Medication approval journey

lorazepam (Ativan)

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

page first published · last updated

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.

what the lorazepam warnings mean

label facts below are read from the lorazepam tablets FDA label on DailyMed, set id 6c5356b1-c199-49ad-bb00-fd67c6691f74, version 10, effective august 7, 2026, the version the dossier above cites. this is an older-format label without numbered sections, so the brackets name the section instead. every source is linked at the end of this section. last checked 2026-10-13.

lorazepam was approved on september 30, 1977 under the brand ativan, and the tablet label approves one thing: "the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms" [label, indications; approval]. the same paragraph adds two sentences most people never hear: "anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic", and the effectiveness of lorazepam beyond four months "has not been assessed by systematic clinical studies" [label, indications]. about 2.2 million americans filled a prescription for it in 2024, down from about 3.5 million in 2014, and the number of prescriptions fell from about 15.9 million to 9.1 million, a 43% drop larger than the survey’s margin of error [meps]. it is a schedule iv controlled substance [label, drug abuse and dependence]. its label opens with the three-part boxed warning the fda rewrote for every benzodiazepine in september 2020 and continues with warnings on depression, breathing, newborns and driving. this section says what each means in plain words, what the label itself says about tapering, what the label does and does not say about its own trials, which side effects it counts and how often, and what independent research has found, in both directions. every number is from the label, an fda communication, or a study in the library, and each source is linked at the end.

this is information to take to a prescriber. nothing here is a reason to start, stop or change a dose on your own; with this drug the label says that stopping abruptly after continued use can cause withdrawal reactions that are life-threatening, and the taper language quoted below is the label’s, not ours.

the boxed warning, part one: opioids

the first part says that using benzodiazepines with opioids "may result in profound sedation, respiratory depression, coma, and death", that the two should be prescribed together only "for patients for whom alternative treatment options are inadequate", at the lowest doses for the shortest time, with the patient followed for slowed breathing and sedation [label, boxed warning]. the warnings section adds the evidence sentence: "observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone", and a dosing instruction that in someone already on an opioid the starting dose of lorazepam should be lower than usual, and the other way round when an opioid is added to lorazepam [label, warnings]. the mechanism is in the interactions section: the two drugs slow breathing through different receptors, benzodiazepines at gaba-a sites and opioids mainly at mu receptors, so they add rather than overlap [label, drug interactions; label-row].

the numbers behind it are observational. among 315,428 insured american adults who filled an opioid prescription between 2001 and 2013, the share also filling a benzodiazepine rose from 9% to 17%, and those taking both had about twice the odds (adjusted odds ratio 2.14) of an emergency visit or admission for opioid overdose [sun-2017]. across 399,230 us opioid overdose deaths from 1999 to 2017, benzodiazepine involvement rose from 8.7% to 21.0%, and a benzodiazepine was present in 33.1% of prescription-opioid deaths in 2017 [tori-2020]. in cdc surveillance for the first half of 2018, 62.6% of opioid deaths in 25 states also involved cocaine, methamphetamine or a benzodiazepine, and illicitly made fentanyl was in about two thirds of them [gladden-2019]. none of these can prove the benzodiazepine caused the deaths; all of them count it there.

the boxed warning, parts two and three: abuse, misuse and addiction; dependence and withdrawal

the second part says benzodiazepines expose users to "risks of abuse, misuse, and addiction, which can lead to overdose or death", that abuse and misuse "commonly involve concomitant use of other medications, alcohol, and/or illicit substances", and that prescribers should assess each person’s risk before prescribing and throughout treatment [label, boxed warning]. the label adds that "even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication", that misuse often but not always involves doses above the maximum, and that death "is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol)" [label, drug abuse and dependence].

