Estazolam

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

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