quazepam (Rx)

Brand and Other Names:Doral
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 7.5mg
  • 15mg

Insomnia

Initial: 15 mg PO qHS

Maintenance: 7.5-15 mg PO qHS

May reduce dose after 1-2 nights

Dosage Modifications

Renal or hepatic impairment: Caution; monitor for signs of overdose like excessive sedation or impaired coordination

Safety and efficacy not established

Caution; use lower dose of 7.5 mg initially

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Interactions

Interaction Checker

and quazepam

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Drowsiness (12%)

            1-10%

            Dizziness

            Xerostomia

            Dyspepsia

            Fatigue

            Headache

            Hangover

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            Warnings

            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
            • Risks of dependence and withdrawal increase with longer treatment duration and higher daily dose; although injection is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions, including seizures, which can be life-threatening; use gradual taper when discontinuing therapy to reduce withdrawal reactions risk
            • Assess each patient’s risk prior to prescribing and monitor regularly for the development of these conditions
            • Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes; before prescribing and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction

            Contraindications

            Documented hypersensitivity

            Acute alcohol intoxication

            Myasthenia gravis (allowable in limited circumstances)

            Narrow angle glaucoma (questionable)

            Severe respiratory depression

            Depressed neuroses, psychotic reactions

            IV use in shock, coma, depressed respiration, patients who recently received other respiratory depressants

            Cautions

            Use caution in COPD, sleep apnea, renal/hepatic disease, impaired gag reflex, respiratory disease, open-angle glaucoma (questionable), depression, suicide ideation

            Anterograde amnesia reported with benzodiazepine use

            May impair ability to perform hazardous tasks

            Patients particularly the elderly, are at higher risk of falls; therapy can cause drowsiness and decrease level of consciousness

            Paradoxical reactions, including yperactive or aggressive behavior reported

            Sleep-related activities, including sleep-driving, cooking and eating, and making phone calls while asleep may occur; discontinue therapy in these patients

            Use caution in patients with history of drug abuse or acute alcoholism; tolerance, psychological and physical dependence may occur with prolonged use

            Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone

            If a decision is made to prescribe a benzodiazepine concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation; in patients already receiving an opioid analgesic, prescribe a lower initial dose than indicated in the absence of an opioid and titrate based on clinical response

            If an opioid is initiated in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid and titrate based upon clinical response

            Use of drug, particularly in patients at elevated risk, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency

            Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate

            For patients using treated more frequently than recommended, to reduce risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose)

            Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use

            In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Avoid if breastfeeding

            Minor tranquilizers should be avoided in 1st trimester of pregnancy due to increased risk of congenital malformations

            Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)

            Prenatal benzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence)

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Depresses all levels of CNS (eg, limbic and reticular formation), by increasing neuronal permeability to chloride ions may increase inhibitory activity of GABA on neuronal excitability

            Pharmacokinetics

            Peak Plasma Time: 2 hr

            Peak plasma concentration: 20 ng/mL

            Half-life elimination: 39 hr (metabolite 73 hr)

            Protein bound: >95%

            Metabolism: Glucuronic acid conjugation

            Metabolites: 2-oxoquazepam, N-desalkyl-2-oxoquazepam

            Excretion: Urine (31%), feces (23%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.