Medication approval journey

lorazepam (Ativan)

Approved for Anxiety disorders; short-term relief of anxiety symptoms

Also answers to “the hospital corners” — its codename in our videos and posts. The full codebook

FDA approvedBenzodiazepineTaper risk: high

How this page reads

The page as written, with the clinical terms

Plain language uses the same facts, the same numbers and the same caveats. It does not leave anything out. Quotes from the FDA label are never reworded in either setting.

Before you stop or change your lorazepam dose

Stopping abruptly can be dangerous — never do it without medical supervision

Do not stop a benzodiazepine abruptly. Abrupt withdrawal can cause seizures, delirium, and can be fatal. Physical dependence develops within weeks of daily use and is not the same thing as addiction. Coming off safely is a prescriber-supervised taper measured in months, sometimes far longer, and going slower is not failure.

How long the lorazepam trials actually ran

We could not establish a longest trial length for lorazepam. That is a gap in what we can show you — not evidence that the trials ran long.

Approved before the Physician Labeling Rule, so no clinical studies section was ever required. The absence is the state of the public record, not a gap in our research.

The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.

People often stay on these drugs for far longer than the trials ran. The label does not say how long any trial ran.

That does not mean longer use is unsafe. It does not mean the drug stops working either. It means longer use was never the thing that got tested.

If you have been on it a long time, that is a fair thing to ask your prescriber about.

Boxed warning: risks from use with opioids

The strongest warning the FDA puts on a label, often called a black box warning. It is reproduced below word for word, not summarised.

This is the strongest warning the FDA can put on a drug label. Some people call it a black box warning. We copied it word for word. We did not shorten it and we did not soften it.

The lorazepam boxed warning covers risks from use with opioids; abuse, misuse, and addiction; dependence and withdrawal reactions.

The warning below covers three things. First, taking this drug with an opioid can cause deep sedation, slowed breathing, coma, and death. Second, it can be abused and misused. That can lead to addiction, overdose, and death. Third, taking it day after day can lead to physical dependence. Stopping fast after that can set off withdrawal. The label says that withdrawal can be life threatening, so it says to come off slowly.

The FDA’s own words follow, copied exactly.

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including lorazepam tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing lorazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including lorazepam tablets may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of lorazepam tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage ( DOSAGE AND ADMINISTRATION and WARNINGS ).

FDA label effective August 7, 2026 — read the full label on DailyMed

What lorazepam is FDA approved for, and what the record shows

Approved for the management of anxiety disorders or the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms in 1977, under application NDA 017794. Source: FDA Drugs@FDA.

The FDA has never published its original 1977 review of lorazepam — Drugs@FDA carries review documents mainly for approvals from the late 1990s onward — and the marketed oral label has no clinical studies section. So the number of pivotal efficacy trials, their durations, comparators, and individual results are not public. What follows is everything the label itself states about the clinical record.

The label's only trial-scale figure is a side-effect sample of about 3,500 patients treated for anxiety. It also states that the effectiveness of lorazepam in long-term use — more than 4 months — has not been assessed by systematic clinical studies.

A large gap first. The FDA has never published its 1977 review of this drug. Drugs@FDA holds review papers mostly for approvals from the late 1990s on.

The label sold today has no clinical studies section. So the number of trials is not public. Nor is how long they ran, what they were compared with, or how each came out. What follows is everything the label says about the trial record.

The FDA approved lorazepam in 1977. The approved use was managing anxiety disorders. It also covers short-term relief of anxiety symptoms. That includes anxiety that comes with low mood. The file number is NDA 017794. The source is Drugs@FDA, the FDA's own database.

The only trial-scale figure on the label is a side effect sample. It covers about 3,500 people treated for anxiety.

The label also says that use beyond 4 months has not been looked at in planned studies.

Participants
About 3,500 patients in the anxiety sample
The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Verbatim from the lorazepam FDA label, Indications and Usage section, effective August 7, 2026 — read the full label on DailyMed.

