TEMAZEPAM

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Created Feb 2021

TEMAZEPAM

  • [RESTORIL]
  • [NORMISON]

DEA CODE 2925: Schedule 4

Generic Temazepam

Generic Temazepam

About Temazepam:

  • It's used to treat sleeping problems (insomnia).
  • It can also be taken to help you relax before an operation or other medical or dental treatments. This is known as a 'pre-med'.
  • It comes as tablets or as a liquid that you swallow.
  • Temazepam belongs to a group of medicines called benzodiazepines.
  • Temazepam is available on prescription only.
  • It normally takes around 30 minutes to work.

Key Facts:

  • The most common side effects include feeling drowsy or lightheaded, and having a dry mouth.
  • It's not recommended to use temazepam for longer than 4 weeks.
  • If temazepam affects your eyesight or makes you feel sleepy, dizzy or confused, do not drive or use tools or machines until you feel OK again.
  • Do not drink alcohol when taking temazepam.
  • Temazepam can be taken by adults over the age of 18.
  • You'll usually take it once a day, half an hour before bedtime.
  • The usual dose for sleep problems is 10 to 20mg half an hour before going to bed.

What is temazepam, and how does it work (mechanism of action)?
Temazepam is a drug that is used for treating anxiety. It is in the benzodiazepine class of drugs, the same family that includes diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), flurazepam (Dalmane), lorazepam (Ativan), and others. Temazepam and other benzodiazepines act by enhancing the effects of gamma- aminobutyric acid (GABA) in the brain. GABA is a neurotransmitter (a chemical messenger that nerve cells use to communicate with each other) that inhibits many of the activities of the brain. It is believed that excessive activity in the brain may lead to anxiety or other psychiatric disorders and that temazepam reduces the activity. Temazepam increases total sleep time. The FDA approved temazepam in February 1981.

What is it?
Temazepam comes as a capsule you take by mouth. This drug is a controlled substance. It can be misused, and its use can lead to dependence. Temazepam is available as the brand-name drug Restoril. It's also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug. Temazepam may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used:
Temazepam is used for the short-term treatment of insomnia. This is a sleep problem that includes trouble falling asleep as well as waking up often during the night.

How it works:
Temazepam belongs to a class of drugs called benzodiazepines. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions. Temazepam works by increasing the action of a substance in your body called gamma aminobutyric acid (GABA). GABA sends signals through your nervous system that can improve sleep. When you take temazepam, the effects of GABA are increased in your body.

Insomnia:
Poor sleep (insomnia) is fairly common but it does not usually last for long. If you have problems sleeping, it may mean that you have difficulty getting off to sleep, or you may wake up for long periods during the night, or you may wake up too early in the morning. 'Sleeping tablets' like temazepam are considered a last resort, but are sometimes prescribed for a short period of time to help with a particularly bad spell of insomnia.

The effects of temazepam can last into the following day; it is likely to impair your reactions and your ability to drive. Do not drive and do not use tools or machines while affected.

Temazepam works by affecting the way certain natural brain chemicals (neurotransmitters) transmit messages. This has a calming effect which helps you to sleep. It works well in the short term, with one week's treatment normally being sufficient, although up to three weeks of treatment are sometimes required. If you take it for longer, the medicine may lose its effect (you may become tolerant to the effect), and when you stop it you may develop withdrawal symptoms.

When temazepam was first discovered in the mid-1960s, it was marketed as being less addictive than barbiturates. However, now it is well-known that this drug can quickly cause dependence so it is generally only prescribed for 7 to 10 days.

The dosage varies from person to person, but it is formulated in 7.5 mg, 15 mg, 22.5 mg, and 30 mg tablets.

Restoral has been known to produce strange side effects in users, such as eating, driving, or making phone calls while taking it but having no memory of the activities later.

Due to its ability to produce feelings of euphoria, misuse of temazepam is common but it can also produce uncomfortable withdrawal symptoms if the user abruptly stops taking it.

