Classes
DEA Class; Rx
Common Brand Names; ProSom
- Sedative/Hypnotics
Description
Intermediate-acting oral benzodiazepine; no active metabolites.
Used for the short-term treatment of insomnia.
Indications
Indicated for the short-term treatment of insomnia characterized by difficulty in falling asleep, nocturnal awakenings, and/or early morning awakenings.
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
Adverse Effects
- 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
Warnings
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 and Lactation
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)
Maximum Dosage
2 mg/day PO.
2 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Estazolam
tablet: Schedule IV
- 1mg
- 2mg