the third part says continued use "may lead to clinically significant physical dependence", that the risks of dependence and withdrawal "increase with longer treatment duration and higher daily dose", and that stopping abruptly or cutting the dose quickly after continued use "may precipitate acute withdrawal reactions, which can be life-threatening", so the dose should come down by a gradual taper [label, boxed warning]. the fda required this wording on every benzodiazepine in september 2020; its point is that dependence can develop when the drug is taken exactly as prescribed, which is a reason not to stop on one’s own [fda-2020]. the label lists the acute withdrawal signs, from anxiety, insomnia, tremor, racing heart, raised blood pressure, panic attacks and sensitivity to light and sound to the severe ones: catatonia, convulsions, delirium tremens, hallucinations, mania, psychosis, seizures and suicidality. a protracted syndrome, with anxiety, cognitive impairment, depression, insomnia, crawling-skin sensations, weakness, tremor, muscle twitches, tingling and tinnitus, can persist beyond four to six weeks and "may last weeks to more than 12 months", and the label concedes "there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used" [label, warnings; drug abuse and dependence]. it also names one way to trigger acute withdrawal that is not a missed dose: flumazenil, the benzodiazepine antagonist used in overdose, which "may precipitate acute withdrawal reactions, including seizures" in someone who is physically dependent [label, warnings; overdosage].

on tolerance the label says it "may develop to the therapeutic effect", while "little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines" [label, drug abuse and dependence]. unlike the clonazepam label, this one reports nothing about how people fared when they came off it in trials; there is no clinical studies section at all [approval].

what the label says about tapering

quoted so that it is the label’s and not ours: "to reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly" [label, dosage and administration]. the warnings section adds that "a patient-specific plan should be used to taper the dose", and that people at the greatest risk of withdrawal are "those who take higher dosages, and those who have had longer durations of use" [label, warnings]. the label gives no step size and no schedule; the clonazepam label does, and that explainer quotes it [clonazepam-explainer].

on how long to stay on it, the label says the physician "should periodically reassess the usefulness of the drug for the individual patient", having already said that effectiveness beyond four months has not been assessed [label, indications]. the uk guideline for these medicines says to taper in steps proportionate to the current dose, so the steps shrink as the dose falls, and to expect that withdrawal "may take several months or more" [nice-2022]. a cochrane review of 38 trials in 2,543 long-term benzodiazepine users found no add-on medication that reliably improved the chance of stopping, leaving the gradual taper as the mainstay [baandrup-2018]. lorazepam is absorbed with 90% bioavailability, peaks at about two hours, and has a mean half-life of about 12 hours; it is cleared by conjugation (glucuronidation) rather than by the liver’s cytochrome enzymes, and the label reports no accumulation with dosing for up to six months [label, clinical pharmacology].

the other warnings, in plain words

beyond the boxed warning, the label’s warnings and precautions sections carry:

  • depression and suicide: "pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam", and lorazepam "is not recommended for use in patients with a primary depressive disorder or psychosis". in people with depression "a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate antidepressant therapy" [label, warnings; precautions]. this sits oddly beside the indication, which includes anxiety "associated with depressive symptoms"; the label does not reconcile the two, and this page does not try to.
  • breathing: benzodiazepines "both used alone and in combination with other cns depressants, may lead to potentially fatal respiratory depression"; caution in anyone with compromised breathing such as copd or sleep apnea [label, warnings; precautions]. worsening of sleep apnea and of obstructive pulmonary disease are on the adverse-reaction list [label, adverse reactions].
  • newborns: use late in pregnancy can leave a baby sedated (slow breathing, lethargy, floppiness) or in withdrawal (overactive reflexes, irritability, restlessness, tremors, inconsolable crying, feeding difficulties). published observational studies "do not report a clear association" with major birth defects; early reports of malformations with diazepam and chlordiazepoxide were not confirmed by the majority of later studies that adjusted for alcohol, tobacco and other drugs; rabbit studies showed occasional anomalies "without relationship to dosage" [label, warnings; pregnancy]. lorazepam is present in breast milk, with reports of sedation, poor feeding and poor weight gain in infants exposed through milk [label, nursing mothers].
  • driving and alcohol: patients "should be warned not to operate dangerous machinery or motor vehicles and that their tolerance for alcohol and other cns depressants will be diminished" [label, warnings]. the interactions section lists what adds to the sedation: alcohol, barbiturates, antipsychotics, sleeping pills, other anxiety drugs, antidepressants, opioids, sedating antihistamines, anticonvulsants and anaesthetics [label, drug interactions; label-row].
  • clozapine: the one named drug-drug combination. lorazepam with clozapine "may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest" [label, drug interactions].
  • valproate and probenecid: both raise lorazepam levels by blocking its conjugation, and the label says the lorazepam dose "should be reduced to approximately 50%" with either. theophylline and aminophylline may reduce its sedative effect [label, drug interactions].
  • paradoxical reactions: anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbance, sexual arousal and hallucinations "may occur", more likely in children and the elderly; "should these occur, use of the drug should be discontinued" [label, precautions; adverse reactions].
  • older people: the trials were "not adequate to determine whether subjects aged 65 and over respond differently", but "the incidence of sedation and unsteadiness was observed to increase with age"; the starting dose for elderly or debilitated patients "should not exceed 2 mg" a day [label, precautions; geriatric use]. in one study of intravenous doses, clearance was 20% lower in 15 subjects aged 60 to 84 than in 15 aged 19 to 38 [label, clinical pharmacology].
  • liver, blood and the gut: caution in severe liver disease, where lorazepam may worsen hepatic encephalopathy; some patients have developed low white cells (leukopenia) and raised ldh, so the label recommends periodic blood counts and liver tests during long-term therapy. rats dosed for more than a year developed dilation of the oesophagus, reversible only if treatment stopped within two months; the no-effect dose was about six times the maximum human dose, the label calls the clinical significance "unknown", and asks for "frequent monitoring for symptoms of upper gi disease" in prolonged use and in older people [label, precautions; laboratory tests].
  • contraindications: hypersensitivity to benzodiazepines, and acute narrow-angle glaucoma [label, contraindications]. safety and effectiveness under 12 "have not been established" [label, precautions].

what the label says about its own trials, which is almost nothing

the marketed tablet label has no clinical studies section. it does not say how many trials supported the 1977 approval, how long they ran, what they measured or what they showed; the fda has not published its original review, as for most approvals of that era [approval]. the only trial-scale figure anywhere in the label is the side-effect sample, "about 3500 patients treated for anxiety", reported without a placebo group, a duration or a study design [label, adverse reactions]. the one statement about duration is the four-month line in the indications [label, indications].

the dosing section describes a usual range of 2 to 6 mg a day in divided doses, "the largest dose being taken before bedtime", within a span of 1 to 10 mg; for anxiety most patients start on 2 to 3 mg a day in two or three doses; "for insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime"; for elderly or debilitated patients, 1 to 2 mg a day [label, dosage and administration]. so sleep is on this label in a way it is not on, for example, the trazodone label, but only as a dose for insomnia that is itself caused by anxiety or situational stress, not as an indication [label, indications; dosage and administration].

the two largest randomised trials of lorazepam in the library are not of the tablet and not of anxiety. in 518 people with generalised convulsive status epilepticus, intravenous lorazepam stopped the seizure in 64.9% against 43.6% with phenytoin [treiman-1998]; in 205 people treated by paramedics before reaching hospital, intravenous lorazepam ended the seizure in 59.1% against 21.1% on placebo, an odds ratio of 4.8, without more respiratory complications [alldredge-2001]. the injection has its own label, which this page does not read. a cochrane review of 20 small trials in 695 people found benzodiazepines, most often lorazepam, calmed acute psychotic agitation about as well as antipsychotics with fewer movement side effects, and rated the evidence poor: most trials were underpowered, randomisation was poorly reported, and 6 of the 20 were industry-funded [zaman-2017]. neither emergency seizures nor agitation is an approved use of the tablet [label, indications].

side effects, with the label’s numbers

the label gives four figures, all from the uncontrolled sample of about 3,500 people treated for anxiety: sedation 15.9%, dizziness 6.9%, weakness 4.2%, unsteadiness 3.4%, with "the incidence of sedation and unsteadiness increased with age" [label, adverse reactions]. there is no placebo rate to set beside any of them, no dropout rate and no figure by dose; the label says only that most benzodiazepine reactions "are dose dependent, with more severe effects occurring with high doses" [label, adverse reactions].