If you are having trouble falling asleep or staying asleep, Restoril may be a helpful short-term solution. However, you should always tell your doctor if you are taking any other benzodiazepines or illegal drugs before using Restoril because central nervous system depressants can produce dangerous side effects when they interact with other depressant drugs or herbal products.


Temazepam key facts:
  • Temazepam can be addictive and should not normally be taken for more than two to four weeks at a time, including a period where the dose is gradually reduced. Don't stop taking it suddenly.
  • Temazepam is only available on prescription.
  • Temazepam causes drowsiness that can last into the next day. Do not drive if affected.
  • Do not drink alcohol while taking temazepam.
  • Common temazepam side effects include feeling sleepy, dizzy, confused and less alert, numbed emotions, muscle weakness, headache and double vision.
  • Temazepam may affect your ability to drive or operate machinery as it causes drowsiness and impairs concentration. These effects may continue into the following day and can be made worse by drinking alcohol.


Class Name: Sedative/Hypnotics
Most Common Used Sedative/Hypnotics

ESTAZOLAM | FLURAZEPAM | TRIAZOLAM | TEMAZEPAM | LORAZEPAM


Temazepam is a benzodiazepine used as a hypnotic agent in the management of insomnia. Temazepam produces CNS depression at limbic, thalamic, and hypothalamic levels of the CNS. Temazepam increases the affinity of the neurotransmitter gamma-aminobutyric acid (GABA) for GABA receptors by binding to benzodiazepine receptors. Results are sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, and anxiolytic action. Benzodiazepines bind nonspecifically to benzodiazepine receptors, which affects muscle relaxation, anticonvulsant activity, motor coordination, and memory. As benzodiazepine receptors are thought to be coupled to gamma-aminobutyric acid-A (GABAA) receptors, this enhances the effects of GABA by increasing GABA affinity for the GABA receptor. Binding of the inhibitory neurotransmitter GABA to the site opens the chloride channel, resulting in a hyperpolarized cell membrane that prevents further excitation of the cell. Temazepam is used for the short-term treatment of insomnia (generally 7-10 days).

Temazepam (Rx)
Black Box Warnings:

Concomitant use of benzodiazepines and opioids may result in profound respiratory depression, coma, and death; administer concomitantly when there are no alternative options; limit dosages and durations to minimum required; monitor for signs and symptoms of respiratory depression and sedation

Addiction, abuse, and misuse:

  • On September 2020, FDA addressed serious risks of benzodiazepine addiction, abuse, and misuse, which can lead to overdose and death
  • Physical dependence can occur when taken steadily for several days to weeks, even as prescribed
  • Stopping abruptly or reducing dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening
  • Assess each patient's risk prior to prescribing and monitor regularly for the development of these behaviors or conditions

What is the most important information I should know about temazepam?
  • Do not use if you are pregnant. This medicine can cause birth defects or life-threatening withdrawal symptoms in a newborn.
  • Temazepam may be habit-forming. Misuse of habit-forming medicine can cause addiction, overdose, or death.
  • Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting, swelling of your face, lips, tongue, or throat.

Number of drug poisoning deaths due to temazepam use in England and Wales from 1993 to 2019
Temazepam Deaths England and Wales

Liver:
As with most benzodiazepines, temazepam therapy has not been associated with serum aminotransferase or alkaline phosphatase elevations, and clinically apparent liver injury from temazepam has not been reported and must be very rare, if it occurs at all.

Temazepam Hepatotoxicity:
Temazepam, like other benzodiazepines, is rarely associated with serum ALT elevations, and clinically apparent liver injury from temazepam is extremely rare, if it occurs at all. There have been no case reports of symptomatic, acute liver injury from temazepam. Cases of clinically apparent liver injury have been reported with other benzodiazepines including alprazolam, chlordiazepoxide, clonazepam, diazepam, flurazepam and triazolam. The clinical pattern of acute liver injury from benzodiazepines is typically cholestatic and mild-to-moderate in severity with a latency of 1 to 6 months. Fever and rash are uncommon as is autoantibody formation.

