QUAZEPAM

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Created Jan 2021

QUAZEPAM

  • [DORAL]
  • [DORMALIN]

DEA CODE 2881: Schedule 4

Quazepam is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Quazepam interact preferentially with the benzodiazepine-1 (BZ1) receptors. Most common adverse reactions (>1%): drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia. Downward of CAN depressant dose adjustment may be necessary due to additive effects.

Quazepam Definition:

A benzodiazepine used as a hypnotic agent. It is of medium potency and is highly lipid soluble, enabling rapid penetration of the blood - brain barrier and resulting in rapid onset of effects. Because its metabolic products are eliminated slowly, quazepam may accumulate in the body, leading to unwanted daytime sedation. U.S. trade name: Doral.

Quazepam is unique in its drug properties in two ways:

  1. Several medications from the same class of drugs have an effect called rebound insomnia. This means that the insomnia becomes worse than the original insomnia when the drug is used for extended periods. Quazepam has a minimal tendency to cause rebound insomnia.
  2. Secondly, quazepam is eliminated from the body slowly. This gives quazepam advantage over certain other medications in the benzodiazepine class, such as alprazolam or halazepam, in that patients do not experience earlymorning insomnia, since there is still enough medication to induce sleep in the very early morning hours.

Quazepam's sedating effect that reduces insomnia lasts only for about four weeks of continuous use. The medication is most effective for an intermediate-term treatment of insomnia (two weeks), rather than a long duration of treatment of over four weeks. Hence, long-term treatment for insomnia with quazepam should be avoided.

Quazepam comes in 7.5-mg and 15-mg tablets

Doral

Doral (Quazepam)

Doral is a prescription drug and the brand name for the generic drug quazepam. It is a benzodiazepine that is used to treat sleep problems in people who have difficulties falling asleep, continually wake very early in the morning, or have trouble staying asleep at night. Doral comes in the form of an orange-colored tablet and a typical dose is usually 7.5 mg, but that can also be increased to 15 mg if necessary. Since it is a longer-acting benzodiazepine, it generally causes fewer side effects than other benzodiazepines, but if it is used incorrectly or purposely abused, it can still cause dependence and addiction. If you are taking this medication for insomnia, it is extremely important that you use it exactly as it was prescribed by your doctor. People who misuse benzodiazepines like Doral or even who use them as prescribed for an extended amount of time can become addicted. Doral is similar to the sleep medications Ambien and Sonata and works by targeting only the GABA receptors in the brain that are responsible for sleep. When the drug is consumed, it provides the user with a calming and sedating effect that helps them fall asleep and stay asleep. Compared to other benzodiazepines, Doral has a lower risk of addiction, but dependence and addiction are still very possible. A person may develop a Doral addiction if he or she takes very large dosages of the drug or uses it for a long period of time.

Doral (quazepam)
Maximum Dosage:
Prescribers Digital Reference
Adults:15 mg/day PO.
Elderly15 mg/day PO.
Adolescents:Safety and efficacy have not been established.
Children:Safety and efficacy have not been established.

Prescribed for:
  • Difficulty sleeping

Used for:
This medication is used for the short-term treatment of patients with trouble sleeping (insomnia).

It is generally used for 7-10 days.

It may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer period of time. Quazepam belongs to a class of medications called benzodiazepines.

It acts on your brain to produce a calming effect.

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

  • liver disease
  • kidney disease
  • mental/mood problems (e.g., depression, panic disorder)
  • lung problems (e.g., pulmonary insufficiency, sleep apnea)
  • seizures
  • personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)

Precautions:

  • This drug may make you dizzy or drowsy or temporarily blur your vision.
  • Alcohol or marijuana (cannabis) can make you more dizzy or drowsy.
  • Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely.
  • Avoid alcoholic beverages.
  • Talk to your doctor if you are using marijuana (cannabis).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, loss of coordination, and confusion. These side effects can increase the risk of falling.

WARNINGS:

Taking quazepam 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 quazepam 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.

Quazepam
Duration:

Benzodiazepine derivate drug, noral is prescribed for short term treatment of insomnia, and sleep maintenance. its MOA is very similar to Ambien and Sonata and substitutes for those in animal studies.

RouteOnsetDurationAfter Effects
Tripsit Factsheets
All ROAs:10-30 minutes6-12 hours1-24 hours
Quazepam Duration
Summary:
Benzodiazepine derivate drug, doral is prescribed for short term treatment of insomnia, and sleep maintenance. its MOA is very similar to Ambien and Sonata and substitutes for those in animal studies.

Pharmacokinetics

  • Absorption: Readily absorbed from GI tract
  • Onset: 30 min.
  • Peak: 2 h.
  • Distribution: Crosses placenta; distributed into breast milk.
  • Metabolism: Metabolized in liver to active metabolites.
  • Elimination: Excreted in urine and feces.
  • Half-Life: 39 h.

Important Information:

You should not use quazepam if you have sleep apnea or a chronic breathing disorder.

Do not drink alcohol while taking quazepam or for several days after you stop taking quazepam.

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity.

Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have hives, nausea and vomiting, snoring, difficult breathing, or swelling of your face, lips, tongue, or throat.

Do not drink alcohol while taking quazepam or for several days after you stop taking this medicine.

Quazepam may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Interactions:

Drug Interactions (385) Alcohol/Food Interactions (2) Disease Interactions (10)


What other drugs will affect Quazepam?
Small amounts of quazepam can remain in your body for several days after you stop taking it. Other medicines you use during that time may cause drug interactions. Taking quazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures. Other drugs may interact with quazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

A total of 385 drugs are known to interact with Quazepam.

