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Pronunciation:

(KWAY ze pam)

U.S. Brand Names:

Doral®

Generic Available:

Canadian Brand Names:

Doral®

Use:

Treatment of insomnia

Restrictions:

C-IV

Pregnancy Risk Factor:

Lactation:

Enters breast milk/not recommended (AAP rates "of concern")

Contraindications:

Hypersensitivity to quazepam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist); narrow-angle glaucoma (not in product labeling, however, benzodiazepines are contraindicated); pregnancy

Warnings/Precautions:

Should be used only after evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric or medical illness. A worsening of insomnia or the emergence of new abnormalities of thought or behavior may represent unrecognized psychiatric or medical illness and requires immediate and careful evaluation. Use with caution in elderly or debilitated patients, patients with hepatic disease (including alcoholics), or renal impairment. Use with caution in patients with respiratory disease or impaired gag reflex. Avoid use in patients with sleep apnea.

Causes CNS depression (dose-related) resulting in sedation, dizziness, confusion, or ataxia which may impair physical and mental capabilities. Patients must be cautioned about performing tasks which require mental alertness (operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated. Benzodiazepines have been associated with falls and traumatic injury and should be used with extreme caution in patients who are at risk of these events (especially the elderly).

Use caution in patients with depression, particularly if suicidal risk may be present. Use with caution in patients with a history of drug dependence. Benzodiazepines have been associated with dependence and acute withdrawal symptoms on discontinuation or reduction in dose. Acute withdrawal, including seizures, may be precipitated after administration of flumazenil to patients receiving long-term benzodiazepine therapy.

Benzodiazepines have been associated with anterograde amnesia. Paradoxical reactions, including hyperactive or aggressive behavior have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Does not have analgesic, antidepressant, or antipsychotic properties.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Palpitations

Central nervous system: Drowsiness, fatigue, ataxia, memory impairment, anxiety, depression, headache, confusion, nervousness, dizziness, incoordination, hypo- and hyperkinesia, agitation, euphoria, paranoid reaction, nightmares, abnormal thinking

Dermatologic: Dermatitis, pruritus, rash

Endocrine & metabolic: Decreased libido, menstrual irregularities

Gastrointestinal: Xerostomia, constipation, diarrhea, dyspepsia, anorexia, abnormal taste perception, nausea, vomiting, increased or decreased appetite, abdominal pain

Genitourinary: Impotence, incontinence

Hematologic: Blood dyscrasias

Neuromuscular & skeletal: Dysarthria, rigidity, tremor, muscle cramps, reflex slowing

Ocular: Blurred vision

Miscellaneous: Drug dependence

Drug Interactions:

Substrate of CYP3A4 (minor)

CNS depressants: Sedative effects and/or respiratory depression may be additive with CNS depressants; includes ethanol, barbiturates, narcotic analgesics, and other sedative agents; monitor for increased effect

Levodopa: Therapeutic effects may be diminished in some patients following the addition of a benzodiazepine; limited/inconsistent data

Oral contraceptives: May decrease the clearance of some benzodiazepines (those which undergo oxidative metabolism); monitor for increased benzodiazepine effect

Theophylline: May partially antagonize some of the effects of benzodiazepines; monitor for decreased response; may require higher doses for sedation

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Mechanism of Action:

Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization.

Pharmacodynamics/Kinetics:

Absorption: Rapid

Protein binding: 95%

Half-life elimination, serum: Parent drug: 25-41 hours; Active metabolite: 40-114 hours

Dosage:

Adults: Oral: Initial: 15 mg at bedtime, in some patients the dose may be reduced to 7.5 mg after a few nights

Elderly: Dosing should be cautious; begin at lower end of dosing range (ie, 7.5 mg)

Dosing adjustment in hepatic impairment: Dose reduction may be necessary

Monitoring Parameters:

Respiratory and cardiovascular status

Patient Education:

Avoid alcohol and other CNS depressants; avoid activities needing good psychomotor coordination until CNS effects are known; drug may cause physical or psychological dependence; avoid abrupt discontinuation after prolonged use

Nursing Implications:

Provide safety measures (ie, side rails, night light, call button); remove smoking materials from area; supervise ambulation

Monitor respiratory and cardiovascular status

Additional Information:

More likely than short-acting benzodiazepine to cause daytime sedation and fatigue; is classified as a long-acting benzodiazepine hypnotic (eg, flurazepam), this long duration of action may prevent withdrawal symptoms when therapy is discontinued. Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms.

Anesthesia and Critical Care Concerns/Other Considerations:

Quazepam is more likely than short-acting benzodiazepine to cause daytime sedation and fatigue. It is classified as a long-acting benzodiazepine hypnotic (like flurazepam - Dalmane®); this long duration of action may prevent withdrawal symptoms when therapy is discontinued. Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Tablet: 7.5 mg, 15 mg

International Brand Names:

Doral® (CA); Dormé® (ZA); Quazium® (IT); Quiedorm® (ES)

References

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,"Pediatrics, 2001, 108(3):776-89.

Chung M, Hilbert JM, Gural RP, et al, "Multiple Dose Quazepam Kinetics,"Clin Pharmacol Ther, 1984, 35(4):520-4.

Hilbert JM, Gural RP, Symchowicz S, et al, "Excretion of Quazepam Into Human Breast Milk,"J Clin Pharmacol, 1984, 24(10):457-62.

Martinez HT and Serna CT, "Short-Term Treatment With Quazepam of Insomnia in Geriatric Patients,"Clin Ther, 1982, 5(2):174-8.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922.

Winsauer HJ and O'Hair DE, "Quazepam: Short-Term Treatment of Insomnia in Geriatric Outpatients,"Curr Ther Res, 1984, 35(2):228-34.

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