E Likelihood score: E (unlikely cause of clinically apparent liver injury).


Temazepam
Duration:

Temazepam's brand name is Restoril. It is a hypnotic benzodiazepine with effects similar to clonazepam, frequently prescribed as a sleep aid. Some users report mild euphoria alongside the hypnotic effects.

RouteOnsetDurationAfter Effects
Tripsit Factsheets
All ROAs:20-90 minutes6-10 hours6-12 hours
Temazepam Duration
Avoid:
All other CNS depressants.
Effects:
Euphoria, empathy, insight, brightened colour, Closed/Open eye visuals, enhanced tactile sensation, mental/physical stimulation, decreased appetite, pupil dilation, restlessness, change in perception, ego softening, sweating/chills, muscle tension, confusion, insomnia.

Pharmacokinetics:

  • Absorption:
    Well absorbed through the GI tract when administered orally.
  • Distribution:
    Widely distributed throughout the body. Drug is 96% protein-bound.
  • Metabolism:
    Metabolized in the liver primarily to inactive metabolites.
  • Excretion:
    Metabolites are excreted in urine as glucuronide conjugates. Half-life of drug is 10 to 20 hours.

Important Information:

Never take temazepam if you do not have at least 7 to 8 hours to sleep before being active again.

Do not use temazepam if you are pregnant. Temazepam can cause birth defects or life-threatening withdrawal symptoms in a newborn. Use effective birth control to prevent pregnancy while taking this medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking temazepam and talk with your doctor about another treatment for your sleep disorder.

Fatal side effects can occur if you take temazepam with alcohol, with opioid medicine, or with other drugs that cause drowsiness or slow your breathing.

Temazepam may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.Misuse of habit-forming medicine can cause addiction, overdose, or death.

Temazepam may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take this medication only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol while you are taking temazepam.

Do not share this medicine with another person, even if they have the same symptoms you have.

Interactions:

Drug Interactions (368) Alcohol/Food Interactions (2) Disease Interactions (10)


What other drugs will affect Temazepam?
Taking temazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Other drugs may interact with temazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 368 drugs are known to interact with Temazepam.

  • 26 major drug interactions
  • 313 moderate drug interactions
  • 29 minor drug interactions

Temazepam drug usage

142nd most prescribed medicine in the United States for 2017

Used for Difficulty Sleeping:
This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect.

Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

Before Using:
Tell your doctor or pharmacist your medical history, especially of:

  • kidney disease
  • liver disease
  • lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea)
  • mental/mood problems (such as depression, thoughts of suicide)
  • personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
  • personal or family history of sleepwalking
  • a certain muscle disease (myasthenia gravis)

Precautions:

Since this drug makes you drowsy, do not drive, use machinery, or do anything that needs alertness until you can do it safely.

Alcohol or marijuana (cannabis) can make you more drowsy. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

WARNINGS:

Taking temazepam with opioid medications (such as codeine, hydrocodone) may increase your risk of very serious side effects, including death.

To lower your risk, your doctor should have you take the smallest dose of temazepam that works, and take it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

User Reviews:

392 Total User Reviews
Temazepam Oral Read Reviews
Condition: Cronic Trouble Sleeping (360 Reviews):
Effectiveness(3.38)

Ease of Use(4.32)

Satisfaction(3.19)

Temazepam Pharmaceutical Chemical Safety Information
Chemical Safety Summary:
INCHEM
Main risks and target organs:
Central nervous system, causing depression of respiration and consciousness.
Summary of clinical effects:
Central nervous system (CNS) depression and coma, or paradoxical excitation, but deaths are rare when benzodiazepines are taken alone. Deep coma and other manifestations of severe CNS depression are rare. Sedation, somnolence, diplopia, dysarthria, ataxia and intellectual impairment are the most common adverse effects of benzodiazepines. Overdose in adults frequently involves co- ingestion of other CNS depressants, which act synergistically to increase toxicity. Elderly and very young children are more susceptible to the CNS depressant action. Intravenous administration of even therapeutic doses of benzodiazepines may produce apnoea and hypotension. Dependence may develop with regular use of benzodiazepines, even in therapeutic doses for short periods. If benzodiazepines are discontinued abruptly after regular use, withdrawal symptoms may develop. The amnesia produced by benzodiazepines can have medico-legal consequences.
Diagnosis:
The clinical diagnosis is based upon the history of benzodiazepine overdose and the presence of the clinical signs of benzodiazepine intoxication. Benzodiazepines can be detected or measured in blood and urine using standard analytical methods. This information may confirm the diagnosis but is not useful in the clinical management of the patient. A clinical response to flumazenil, a specific benzodiazepine antagonist, also confirms the diagnosis of benzodiazepine overdose, but administration of this drug is rarely justified.
First aid measures and management principles:
Most benzodiazepine poisonings require only clinical observation and supportive care. It should be remembered that benzodiazepine ingestions by adults commonly involve co- ingestion of other CNS depressants and other drugs. Activated charcoal normally provides adequate gastrointestinal decontamination. Gastric lavage is not routinely indicated. Emesis is contraindicated. The use of flumazenil is reserved for cases with severe respiratory or cardiovascular complications and should not replace the basic management of the airway and respiration. The routine use of flumazenil is contraindicated because of potential complications, including seizures. Renal and extracorporeal methods of enhanced elimination are not effective.

Pediatric:
Appropriate studies have not been performed on the relationship of age to the effects of temazepam in the pediatric population.

Safety and efficacy have not been established.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving temazepam.

Other Medical Problems:
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol or abuse, or history of
  • Breathing problems or lung disease
  • Depression, history of
  • Drug abuse or dependence, or history of
  • Mental health problems, history of - Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease - Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Breastfeeding:

Summary of Use During Lactation:

Because of the low levels of temazepam in breastmilk and its relatively short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

Taking the bedtime dose after the infant's last feeding of the day may minimize the dose received by an older infant who is sleeping through the night.

Effects in Breastfed Infants:
Ten infants who less than 15 days old were breastfed by mothers who had taken temazepam 10 or 20 mg (0.16 to 0.32 mg/kg) at bedtime once daily for at least 2 days. None of the infants had any observable adverse reactions.

In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. One mother took temazepam while breastfeeding and reported no sedation in her infant.

Alternate Drugs to Consider:

MotherToBaby PDF Temazepam

EMC PDF Temazepam

EMC PDF Temazepam Oral Solution

Medsafe PDF Normison Temazepam Tablet

CaymanChem PDF Temazepam

In sleep laboratory studies, temazepam significantly decreased the number of nightly awakenings, but has the drawback of distorting the normal sleep pattern

  • An intermediate acting benzodiazepine and hypnotic
  • Used to treat insomnia
  • It is available as a generic medication
  • Should generally be used for less than ten days
  • It is taken by mouth
  • Effects generally begin within an hour and last for up to eight hours
  • Common side effects include sleepiness, anxiety, confusion, and dizziness.
  • Serious side effects may include hallucinations, abuse, anaphylaxis, and suicide.
  • Use is generally not recommended together with opioids
  • If the dose is rapidly decreased withdrawal may occur
  • Use during pregnancy or breastfeeding is not recommended