Side effects of lorazepam listed on the FDA label

Incidence in a sample of about 3,500 patients treated for anxiety, reported on the label without a placebo comparison or stated trial durations; the label adds that the incidence of sedation and unsteadiness increased with age. Its many other listed reactions carry no rates, so only the four quantified ones appear here.

Read the limits first. These numbers come from a sample of about 3,500 people treated for anxiety. The label gives no placebo group to compare against. It does not say how long they were treated.

It adds that sedation and unsteadiness went up with age. Most of the other effects it lists carry no rates. So only the four with numbers appear here.

  • Sedation (15.9%)
  • Dizziness (6.9%)
  • Weakness (4.2%)
  • Unsteadiness (3.4%)
In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

From the lorazepam FDA label, Adverse Reactions section, effective August 7, 2026 — DailyMed.

More from the lorazepam label: drug abuse and dependence

  • Schedule IV controlled substance

    Lorazepam is a Schedule IV controlled substance. The label describes it as a benzodiazepine and CNS depressant with a potential for abuse and addiction, and notes that even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse.

    FDA label, Drug Abuse and Dependence section.

  • Dependence, tolerance, and tapering

    Continued therapy may produce physical dependence and tolerance; the risk of withdrawal reactions is greater at higher dosages and with longer use. The label directs a gradual taper for discontinuation or dose reduction, because abrupt discontinuation or rapid dose reduction can precipitate acute withdrawal reactions, including life-threatening seizures.

    FDA label, Drug Abuse and Dependence section.

  • Protracted withdrawal syndrome

    The label describes a protracted withdrawal syndrome with benzodiazepines — anxiety, cognitive impairment, depression, insomnia, paresthesia, and other symptoms persisting beyond 4 to 6 weeks after initial withdrawal and sometimes lasting more than 12 months — which can be hard to distinguish from a return of the symptoms the drug was treating.

    FDA label, Drug Abuse and Dependence section.

How many Americans take lorazepam

Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.

These are federal survey numbers. They come out about two years late. They count prescriptions filled. They do not tell you if the drug helped.

9,095,808
prescriptions in the United States (2024), refills included
2,178,410
people filling them (2024), ± 459,371 (95%)

Prescriptions are down 43% from 2014 to 2024, a change larger than the survey’s margin of error. Whatever you decide about lorazepam, you are deciding alongside about 2,178,410 other people in 2024.

Prescriptions by year: 2014 15,947,170 · 2015 15,698,434 · 2016 14,317,317 · 2017 12,359,439 · 2018 13,222,989 · 2019 10,875,212 · 2020 10,559,374 · 2021 8,860,599 · 2022 8,502,480 · 2023 6,963,900 · 2024 9,095,808.

Prescriptions are down 43 percent since 2014. About 2.2 million people in the United States took it in 2024.

Correction (29 September 2026). An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves.

Source: AHRQ Medical Expenditure Panel Survey (MEPS), Prescribed Medicines public-use files, 2014 (HC-168A) through 2024 (HC-254A), computed by veisund. People with at least one purchase where the Multum generic name (RXDRGNAM) equals the drug, weighted by the year’s person weight; purchases include refills. Standard errors by Taylor linearization on VARSTR/VARPSU. AHRQ’s reliability rule: a year is not shown when fewer than 60 survey respondents reported the drug or the relative standard error is over 50%. AHRQ cautions that its 2018 questionnaire redesign and the 2020–2022 pandemic years make year-to-year comparisons less certain.

What people report to the FDA about lorazepam

Read this before the numbers.

Anyone can file an adverse event report — patients, doctors, manufacturers — and nobody verifies that the drug caused what was reported. There is no denominator: tens of millions of prescriptions generate reports at an unknowable rate, and reporting rises with news coverage, not necessarily with harm. Counts below are report volumes, not rates, and cannot be compared between drugs. The FDA itself says not to use this data to make medical decisions — we show it because you deserve to see what is in the public record, with its limits stated plainly.

