepam has more FDA adverse-event reports than 68% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is temazepam; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 36,917 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
36,917
Reports Mentioning Death
7,405
20.1% of reports — not proof of cause
Hospitalization Reports
12,410
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 2,804 |
| 3 | NAUSEA | 2,399 |
| 4 | PAIN | 2,271 |
| 5 | HEADACHE | 2,234 |
| 6 | TOXICITY TO VARIOUS AGENTS | 2,129 |
| 7 | DIARRHOEA | 1,790 |
| 8 | DYSPNOEA | 1,757 |
| 9 | INSOMNIA | 1,672 |
| 10 | DEATH | 1,664 |
| 11 | DIZZINESS | 1,654 |
| 12 | FALL | 1,632 |
| 14 | ANXIETY | 1,497 |
| 15 | ASTHENIA | 1,435 |
| 16 | BACK PAIN | 1,401 |
| 17 | COMPLETED SUICIDE | 1,357 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Taking temazepam with opioid medicines can cause very serious problems, including slowed breathing, coma, and death. Only take them together if there are no other options. Temazepam can be misused or lead to addiction, which can result in overdose or death. Using temazepam for a long time can cause you to become dependent on it. Stopping it suddenly can cause life-threatening withdrawal symptoms. Your doctor will slowly lower your dose to prevent withdrawal.
Known Drug Interactions
Temazepam Nitrazepam Lorazepam No Dose Adjustment Temazepam, Nitrazepam, Lorazepam: For benzodiazepines which are not metabolized by CYP3A (e.g., temazepam, nitrazepam, lorazepam), a clinically important interaction with clarithromycin is unlikely.
Mechanism: These two drugs do not interfere with each other because temazepam is not broken down by the same liver process that clarithromycin affects.
7.6 Temazepam Under steady-state conditions for duloxetine (20 mg qhs) and temazepam (30 mg qhs), the pharmacokinetics of duloxetine were not affected by co-administration.
Mechanism: These two medications do not change how the body processes duloxetine when they are taken together.
Other Drugs Clinical effect Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam.
Mechanism: Estradiol can cause your body to get rid of temazepam faster than usual, which might make it less effective.
CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid and temazepam.
Mechanism: Birth control hormones can cause your body to clear out this sleep medicine faster than it should. This can make the sleep medicine feel weaker or not work at all.
Other Drugs Clinical effect Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam.
Mechanism: Birth control pills can cause your body to break down temazepam more quickly, which lowers the amount of medicine in your blood.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
How long can I take temazepam?
Can I drink alcohol while taking temazepam?
What should I do if I feel sleepy the next day?
Can I drive after taking temazepam?
What are the symptoms of temazepam withdrawal?
Can I take temazepam with other medications?
What if temazepam stops working?
Is temazepam addictive?
Can I share my temazepam with someone else?
What do I do if I think I have taken too much temazepam?
What are the common side effects of temazepam?
Does temazepam interact with other medications?
What drug class is temazepam?
What pregnancy or breastfeeding source fields are listed for temazepam?
Related Medications in Benzodiazepine (Hypnotic)
Other drugs grouped near temazepam - same-class peers and common alternatives.
eszopiclone
Lunesta
Eszopiclone (Lunesta) is a medicine that helps you fall asleep and stay asleep.
Compare with temazepam →
lemborexant
Dayvigo
Dayvigo is a medicine that can help you fall asleep and stay asleep.
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melatonin
Melatonin
Melatonin is a hormone supplement that can help with sleep.
Compare with temazepam →
ramelteon
Rozerem
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster.
Compare with temazepam →
suvorexant
Belsomra
Belsomra is a prescription medicine used to treat insomnia.
Compare with temazepam →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for temazepam: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 36,917.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 20.06%.
- metolazone Δ 0.14 pts · 10,872 reports · Thiazide-Like Diuretic 19.91%death share
- amikacin Δ 0.16 pts · 16,238 reports · Aminoglycoside Antibiotic 20.22%death share
- atropine Δ 0.17 pts · 7,881 reports · Anticholinergic 20.23%death share
- vancomycin Δ 0.20 pts · 55,549 reports · Glycopeptide Antibiotic 19.85%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for temazepam
The FDA label for temazepam (sold under brand names such as Restoril) classifies it as a prescription-only medication in the Benzodiazepine (Hypnotic) class. Temazepam capsules are used to treat insomnia. Official labeling lists 7 commonly reported side effects, including Drowsiness, Headache, Fatigue.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 36,917 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.06.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 11, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages