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estazolam

Adjunctive therapy

Brand: PROSOM

Published 2026-02-16 · Last reviewed 2026-02-23 · 5 references

Content sourced from FDA labeling (DailyMed) and peer-reviewed literature.

Print sheet Review evidence

At a glance

Class: Adjunctive therapy·Typical dose: Adults: recommended initial dose is 1 mg at bedtime; some may need 2 mg (label).·Half-life: Single-dose range 10–24 h·LAI available: No

Class: Adjunctive therapy
Typical dose: Adults: recommended initial dose is 1 mg at bedtime; some may need 2 mg (label).
Half-life: Single-dose range 10–24 h
LAI available: No

Quick answers

What is estazolam?: Estazolam (brand ProSom) is a benzodiazepine hypnotic indicated for the short-term treatment of insomnia (label; product-dependent). It can improve sleep onset and maintenance, but dependence, withdrawal, and next-day impairment make it a poor default long-term strategy.
What is PROSOM?: PROSOM is a brand name for estazolam.
What is PROSOM (estazolam) used for?: Label indications include: Short-term treatment of insomnia (label; product-dependent).
What drug class is PROSOM (estazolam)?: Benzodiazepine.
What is the mechanism of action of PROSOM (estazolam)?: Benzodiazepine hypnotic; GABA-A receptor positive allosteric modulator.
What strengths does PROSOM (estazolam) come in?: Scored tablets: 1 mg, 2 mg.

General information

Estazolam is a benzodiazepine hypnotic indicated for the short-term treatment of insomnia (label; product-dependent). It can improve sleep onset and maintenance but is not a maintenance strategy for chronic insomnia.

Estazolam’s elimination half-life is relatively long for a hypnotic (10–24 hours; longer in some older adults). Longer duration can reduce late-night rebound but increases morning grogginess, falls, and impaired driving risk—especially with polypharmacy (label).

Benzodiazepine risks extend beyond sedation: abuse, misuse, addiction, and withdrawal reactions are core safety constraints and support a time-limited plan with a defined reassessment date (label / safety guidance).

Boxed warning: Concomitant use with opioids can cause profound sedation, respiratory depression, coma, and death; avoid co-prescribing when possible (label).

The estazolam compare view, estazolam evidence feed, and estazolam print page can support shared decision-making and safe-use counseling.

U.S. approvals

Insomnia (short-term)

Formulations & strengths

Scored tablets: 1 mg, 2 mg.

Generic availability

Widely available generically; ProSom is a recognizable legacy brand name.

Estazolam is often positioned as an “intermediate-to-long” benzodiazepine hypnotic: it can cover sleep maintenance but has meaningful carryover impairment risk. It is typically paired with a brief course, a follow-up date, and an exit/taper plan, with preference for CBT-I and non-controlled options when insomnia is chronic.

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Mechanism of action

Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.

Positive allosteric modulator of GABA-A receptors, increasing inhibitory neurotransmission and producing hypnotic effects.

Sedation and cognitive slowing scale with dose and co-administered CNS depressants; total sedative burden is a major driver of harm.

Repeated nightly use can lead to tolerance and physical dependence; abrupt discontinuation can cause rebound insomnia and withdrawal.

GABA-A receptor positive allosteric modulation.

Metabolism & pharmacokinetics

Mean elimination half-life estimates range from 10–24 hours; in a small older-adult study, mean half-life was 18.4 hours (range 13.5–34.6 hours) (label).
Hepatic metabolism to hydroxylated metabolites; biotransformation to 4-hydroxy-estazolam is mediated by CYP3A (label).
After 5 days, 87% of radiolabeled drug was recovered in urine, primarily as metabolites; <5% is excreted unchanged in urine and ~4% in feces (label).
Longer half-life increases the risk of next-day impairment and interactions with other psychoactive medications and alcohol (label / class).

Dosing & administration

Adults: recommended initial dose is 1 mg at bedtime; some may need 2 mg (label).
Older adults: 1 mg is a typical starting dose, but dose increases are approached cautiously; in small or debilitated older adults, 0.5 mg is sometimes used to reduce falls and confusion (label).
Use the lowest effective dose and take only when a full sleep window is possible; avoid middle-of-the-night “catch-up” dosing.
If used beyond a short course, tapering is commonly used to reduce rebound insomnia and withdrawal symptoms (label / class).

Monitoring & labs

Reassess benefit and adverse effects within 1–2 weeks; discontinue if benefit is marginal or impairment emerges.
Screen for opioid co-prescribing, alcohol use, untreated sleep apnea, and fall risk before renewing.
Review the medication list for CYP3A inhibitors and additive sedatives before initiation and dose changes.
If used beyond a short course, create a taper plan and monitor for rebound insomnia and withdrawal symptoms.

Sources: FDA/DailyMed label; insomnia guideline context; benzodiazepine safety guidance.

Adverse effects

FDA boxed warnings

Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death.

Common side effects (≥10%)

Sedation / next-day impairment: Assess driving risk, fall risk, and daytime functioning; higher risk with long half-life.
Dizziness / ataxia: More problematic in older adults and with polypharmacy.
Cognitive impairment / anterograde amnesia: May present as confusion, memory gaps, or disinhibited behavior.
Rebound insomnia: More likely after repeated nightly use or abrupt discontinuation.
Paradoxical agitation: If agitation or behavioral changes appear, reassess and discontinue rather than escalating dose.

Other notable effects

Dependence and withdrawal reactions (including seizures in severe cases) can occur after prolonged use; gradual tapers reduce risk.
Respiratory depression risk increases with alcohol, opioids, untreated sleep apnea/COPD, and other sedatives.
Falls and fractures can occur when morning impairment is present, especially in older adults.

Interactions

CYP3A inhibitors can increase estazolam exposure and adverse effects; review interacting antibiotics/antifungals and antiviral regimens (label).
Additive CNS/respiratory depression occurs with alcohol, opioids, antihistamines, and sedating antipsychotics; avoid stacking sedatives when possible.
Grapefruit products and other moderate CYP3A inhibitors can increase exposure; dose reduction or switching hypnotics is commonly considered if carryover impairment emerges.

Other useful information

When insomnia is chronic, guidelines typically prioritize CBT-I and treat underlying contributors (mood episodes, pain, substance use, sleep apnea) rather than escalating hypnotic intensity.
A time-limited plan often includes documentation of indication, intended duration, quantity limits, and a taper strategy if nightly use persists.
If next-day impairment is prominent, clinicians often pivot to shorter acting or non-controlled options rather than increasing dose.

References

Related hubs:SMI toolkit·Support resources