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temazepam

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Brand names: Restoril

Benzodiazepine (Hypnotic) Rx

Temazepam is a medicine that helps you sleep. It is used for a short time to treat insomnia.

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.

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.

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.

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.

Storage

Store temazepam capsules at room temperature, away from light and moisture.

Side Effects (from patient reports)

Based on 21,148 FDA adverse event reports.

Tiredness
2,806
Medicine not working
2,415
Feeling sick to your stomach
2,403
Discomfort
2,274
Head pain
2,237
Poisoning from different substances
2,129
Loose stools
1,791
Difficulty breathing
1,757
Trouble sleeping
1,674
Death
1,662

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

Death-Related Reports

7,405

Hospitalization Reports

12,410

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 20,878 (60%)
Male 13,668 (39%)

Age Distribution

0–17 212
18–44 4,892
45–64 10,159
65–74 5,183
75+ 4,589

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 2,804
2 DRUG INEFFECTIVE 2,413
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
13 OFF LABEL USE 1,587
14 ANXIETY 1,497
15 ASTHENIA 1,435

Reactions in Death Reports

DEATH 1,658
TOXICITY TO VARIOUS AGENTS 1,656
COMPLETED SUICIDE 1,349
OVERDOSE 551
DRUG ABUSE 537
CARDIO-RESPIRATORY ARREST 379
CARDIAC ARREST 377
FATIGUE 310
PAIN 302
PNEUMONIA 292

Reactions in Hospitalization Reports

DYSPNOEA 1,055
PNEUMONIA 1,022
NAUSEA 978
FALL 911
FATIGUE 880
DIARRHOEA 801
VOMITING 781
PAIN 756
ASTHENIA 727
PYREXIA 676

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.

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Common Questions

How long can I take temazepam?
Temazepam is meant for short-term use, usually 7 to 10 days.
Can I drink alcohol while taking temazepam?
No, you should not drink alcohol while taking temazepam. It can increase the risk of serious side effects.
What should I do if I feel sleepy the next day?
Talk to your doctor. They may need to adjust your dose.
Can I drive after taking temazepam?
Do not drive or operate heavy machinery until you know how temazepam affects you.
What are the symptoms of temazepam withdrawal?
Withdrawal symptoms can include anxiety, trouble sleeping, shaking, and seizures.
Can I take temazepam with other medications?
Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements.
What if temazepam stops working?
Talk to your doctor if temazepam is not helping you sleep.
Is temazepam addictive?
Yes, temazepam can be addictive if used for a long time.
Can I share my temazepam with someone else?
No, never share your medicine with anyone else.
What do I do if I think I have taken too much temazepam?
Seek emergency medical attention right away.
What are the common side effects of temazepam?
The most commonly reported side effects of temazepam include Drowsiness, Headache, Fatigue, Nervousness, Lethargy. Based on 21,148 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does temazepam interact with other medications?
Yes, temazepam has 7 known drug interactions. Notable interactions include clarithromycin, duloxetine, estradiol. Always inform your doctor about all medications you are taking.
What drug class is temazepam?
temazepam belongs to the Benzodiazepine (Hypnotic) drug class. It requires a prescription (Rx). Temazepam capsules are used to treat insomnia.
Is temazepam safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if temazepam will harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 21,148 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

All federal data sources used on this page