the rest of the list is unquantified: fatigue, drowsiness, amnesia and memory impairment, confusion, disorientation, depression and "unmasking of depression", disinhibition, euphoria, suicidal ideation or attempt, ataxia, extrapyramidal symptoms, seizures, tremor, vertigo, double or blurred vision, slurred speech, change in libido, impotence, decreased orgasm, headache, coma; respiratory depression and apnea; nausea, appetite change, constipation, jaundice and raised liver enzymes; allergic and anaphylactoid reactions, hair loss; low sodium from inappropriate antidiuretic hormone; low platelets, white cells or all blood cell lines; and hypothermia [label, adverse reactions]. small drops in blood pressure "are usually not clinically significant, probably being related to the relief of anxiety" [label, adverse reactions]. in overdose the picture runs from drowsiness to coma, and overdose "in combination with other cns depressants (including alcohol and opioids) may be fatal" [label, overdosage].

what the research says, in both directions

in favour. in the two emergency-seizure trials, intravenous lorazepam outperformed phenytoin and placebo by wide margins, 64.9% against 43.6% and 59.1% against 21.1%, which is why it is a first-line emergency drug in that setting [treiman-1998; alldredge-2001]. for acute agitation in psychosis, the cochrane review found it about as effective as antipsychotics with fewer movement side effects, on poor-quality evidence [zaman-2017]. its pharmacology is simpler than some benzodiazepines’: 90% bioavailability, a 12-hour half-life, clearance by conjugation rather than cytochrome enzymes, and no accumulation over six months of dosing, so the label names only valproate and probenecid as drugs that raise its level [label, clinical pharmacology; drug interactions].

against, or smaller than it sounds. the approved use rests on trials the label does not describe, with no controlled efficacy figure anywhere on it, and the label itself says effectiveness beyond four months "has not been assessed" [label, indications; approval]. the emergency trials are of a different product in a different situation and say nothing about daily tablets for anxiety [treiman-1998; alldredge-2001]. a meta-analysis of 13 observational studies of people who had taken benzodiazepines for about 10 years found them scoring moderately worse than controls across every cognitive domain tested (effect size 0.74) [barker-2004], which sits beside the label’s own statement that little tolerance develops to the cognitive effects. the side-effect figures have no placebo comparison [label, adverse reactions].

the warnings, measured. the opioid warning’s size is in the three studies above: twice the odds of an overdose visit with concurrent prescriptions [sun-2017], a benzodiazepine present in one in three prescription-opioid deaths [tori-2020], and nearly two thirds of opioid deaths involving another drug [gladden-2019]. the dependence warning’s timescale is in the uk guideline [nice-2022] and in the cochrane finding that no medicine makes stopping reliably easier [baandrup-2018]. on dementia, the two best class studies point in opposite directions and neither is lorazepam-specific: a case-control study of 1,796 older adults with alzheimer’s disease found past benzodiazepine use beyond three months associated with about 1.5 times the odds [billioti-2014], while a prospective cohort of 3,434 adults aged 65 and over followed for 7.3 years found no increased dementia risk in the heaviest users and no dose-response [gray-2016].

questions to ask your prescriber about lorazepam

each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.

  • the label says effectiveness beyond four months has not been assessed and that the usefulness of the drug should be reassessed periodically. how long is the plan, and when will we review it?
  • if we ever reduce or stop, the label says to taper, to pause or step back up if withdrawal appears, and then go more slowly, but gives no schedule. what would mine look like, and how would we tell withdrawal from my anxiety coming back?
  • is any opioid in my life, prescribed or not, including a cough medicine or a pain pill after surgery? the boxed warning is about the combination, and the label says the starting dose of each should be lower when the other is already there.
  • the label says pre-existing depression may emerge or worsen, and that lorazepam is not recommended in a primary depressive disorder without antidepressant treatment. does that apply to me?
  • i take valproate, probenecid, clozapine or theophylline. the label names each of these; is anything i take on that list?
  • the label says sedation and unsteadiness increase with age and sets a 2 mg starting ceiling for older people. if i am over 65, where does my dose sit?
  • if i am taking it for sleep: the label’s only sleep dose is for insomnia due to anxiety or situational stress. what is this being prescribed for, and for how long?
  • the label asks for periodic blood counts and liver tests on long-term therapy. have those been ordered?
  • is naloxone in the house, and do the people around me know how to use it, given what else is prescribed here?