Read this before the numbers.

Anyone can send a report to the FDA. Patients can. Doctors can. Drug makers can. Nobody checks that the drug caused what the report describes.

There is also no bottom number. Tens of millions of prescriptions turn into reports at a rate nobody knows. Reports go up when a drug is in the news, and that is not the same as more harm.

So these are counts of reports. They are not rates. You cannot use them to compare one drug with another. The FDA itself says not to use this data to make medical choices.

We show it because it is on the public record, and you should get to see it with its limits named.

178,727
reports mentioning lorazepam, all time
137,468
filed as serious (a report-level flag covering every drug and outcome in the report)
filed as serious. That flag covers the whole report, and one report can name more than one drug and more than one outcome.

Most-reported reactions

  • Fatigue13,822
  • Nausea13,647
  • Drug ineffective12,491
  • Diarrhoea10,647
  • Off label use10,585
  • Dyspnoea9,489
  • Anxiety9,034
  • Headache8,908
  • Pain8,868
  • Vomiting8,797

“Drug ineffective” ranking this high is worth noticing: a report of not being helped counts as an adverse event too, and people file them in large numbers.

It is worth noticing how high “drug ineffective” ranks. A report that the drug did not help counts as an adverse event too. People file a lot of them.

Source: FDA Adverse Event Reporting System (FAERS), via openFDA, openFDA dataset refreshed 2026-07-30 (the refresh date of the query endpoint, not the date reports run through).

Drug interactions listed on the lorazepam label

The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.

Below is the part of the FDA label that lists other drugs. It is copied word for word.

No list on the web can see what else you take. A pharmacist can. Ask one to check your full list.

Read the label’s interactions section

Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. The benzodiazepines, including lorazepam, produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics. Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest. Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate. Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid. The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation. Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

FDA label for lorazepam, effective August 7, 2026 — DailyMed.

Label history: when this label changes, it is recorded in What changed.

Who pays for lorazepam

Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.

Medicare Part D · claims · 2024Medicaid · claims floor · 2024All-payer · survey · 2024Commercially insured adults · not publishedChildren · no per-drug data
Medicare Part D
Read the under-65 group correctly before the numbers: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error. The beneficiary total sums brand-level rows, so treat it as an upper bound on distinct people. 1,882,975 beneficiaries filled 8,137,337 claims in 2024 — 1,561,790 aged 65 and over, and 321,185 under 65.
Medicaid
At least 1,265,963 prescriptions in 2024 — a floor, because 156 of 669 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.
All payers (survey estimate)
A survey estimate from 140 respondents, which we computed from AHRQ’s MEPS 2024 Prescribed Medicines file (people with at least one purchase, weighted; purchases include refills), puts the whole country at 9,095,808 purchases and 2,178,410 people in 2024. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.
The population nobody counts
The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of lorazepam specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.

Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.

Who has been paying for lorazepam, 2019–2024

Medicare Part D

Claims, all ages — the one payer with a public per-drug series.

20192024

9,162,021 → 8,137,337 claims

Medicare under 65

Beneficiaries, not ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population. A gap is a suppressed split, not zero.

20192024

420,347 → 321,185 beneficiaries

Medicaid

A floor each year — small-cell rows are suppressed federally and excluded from the sum.

20192024

1,538,495 → 1,265,963 prescriptions (floor)

Commercially insured adults

No public dataset publishes per-drug commercial claims for any year — the absence is the finding, and it is rendered, not interpolated. The population this library most wants to inform is the one with no public per-drug series, in any year — insurers and PBMs hold that data privately. What the federal surveys do measure — how many adults take these medications at all — is on the adult-usage page.

