temazepam (Rx)

Brand and Other Names:Restoril
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule: Schedule IV

  • 7.5mg
  • 15mg
  • 22.5mg
  • 30mg

Insomnia

15-30 mg PO qHS

Debilitated patients: 7.5 mg PO qHS

Discontinuation: Gradually taper after extended therapy; abrupt discontinuation should be avoided

Safety and efficacy not established

Insomnia

7.5 mg PO qHS; limit use to 10-14 days

Preferred drug in elderly when benzodiazepine indicated because of lack of active metabolite

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Interactions

Interaction Checker

and temazepam

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Drowsiness (9.1%)

            Dizziness (4.5%)

            Lethargy (4.5%)

            Hangover (2.5%)

            Diarrhea (1.7%)

            Euphoria (1.5%)

            Weakness (1.4%)

            Confusion (1.3%)

            Vertigo (1.2%)

            < 1%

            Amnesia

            Angioedema

            Blood dyscrasias

            Sleep-related behavior (eg, sleep driving, sleep cooking, sleep eating)

            Ataxia

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            Warnings

            Black Box Warnings

            Risks from concomitant use with opioids

            • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death
            • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
            • Limit dosages and durations to the minimum required
            • Follow patients for signs and symptoms of respiratory depression and sedation
            • Inform patients and caregivers that potentially fatal additive effects may occur if drug is used with opioids and that such drugs should not be used concomitantly unless supervised by a health care provider
            • Prescribers should advise caregivers that they expect to be informed immediately if a patient develops any new findings which are not typical of the patient’s characteristic seizure episode

            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
            • 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
            • Assess each patient’s risk prior to prescribing and monitor regularly for the development of these conditions
            • 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

            Contraindications

            Documented hypersensitivity

            Acute alcohol intoxication

            Narrow-angle glaucoma (questionable)

            Caution

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

            May impair ability to perform hazardous tasks

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

            Anterograde amnesia may occur

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

            Use in myasthenia gravis is allowed in limited circumstances

            Use caution in severe respiratory depression and depressed neuroses, psychotic reactions

            Paradoxical hyperactive aggressive behavior reported

            Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls

            May cause hyperactive or aggressive behavior

            Use of drug, particularly in patients at elevated risk of abuse, 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: X

            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), possibly by increasing membrane permeability to chloride ions, which in turn increases the inhibitory activity of GABA on neuronal excitability.

            Absorption

            Peak plasma time: 2-3 hr

            Peak plasma concentration: 260-210 ng/mL

            Distribution

            Protein bound: 96%

            Vd: 1.4 L/kg

            Metabolism

            Metabolized by CYP3A4 (minor), glucuronic acid conjugation

            Metabolites: Inactive

            Elimination

            Half-life elimination: 9.5-12.4 hr

            Excretion: Urine (80-90%)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for 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.