questions people ask

what does the ativan (lorazepam) black box warning mean?
it has three parts, rewritten by the fda for every benzodiazepine in september 2020. first, taking a benzodiazepine with an opioid can cause profound sedation, slowed breathing, coma and death, so the two should be combined only when alternatives are inadequate, at the lowest doses for the shortest time. second, benzodiazepines carry risks of abuse, misuse and addiction that can lead to overdose or death, and prescribers should assess that risk before and during treatment. third, continued use can cause physical dependence, and stopping abruptly or cutting the dose quickly can cause withdrawal reactions that can be life-threatening, so the dose should come down by a gradual taper. it is a warning about how the drug is used, not an instruction to stop it.
is lorazepam addictive?
the label says benzodiazepines expose users to risks of abuse, misuse and addiction, that even taking them as prescribed may put people at risk of misuse, and that physical dependence, which the label distinguishes from addiction, can develop with continued use, with the risk rising with higher doses and longer treatment. dependence means withdrawal symptoms on stopping, which the label says can be life-threatening and in some people last more than a year. lorazepam is a schedule iv controlled substance. that is why the label says to taper rather than stop.
what are the most common lorazepam side effects?
the label reports four rates from a sample of about 3,500 people treated for anxiety, with no placebo comparison: sedation 15.9%, dizziness 6.9%, weakness 4.2% and unsteadiness 3.4%, with sedation and unsteadiness increasing with age. the rest of its list has no rates: memory impairment, confusion, depression, disinhibition, slurred speech, blurred vision, changes in libido, and the paradoxical reactions of agitation, aggression, rage and hallucinations. the label says little tolerance develops to the memory and cognitive effects.
what happens if you stop lorazepam suddenly?
the label says abrupt stopping or a rapid dose cut after continued use can cause acute withdrawal reactions that can be life-threatening, including seizures, catatonia, delirium tremens, hallucinations, mania, psychosis and suicidality, and that a protracted syndrome of anxiety, cognitive impairment, depression, insomnia, crawling-skin sensations, tremor, tingling and tinnitus can last weeks to more than 12 months. its instruction is a gradual taper, pausing or returning to the previous step if withdrawal appears and then going more slowly; it gives no schedule. a taper plan belongs with a prescriber.
can you take lorazepam with opioids or alcohol?
the boxed warning says benzodiazepines with opioids may cause profound sedation, respiratory depression, coma and death, and that the combination should be reserved for people with no adequate alternative, at the lowest doses for the shortest time. the label says tolerance for alcohol will be diminished and lists alcohol first among the drugs that add to lorazepam’s sedation. in the studies behind the warning, people filling both prescriptions had about twice the odds of an overdose emergency visit, and a benzodiazepine was present in one in three prescription-opioid overdose deaths in 2017. the person who can make sure both prescribers know is the patient.
is lorazepam approved for sleep?
not as an indication. the label approves it for anxiety disorders and the short-term relief of anxiety symptoms. its dosing section does include one sleep line, a single bedtime dose of 2 to 4 mg "for insomnia due to anxiety or transient situational stress", so sleep appears on the label only as a symptom of anxiety. the label describes no sleep trial, and its four-month limit on assessed effectiveness applies to every use.
does lorazepam cause dementia?
unsettled, and nothing in the library is lorazepam-specific. a 2014 case-control study of 1,796 older adults with alzheimer’s disease found past benzodiazepine use beyond three months associated with about 1.5 times the odds, rising with longer use. a 2016 prospective cohort of 3,434 adults aged 65 and over, followed for 7.3 years, found no increased dementia risk in the heaviest users and no dose-response, which argues against causation; anxiety and insomnia can be early symptoms of dementia that lead to a prescription years before diagnosis. what is better established is that long-term users score worse on cognitive tests while taking the drug, and the label says tolerance to those effects is limited.
how is lorazepam different from xanax (alprazolam) or klonopin (clonazepam)?
all three carry the same 2020 boxed warning and the same dependence and withdrawal language, and all three are schedule iv. the label facts that differ: lorazepam has a mean half-life of about 12 hours, is cleared by conjugation rather than cytochrome enzymes so fewer drugs change its level, and its tablet label approves anxiety only, with no clinical studies section and no taper schedule. the alprazolam and clonazepam labels each have their own explainer on this site [alprazolam-explainer; clonazepam-explainer], and alprazolam and lorazepam are compared side by side on the comparison page [compare]. nothing in any of the labels is a reason to prefer one drug; that is a prescriber’s decision.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