  • 26 major drug interactions
  • 324 moderate drug interactions
  • 35 minor drug interactions

What is the most important information I should know about quazepam (Doral)?
  • You should not use quazepam if you have sleep apnea or a chronic breathing disorder.
  • Do not drink alcohol while taking quazepam or for several days after you stop taking this medicine.

    Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity.

  • Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have:
    • Hives
    • Nausea and vomiting
    • Snoring
    • Difficult breathing
    • Swelling of your face, lips, tongue, or throat

Doral (quazepam tablets)
Side Effects:
Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have signs of an allergic reaction: hives; nausea and vomiting; snoring, difficulty breathing; swelling of your face, lips, tongue, or throat.
RxList
Call your doctor at once if you have:
  • confusion, agitation, aggression
  • unusual behavior (decreased inhibition, feeling more outgoing than normal)
  • hallucinations (seeing or hearing things that are not real)
  • suicidal thoughts or actions
  • worsening depression
  • memory problems
  • worsening insomnia
Common side effects may include:
  • daytime drowsiness (or during hours when you are not normally sleeping)
  • headache, dizziness
  • dry mouth
  • upset stomach
  • feeling very tired
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Doral (quazepam) (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

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

Quazepam Hepatotoxicity:
Quazepam, like other benzodiazepines, is rarely associated with serum ALT elevations, and clinically apparent liver injury from quazepam is extremely rare, if it occurs at all. There have been no case reports of symptomatic, acute liver injury from quazepam, but it has not been available for very long. 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).


Pediatric:
Appropriate studies have not been performed on the relationship of age to the effects of quazepam in children.

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 quazepam in the elderly. However, elderly patients are more likely to have confusion, dizziness, or falls and age-related heart, liver, or kidney problems which may require an adjustment in the dose for patients receiving quazepam.

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 abuse, history of
  • Breathing problems or lung disease
  • Depression
  • Drug abuse or dependence, history of
  • Mental health problems - Use with caution. May make these conditions worse
  • Pulmonary insufficiency
  • Sleep apnea (temporary stopping of breathing during sleep) - Should not be used in patients with these conditions

Breastfeeding:

Summary of Use During Lactation:
No information is available on the long-term use of quazepam during breastfeeding.

Because the drug and metabolites could accumulate in the breastfed infant, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels:
Quazepam has a half-life of about 41 hours and is extensively metabolized to 2-oxoquazepam, which is in turn metabolized to desalkylflurazepam having a half-life of 47 to 100 hours.

Alternate Drugs to Consider:

Quazepam 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.

  • Quazepam is only found in individuals that have used or taken this drug
  • It is a drug which is a benzodiazepine derivative
  • It induces impairment of motor function and has hypnotic properties
  • Quazepam is used to treat insomnia
  • Benzodiazepines bind nonspecifically to benzodiazepine receptors, which affects muscle relaxation, anticonvulsant activity, motor coordination, and memory

Alternate Names:
  • QUAZEPAM
  • DORAL
  • NSC-309702
  • QUAZEPAM CIV
  • SCH-16134
  • DORAL
  • QUAZEPAMUM
  • drugbank:01589
  • pubchem.compound:4999
  • chembl:CHEMBL1200472
  • chemidplus:36735-22-5
  • rxcui:35185

Neiglobal PDF Quazepam

FDA PDF Doral Final Approved Text

Doralrx PDF Doral

  • A relatively long-acting benzodiazepine derivative
  • Developed in the 1970s
  • Patented in 1970 and came into medical use in 1985
  • Indicated for the treatment of insomnia including sleep induction and sleep maintenance

    Quazepam induces impairment of motor function and has relatively (and uniquely) selective hypnotic and anticonvulsant properties with considerably less overdose potential than other benzodiazepines (due to its novel receptor-subtype selectively).

  • Quazepam is an effective hypnotic which induces and maintains sleep without disruption of the sleep architecture
  • Usual dosage is 7.5 to 15 mg orally at bedtime
  • Quazepam causes significantly less drug tolerance and less withdrawal symptoms including less rebound insomnia upon discontinuation compared to other benzodiazepines

    Short-acting hypnotics often cause next day rebound anxiety. Quazepam due to its pharmacological profile does not cause next day rebound withdrawal effects during treatment.

Quazepam is a drug with the potential for misuse. Two types of drug misuse can occur either recreational misuse is where the drug is taken to achieve a high or when the drug is continued long term against medical advice.

  
What should I Know Regarding Pregnancy, Nursing and Administering Quazepam to Children or the Elderly? - management or monitoring precaution: Neuro/Psych-Sedation and fall risk. Long half-life benzodiazepines are generally not preferred in the elderly. If used, limit dose to 7.5mg/day.
Monday April 20, 2015 - webmd.com

Antihistamine Positivity and Involvement in Drug Overdose Deaths - Morbidity and Mortality Weekly Report. 2022;71(41):1308-1310. Nearly 15% of overdose deaths during 2019–2020 were antihistamine-positive, and 4% were antihistamine-involved; only 90 deaths ...
Thursday January 05, 2023 - medscape.com

Mass Spectrometry and Illicit Drug Testing: Analytical Challenges of the Anti-doping Laboratories - Expert Rev Proteomics. 2008;5(4):535-539. A great portion of the analytical methods set up and followed in the anti-doping laboratories rely on mass spectrometric techniques, and especially on the ...
Saturday January 28, 2023 - medscape.com

  
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