Street terms:
Street terms for temazepam include:
  • King kong pills
  • Jellies
  • Jelly
  • Edinburgh eccies
  • Tams
  • Terms
  • Mazzies
  • Temazies
  • Tammies
  • Temmies
  • Beans
  • Eggs
  • Green eggs
  • Wobbly eggs
  • Knockouts
  • Hardball
  • Norries
  • Oranges
  • Rugby balls
  • Ruggers
  • Terminators
  • Red and blue
  • No-gos
  • Num nums
  • Blackout
  • Green devils
  • Drunk pills
  • Brainwash
  • Mind erasers
  • Neurotrashers
  • Tem-tem's (with buprenorphine)
  • Mommy's big helper
  • Vitamin T
  • Big T
  • TZ
  • The Mazepam
  • Resties

In 2017, it was the 142nd most commonly prescribed medication in the United States, with more than four million prescriptions

The United States Air Force uses temazepam as one of the hypnotics approved as a 'no-go pill' to help aviators and special-duty personnel sleep in support of mission readiness.

Temazepam is a drug with a high potential for misuse

  
How to Take Temazepam and Dose of Temazepam - Find out how to take Temazepam (drug) and its dose. Describes the best time to take the drug and precautions if any that should be followed. Caution should be exercised in patients with history of ...
Monday December 15, 2014 - medindia.net

Temazepam : Interaction with Food, Herbs and Alcohol - Interaction of Temazepam with Food, Herbs and Alcohol - For your own safety It is important to understand and avoid the drug-food interaction and how to take the medication. Drug-food interaction ...
Thursday August 13, 2020 - medindia.net

Temazepam-medicinkopen facilitates its consumers with Oxazepam without a Prescription in the Netherlands - Temazepam-medicinkopen is pleased to announce that Oxazepam, a medication commonly used to treat anxiety and insomnia, is now available for purchase without a prescription through its online pharmacy.
Sunday January 29, 2023 - markets.buffalonews.com

Clozapine/Benzodiazepines Interactions - Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Serious. These medicines may interact and cause very harmful effects.
Monday May 15, 2017 - webmd.com

Benzodiazepines/Selected Stimulants Interactions - Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Let your healthcare professionals (e.g. doctor or pharmacist) know that you are ...
Thursday October 31, 2019 - webmd.com

Discovery of illegal diazepam and temazepam pills hailed as 'fantastic result' - “We want to emphasise that although these were Class C drugs, they are still linked ... muscle spasms and fits, while temazepam is a medication used to treat insomnia.
Wednesday February 12, 2020 - lancashiretelegraph.co.uk

Ledger's death caused by accidental overdose - alprazolam is also an anti-anxiety drug sold under such names as Xanax. Temazepam, sold under such names as Restoril and Euhypnos, is a sleeping agent. Doxylamine, an antihistamine, can be ...
Thursday August 06, 2020 - edition.cnn.com

Animal abuser jailed over shocking treatment of dogs gets suspended sentence for drug dealing - This is the heartless hunter who has avoided jail for dealing cannabis and possessing illegal prescription pills.
Tuesday January 31, 2023 - sundayworld.com

Nearly 1 in 5 Americans use a medication to help them sleep - Nearly 20% of American adults use a drug to help them sleep, either occasionally or regularly, health officials reported Wednesday.
Tuesday January 24, 2023 - upi.com

Women and Psychopharmacology - Oral contraceptives differentially affect the blood levels of various benzodiazepines, increasing levels of diazepam, and decreasing levels of temazepam. Drugs such as carbamazepine can interfere ...
Thursday February 02, 2023 - medscape.com

Drug Overdose Deaths Among Women Aged 30–64 Years — United States, 1999–2017 - Analyses were restricted to deaths with an underlying cause of death based on the following ICD-10 codes for drug overdoses: X40–X44 (unintentional), X60–X64 (suicide), X85 (homicide), and Y10 ...
Monday January 02, 2023 - medscape.com

London, Ont. police seize over $100K in drug and gun bust - On Thursday, police were involved in an active investigation at a residence on Terrence Street and seized an estimated over $100,000 worth of drugs and firearms.
Friday January 20, 2023 - msn.com

  
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