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 →
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.
How to Take It
Take temazepam capsules right before you go to bed. The usual dose for adults is 15 mg, but some may need 7.5 mg or 30 mg. If you are elderly or weak, your doctor may start you on 7.5 mg. Talk to your doctor about the right dose for you.
This is a plain-language summary of temazepam's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if temazepam will harm your unborn baby. Talk to your doctor if you are breastfeeding.
This is a plain-language summary of temazepam's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, skip it and take your next dose at your regular time. Do not take two doses at once.
This is a plain-language summary of temazepam's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store temazepam capsules at room temperature, away from light and moisture.
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
- Tiredness
Tiredness
2,806 reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,403 reports
- Discomfort
Discomfort
2,274 reports
- Head pain
Head pain
2,237 reports
- Poisoning from different substances
Poisoning from different substances
2,129 reports
- Loose stools
Loose stools
1,791 reports
- Difficulty breathing
Difficulty breathing
1,757 reports
- Trouble sleeping
Trouble sleeping
1,674 reports
- Death
Death
1,662 reports
- Feeling unsteady
Feeling unsteady
1,655 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) 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.
What to do: No dose changes are usually needed when taking these two medications together. You can follow your normal schedule.
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.
What to do: No special changes are usually needed when taking these two drugs at the same time.
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.
What to do: Your doctor may need to monitor how well your sleep medicine is working and adjust the dose if needed.
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.
What to do: Your doctor may need to adjust your dose of the sleep medication. Tell your provider if you are having trouble sleeping while taking both drugs.
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.
What to do: Your doctor may need to adjust your dose of temazepam if you find it is not working as well as it should.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is temazepam safe during pregnancy?
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.
Compare with temazepam →
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 →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on temazepam
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: December 11, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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