  1. lorazepam tablets prescribing information, fda label on dailymed (set id 6c5356b1-c199-49ad-bb00-fd67c6691f74, version 10, effective august 7, 2026; remedyrepack, anda 072927): boxed warning; indications and usage; contraindications; warnings; precautions, including information for patients, essential laboratory tests, drug interactions, pregnancy, nursing mothers and geriatric use; adverse reactions; drug abuse and dependence; overdosage; dosage and administration; clinical pharmacology
  2. drugs@fda, nda 017794 (ativan), approved september 30, 1977; no fda review of the original application is published, as for most approvals of that era, and the tablet label has no clinical studies section
  3. ahrq medical expenditure panel survey, prescribed medicines public-use files 2014 (hc-168a) and 2024 (hc-254a): people with at least one lorazepam purchase and prescriptions, weighted; the 2014 to 2024 prescription fall is larger than the survey’s margin of error; computed by veisund, method on the usage section of this page
  4. fda drug safety communication, september 2020: fda requiring boxed warning updated to improve safe use of benzodiazepine drug class (library row)
  5. the lorazepam label’s interaction list, read for the library: alcohol, antidepressants and antipsychotics named together as drugs that add to its sedation (ativan prescribing information, bausch health, november 2025, a different labeler’s copy of the same text) (library row)
  6. sun ec, et al. association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis. bmj 2017 (library row)
  7. tori me, larochelle mr, naimi ts. alcohol or benzodiazepine co-involvement with opioid overdose deaths in the united states, 1999 to 2017. jama network open 2020 (library row)
  8. gladden rm, et al. changes in opioid-involved overdose deaths by opioid type and presence of benzodiazepines, cocaine, and methamphetamine, 25 states, 2017 to 2018. mmwr 2019 (library row)
  9. national institute for health and care excellence. medicines associated with dependence or withdrawal symptoms (ng215), 2022 (library row)
  10. baandrup l, et al. pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users. cochrane database of systematic reviews 2018 (library row)
  11. barker mj, et al. cognitive effects of long-term benzodiazepine use: a meta-analysis. cns drugs 2004 (library row)
  12. treiman dm, et al. a comparison of four treatments for generalized convulsive status epilepticus. new england journal of medicine 1998 (intravenous lorazepam, 518 patients) (library row)
  13. alldredge bk, et al. a comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus. new england journal of medicine 2001 (intravenous lorazepam, 205 patients) (library row)
  14. zaman h, et al. benzodiazepines for psychosis-induced aggression or agitation. cochrane database of systematic reviews 2017 (20 trials, 695 participants) (library row)
  15. billioti de gage s, et al. benzodiazepine use and risk of alzheimer’s disease: case-control study. bmj 2014 (a benzodiazepine class study, not lorazepam-specific) (library row)
  16. gray sl, et al. benzodiazepine use and risk of incident dementia or cognitive decline: prospective population based study. bmj 2016 (a benzodiazepine class study, not lorazepam-specific) (library row)
  17. what the alprazolam (xanax) warnings mean, the companion explainer on this site: the same 2020 boxed warning, that label’s taper wording and side-effect tables
  18. what the clonazepam (klonopin) warnings mean, the companion explainer on this site, with the one benzodiazepine label on this site that prints a taper schedule
  19. alprazolam vs lorazepam, the side-by-side comparison page on this site

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?

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