• Short-term management of insomnia.

Contraindicated in:

• Hypersensitivity to estazolam or other benzodiazepines
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Hepatic or renal impairment
• History of depression
• History of drug abuse or suicide attempt.
• Pedi: Safety and effectiveness not established in children
• Geri: ↑risk of cognitive impairment and falls. Initial dose ↓ recommended.

CV: chest pain.

GI: abdominal pain, dyspepsia, nausea.

MS: back pain, lower extremity pain, stiffness.

Neuro: drowsiness, headache, weakness, abnormal dreams, abnormal thinking, behavior changes, confusion, depression, dizziness, hallucinations, hangover, malaise, nervousness, sleep-driving, abnormal coordination, hypokinesia.

Resp: cold symptoms, pharyngitis.

Misc: ANAPHYLAXIS, body pain, physical dependence, psychological dependence.

Drug-Drug:

• Additive CNS depression with alcohol, antihistamines, antidepressants, MAO inhibitors, other sedative/hypnotics (including benzodiazepines), or opioid analgesics.
• Cimetidine or hormonal contraceptives may ↓ metabolism and ↑ effects of estazolam.
• May ↓ efficacy of levodopa.
• Rifampin or cigarette smoking ↑ metabolism and ↓ effectiveness.
• Theophylline may antagonize the effectiveness of estazolam.

Drug-Natural Products:

• Concomitant use of kava, valerian, chamomile, or hops can ↑ CNS depression.
• See sedative interactions.
• St. John's wort may affect estazolam levels and effectiveness; avoid use.

(Generic available)

• Tablets: 1 mg; 2 mg;

• PO (Adults): 1 mg at bedtime; some patients may require 2 mg (range 0.5–2 mg). Debilitated or small elderly patients — may initiate at 0.5 mg, ↑ as needed.

Prosom

• Depresses the CNS, probably by potentiating GABA, an inhibitory neurotransmitter.

• Relief of insomnia.

Therapeutic Classification: sedative/hypnotics

Pharmacologic Classification: benzodiazepines

Absorption: Well absorbed following oral administration.

Distribution: Highly lipid-soluble. Crosses the blood-brain barrier and placenta; enters breast milk.

Protein Binding: 93%.

Metabolism/Excretion: Mostly metabolized by the liver; metabolites do not have CNS depressant activity.

Half-life: 10–24 hr.

Schedule IV (C-IV)

(hypnotic activity)

†Plasma level.

• Advise patient to take medication as directed. Discuss the importance of preparing environment for sleep (dark room, quiet, avoidance of nicotine and caffeine). Gradual discontinuation may be required following prolonged therapy. May cause disturbed sleep for the first 2 nights following discontinuation.
• May cause daytime drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known. Inform patient to notify health care professional if sleep-related behaviors, (may include sleep-driving — driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event) occur.
• Advise patient that estazolam is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
• Caution patients to avoid taking alcohol or other CNS depressants, including opioids, concurrently with this medication.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding.. Monitor infants exposed to estazolam during 2nd and 3rd trimester or immediately prior to or during childbirth for flaccidity and symptoms of withdrawal (hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, vomiting). Inform women who take estazolam during pregnancy about the National Pregnancy Registry for Other Psychiatric Medications to monitor pregnancy outcomes in women exposed to estazolam during pregnancy. Enroll patient by calling 1-866-961-2388 or visiting online at womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.

ess-TAZ-oh-lam

NDC Code^*

• 0591- Actavis Pharma, Inc.
  • 0591-0744- Estazolam
    • 0591-0744-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-0744-01)

• 0591- Actavis Pharma, Inc.
  • 0591-0745- Estazolam
    • 0591-0745-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)

• 51862- Mayne Pharma
  • 51862-069- Estazolam
    • 51862-069-01- 100 TABLET in 1 BOTTLE (51862-069-01)

• 51862- Mayne Pharma
  • 51862-070- Estazolam
    • 51862-070-01- 100 TABLET in 1 BOTTLE (51862-070-01)