Estazolam
Estazolam is a benzodiazepine sleep medicine used for the short-term management of insomnia.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Estazolam carries three serious, FDA-required warnings that all patients must be aware of before starting this medicine.
1. Risk with opioids: Taking estazolam at the same time as opioid pain or cough medicines (such as codeine, oxycodone, or hydrocodone) can cause extreme drowsiness, dangerously slow breathing, coma, or death. This combination should only happen if there is no other option, and only under close medical supervision.
2. Abuse, misuse, and addiction: Estazolam is a controlled substance. It can be misused or lead to addiction, which can result in overdose or death — especially when combined with other drugs, alcohol, or illicit substances.
3. Dependence and withdrawal: Regular use can cause your body to become physically dependent on estazolam. Stopping suddenly or cutting the dose too fast can trigger severe withdrawal reactions — including life-threatening seizures. Always work with your doctor to taper off slowly.
📖 Estazolam: Patient Information Guide
A plain-language walkthrough of Estazolam — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Estazolam is a benzodiazepine sleep medicine approved for short-term use in adults with insomnia. Supported uses include:
- Trouble falling asleep at the start of the night
- Waking up frequently during the night
- Waking up too early in the morning and being unable to fall back asleep
Estazolam is not intended for long-term use. If sleep problems persist beyond 7–10 days of treatment, a doctor should look for an underlying cause.
⚙️How it works▾
Estazolam belongs to the benzodiazepine class of medicines. It works by boosting the activity of GABA — a naturally occurring brain chemical that slows down nerve activity. By enhancing GABA's calming effect, estazolam makes it easier to fall asleep and stay asleep through the night. The drug's sleep-inducing effect comes primarily from the parent compound itself, not its breakdown products.
One thing worth knowing: if estazolam is used nightly for an extended period, the body can develop some tolerance to its effects — and since it stays in the system for 10–24 hours, next-day drowsiness or grogginess is possible.
💊How it's taken▾
Estazolam tablets are taken by mouth once at bedtime. They can be taken with or without food. Your prescriber will choose the right starting dose for you — older adults and smaller or frail patients are typically started at a lower dose, with any increases made carefully.
- Take only at bedtime, when you have enough time to sleep
- Do not take more than your prescriber directs
- Never stop estazolam suddenly — always taper off gradually under your doctor's guidance to avoid withdrawal
- Follow your pharmacist's label and your prescriber's instructions for your specific dose and schedule
🤒Side effects — in detail▾
The most common side effects reported with estazolam include:
- Drowsiness or sleepiness (the most frequently reported effect)
- Slowed or sluggish movements (hypokinesia)
- Dizziness
- Poor coordination
- Morning grogginess or hangover feeling
- Weakness or fatigue
- Headache
- Confusion
More serious reactions — such as complex sleep behaviors (like sleep-driving), allergic swelling of the throat or tongue, memory problems, or unusual behavioral changes like agitation or hallucinations — require immediate medical attention. Slow or difficult breathing, especially if combined with opioids or alcohol, is a medical emergency.
⚠️Warnings & precautions▾
- Opioid combination risk: Using estazolam with opioid pain medicines can cause life-threatening breathing problems, coma, or death. Avoid this combination whenever possible.
- Dependence and withdrawal: Regular use leads to physical dependence. Stopping suddenly can trigger severe withdrawal reactions, including seizures. Always taper off slowly with medical guidance.
- Abuse and addiction: Estazolam has real potential for misuse and addiction, particularly when used with alcohol or other substances.
- Complex sleep behaviors: Some people have driven, cooked, made phone calls, or had sex while asleep — with no memory afterward. If this happens, contact your doctor immediately.
- Falls risk: Estazolam can impair balance and coordination, especially in older adults. Take care when getting up at night.
- Allergic reactions: Rare but serious swelling of the tongue, throat, or airway has been reported. Seek emergency care immediately if this occurs.
- Daytime impairment: Do not drive or operate heavy machinery until you know how estazolam affects you — including the day after you take it.
