Estazolam

Estazolam is used to treat insomnia.

Estazolam is available under the following different brand names: Prosom.

Dosage Forms and Strengths

Tablet: Schedule IV

• 1 mg
• 2 mg

Dosage Considerations – Should be Given as Follows:

Insomnia

• 1-2 mg orally at night

Considerations:

• Hepatic impairment: Use caution; dose adjustment may be necessary
• Geriatric use: initial dose: 0.5 mg orally once/day in small elderly patients; healthy patients may receive 1 mg
• Safety and efficacy not established in pediatric patients
• Drug dependence may occur

Common side effects of Estazolam include:

• Drowsiness
• Headache
• Weakness/lethargy
• Neuromuscular and skeletal weakness
• Dizziness
• Slowed motor function
• Abnormal coordination
• Hangover
• Abnormal thinking
• Flushing
• Palpitations
• Euphoria
• Hostility
• Seizure
• Sleep disorder
• Rash
• Hives

Less common side effects of estazolam include:

• Angioedema
• Sleep-driving (sleep-cooking, sleep eating, etc.)
• Muscle pain or spasm
• Fever
• Neck pain
• Drug dependence

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of estazolam include:
  • itraconazole
  • sodium oxybate
• Serious interactions of estazolam include:
  • benzhydrocodone/acetaminophen
  • fentanyl
  • fentanyl intranasal
  • fentanyl iontophoretic transdermal system
  • fentanyl transdermal
  • fentanyl transmucosal
  • hydrocodone
  • sufentanil SL
  • valerian
• Estazolam has moderate interactions with at least 180 different drugs.
• Mild interactions of estazolam include:
  • brimonidine
  • ciprofloxacin
  • esomeprazole
  • eucalyptus
  • fleroxacin
  • gemifloxacin
  • levofloxacin
  • moxifloxacin
  • ofloxacin
  • omeprazole
  • rifabutin
  • sage
  • vinpocetine
  • zolpidem

Warnings

This medication contains estazolam. Do not take estazolam if you are allergic to estazolam or any ingredients contained in this drug.

Black Box Warnings

Concomitant use of benzodiazepines and opioids may result in profound respiratory depression, coma, and death; administer concomitantly when there are no alternative options; limit dosages and durations to minimum required; monitor for signs and symptoms of respiratory depression and sedation.

Contraindications

• Documented hypersensitivity
• Acute alcohol intoxication
• Myasthenia gravis (allowable in limited circumstances)
• Narrow angle glaucoma (questionable)
• Severe respiratory depression
• Depressed neuroses, psychotic reactions
• Intravenous (IV) use in shock, coma, depressed respiration, patients who recently received other respiratory depressants

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Estazolam?"

Long-Term Effects

• Use caution in patients with history of drug abuse or acute alcoholism; tolerance, psychological and physical dependence may occur with prolonged use
• See "What Are Side Effects Associated with Using Estazolam?"

Cautions

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

Do not use estazolam in pregnancy. The risks involved outweigh potential benefits. Safer alternatives exist.

Minor tranquilizers should be avoided in first trimester of pregnancy due to an 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).

Estazolam enters breast milk. Use of estazolam while breastfeeding is contraindicated.