Sources: Medicare Part D Prescribers by Geography and Drug (data.cms.gov, national rows, per data year); Medicaid State Drug Utilization Data (data.medicaid.gov, national rows). Claims, fills and beneficiaries are different units — compare each series only with itself.

The lorazepam approval, step by step

  1. Step 1

    What the approval was actually based on

    Which studies did the FDA rely on, how long did they run, and who was in them?

    read the label on DailyMed

    Our reading

    Approved in 1977 under the old label format, and the current label still carries no clinical studies section — the trials the approval rested on are in FDA archives, not on the document your pharmacist can print. That absence is the state of the record, not a gap in our research. What the label does carry, prominently, is the benzodiazepine class boxed warning about dependence, withdrawal, and combination with opioids — added in 2020, forty-three years after approval. The label also states that the effectiveness of lorazepam in long-term use, beyond four months, has not been assessed by systematic clinical studies.

  2. Step 2

    The approval

    When was it approved, under what application, and by whose review?

    Approved
    September 30, 1977
    Application
    NDA017794
    Review
    STANDARD
    Original sponsor
    Wyeth
    Holds it now
    Bausch Health
    Label submissions since
    29

    Source: openFDA Drugs@FDA, original application ORIG-1

  3. Step 3

    What was added after it was on the market

    Which warnings arrived only after millions of people were already taking it?

    • The FDA strengthened the benzodiazepine warning in 2020

      43 years after approval

      In September 2020 the FDA required the boxed warning on every benzodiazepine to be rewritten. The wording matters: physical dependence can develop even when the medication is taken exactly as prescribed, and stopping abruptly or dropping the dose quickly can cause withdrawal reactions that include seizures and can be life-threatening.

      This is not a claim that the medication is bad or that you should stop taking it. It is the opposite. It is the reason not to stop on your own. The FDA's own instruction to prescribers is to taper gradually rather than stop, and to reassess dose and duration over time.

      Worth asking

      How long is the plan for me to be on this, what does my taper look like if we decide to come off, and how will we tell withdrawal apart from my original anxiety coming back.

      FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class — U.S. Food and Drug Administration (2020)

    • The lorazepam label lists alcohol, antidepressants and antipsychotics together as drugs that add to its sedation

      48 years after approval

      "Can I have a drink on this" is the most common interaction question, and the lorazepam label answers it in one list that also includes the other psychiatric drugs a person is likely to be on.

      Significant findings

      ATIVAN prescribing information (Bausch Health, November 2025), Drug Interactions: "The benzodiazepines, including Ativan (lorazepam), produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics."

      The boxed warning is the same as every benzodiazepine's: "Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death," and "Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes."

      The mechanism sentence: "The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration." And a dosing instruction for the combination: "In patients already receiving an opioid analgesic, prescribe a lower initial dose of Ativan than indicated in the absence of an opioid".

      Worth asking

      Alcohol on this list is not a moral point; it is pharmacology. Alcohol and benzodiazepines act on the same receptor, so one drink on lorazepam is not one drink. The antidepressants and antipsychotics on the same list are the reason a person on several psychiatric drugs may be far more sedated by a small amount of alcohol than they expect. If you drink, the question for the prescriber is how much your particular combination changes the effect of one drink, and whether driving the next morning is affected.

      ATIVAN (lorazepam) tablets: FDA-approved prescribing information, Boxed Warning, Warnings and Drug Interactions — Bausch Health US LLC; US Food and Drug Administration (2025)

  4. Step 4

    What independent research has found since

    What has been learned by people who were not selling it?

  5. Step 5

    What still is not known

    Which questions you might reasonably have has nobody answered yet?

    • The label itself says effectiveness beyond four months was never systematically assessed. How long has this prescription been running?
    • The dependence boxed warning arrived in 2020. What was the label telling prescribers for the forty-three years before that?
    • Twenty-nine submissions against the application, and the trials still are not on the label. What did they show?

Deciding about lorazepam?

Open lorazepam (Ativan) in veisund

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