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Estazolam

    Brands

    DEA Class;  Rx

    Common Brand Names; ProSom

    • Sedative/Hypnotics

    Intermediate-acting oral benzodiazepine; no active metabolites.
    Used for the short-term treatment of insomnia.

    Indicated for the short-term treatment of insomnia characterized by difficulty in falling asleep, nocturnal awakenings, and/or early morning awakenings.

    For the treatment of insomnia in adults with generalized anxiety disorder (GAD).

    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

    • Somnolence (42%)
    • Headache (16%)
    • Asthenia (11%)
    • Neuromuscular & skeletal weakness
    • Dizziness (7-8%)
    • Hypokinesia (7-8%)
    • Abnormal coordination (4%)
    • Hangover (3%)
    • Abnormal thinking (2%)
    • Flushing palpitation
    • Hangover effect
    • Euphoria
    • Hostility
    • Seizure
    • Sleep disorder
    • Rash
    • Urticaria
    • Angioedema
    • Sleep-driving (sleep-cooking, sleep eating, etc) may occur
    • Muscle spasm
    • Fever
    • Neck pain
    • Myalgia
    • Drug dependence may occur

    Use caution in respiratory diseases, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), impaired gag reflex, clinical depression, suicide ideation, patients receiving other CNS depressants concurrently

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

    Anterograde amnesia

    May cause CNS depression that impairs mental and physical abilities

    Hyperactive or aggressive behavior may occur

    May impair ability to perform hazardous tasks

    Pregnancy Category: X

    Lactation: Enters breast milk/contraindicated

    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)

    Adults

    2 mg/day PO.

    Elderly

    2 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Estazolam

    tablet: Schedule IV

    • 1mg
    • 2mg