🔀What it interacts with▾
Estazolam can interact with several medications and substances, sometimes dangerously:
- Opioid pain medicines (e.g., oxycodone, codeine, morphine) — combined use dramatically increases the risk of slow breathing, coma, and death
- Alcohol — makes sedation much stronger and raises the risk of dangerous breathing problems
- Ketoconazole and itraconazole (antifungal medicines) — contraindicated; these drugs block the enzyme that breaks down estazolam, causing unsafe build-up
- Nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazid, and some macrolide antibiotics — may increase estazolam levels; use with caution
- Carbamazepine, phenytoin, rifampin, and barbiturates — may reduce estazolam levels, making it less effective
- Other CNS depressants (antihistamines, antipsychotics, other sleep aids, muscle relaxants, antiseizure drugs) — can intensify sedation
- Cigarette smoking — speeds up the liver's breakdown of estazolam, potentially reducing its effect
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your prescriber if you take any opioid pain or cough medicines — this is a high-risk combination
- Do not take estazolam if you are also taking ketoconazole or itraconazole (antifungal medicines) — this is contraindicated
- Older adults: use extra caution — you may be more sensitive to side effects and at higher risk of falls
- Tell your doctor if you are pregnant or thinking about becoming pregnant — use late in pregnancy can sedate the newborn or cause withdrawal in the baby after birth
- Tell your doctor if you have liver or kidney problems — how estazolam is processed may be affected
- Tell your doctor if you have a personal or family history of substance use disorder or addiction
- Estazolam has not been studied in children; it is not approved for pediatric use
- Tell your doctor if you smoke — this affects how quickly your body clears the medicine
🚑If you take too much▾
Taking too much estazolam — or combining it with opioids, alcohol, or other sedatives — can cause extreme drowsiness, confusion, slurred speech, loss of coordination, slowed breathing, and in severe cases, coma. Overdose involving multiple substances can be fatal. If you suspect an overdose, call 911 or your local poison control center (1-800-222-1222) immediately.
📡Pharmacodynamics — effects in the body▾
Estazolam slows down brain activity by enhancing GABA, the brain's main calming chemical, which helps with both falling asleep and staying asleep. Because it stays in the body for 10–24 hours, some sedative effects may carry over into the next day — leading to drowsiness or impaired coordination during waking hours. With nightly use over time, the body may develop some tolerance (reduced response) to its sleep effects. If estazolam is stopped abruptly, a rebound in wakefulness or anxiety can occur.
🔬Pharmacokinetics — how your body processes it▾
After taking estazolam by mouth, peak blood levels are typically reached within two hours (though this can range from 30 minutes to 6 hours). The drug is about 93% bound to proteins in the bloodstream. It is extensively broken down by the liver — mainly through an enzyme called CYP3A — and most of the breakdown products leave the body through the urine. The half-life (the time it takes for half the drug to be cleared from the body) ranges from about 10 to 24 hours in younger adults, and may be somewhat longer in older adults. Cigarette smoking speeds up the body's clearance of estazolam.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
📄 Written from Estazolam’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Estazolam
99 supplements and herbal products have documented interactions with Estazolam in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 76
- Minor · 15
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Estazolam — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is estazolam used for? ▾
How should I take estazolam — does it matter when or if I eat first? ▾
What side effects should I expect, and which ones should I call my doctor about? ▾
I also take a pain medicine that contains an opioid. Is it safe to take estazolam too? ▾
Can I become dependent on estazolam, and what happens if I stop taking it? ▾
Are there any medications or drinks I need to avoid while taking estazolam? ▾
Is Estazolam available over the counter? ▾
Is Estazolam a controlled substance? ▾
When was Estazolam first available? ▾
Who makes Estazolam? ▾
💬 Answers drafted from Estazolam’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Estazolam comes
Estazolam is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Estazolam tablets are used for the short-term management of insomnia, including difficulty falling asleep, frequent nighttime awakenings, and early morning awakening.
- Estazolam tablets are taken by mouth at bedtime.
- Estazolam tablets may be taken with or without food.
- Estazolam is intended for short-term use; do not take it longer than your prescriber directs.
- Estazolam should never be stopped abruptly — follow your doctor's plan to reduce the dose gradually to avoid withdrawal.
📊 Estazolam across the U.S. market
How Estazolam appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Estazolam is used
A general measure of how commonly Estazolam is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Estazolam is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Estazolam prescribed? Of the 1,597 medications we measure, Estazolam ranks #1,334 by Medicaid prescriptions — more than 16% of them.
Utilization by Estazolam product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
estazolam 2 MG Oral Tablet Most dispensed
Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197654
estazolam 1 MG Oral Tablet
Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197653
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Estazolam, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 13 listed Estazolam NDCs with Medicaid activity.
🔍 Compare Estazolam products
A representative set of FDA-listed product records for Estazolam — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 1 mg | — | Actavis Pharma, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 mg | Oral | Actavis Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 2 mg | Oral | Actavis Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 2 mg | — | Actavis Pharma, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 mg | Oral | Dr. Reddy's Labratories Inc. | ANDA | View NDC → |
| 2 mg | Oral | Dr. Reddy's Labratories Inc. | ANDA | View NDC → |
| 1 mg | Oral | Mayne Pharma × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Mayne Pharma × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Novitium Pharma LLC | ANDA | View NDC → |
| 2 mg | Oral | Novitium Pharma LLC | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Cambrex Profarmaco Milano Srl | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | F.i.s. Fabbrica Italiana Sintetici S.p.a. | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited | BULK INGREDIENT | View NDC → |
Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Estazolam NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Estazolam — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Estazolam in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Estazolam went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4077 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 372071In current FDA listings
Look up RxCUI 4077 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Estazolam is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Estazolam belongs to the Benzodiazepine class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Dr. Reddy's Labratories Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.