Drug Monograph

Lorazepam

Ativan, Loreev XR
Benzodiazepine (3-Hydroxy) · Oral · IV · IM · Schedule IV
Pharmacokinetic Profile
Half-Life
~12 h (range 8–25 h)
Metabolism
Direct glucuronidation (UGT) — no CYP450
Protein Binding
~85%
Bioavailability
~90% (oral)
Volume of Distribution
1.0–1.3 L/kg
Tmax
~2 h (oral); 1–3 min (IV)
Clinical Information
Drug Class
Benzodiazepine
Available Doses
Oral: 0.5, 1, 2 mg; XR: 1, 2, 3 mg; Inj: 2, 4 mg/mL
Route
PO, IV, IM
Renal Adjustment
Caution with frequent dosing
Hepatic Adjustment
Yes — use caution; lower doses in severe impairment
Pregnancy
Avoid; risk of neonatal sedation/withdrawal
Lactation
Not recommended
Schedule
C-IV (Controlled)
Generic Available
Yes
Black Box Warning
Yes — 3 warnings
Rx

Indications

IndicationApproved PopulationTherapy TypeStatus
Anxiety disorders / short-term relief of anxiety symptomsAdults (≥12 years for oral)MonotherapyFDA Approved
Anxiety-related insomniaAdultsMonotherapy (short-term)FDA Approved
Status epilepticusAdults ≥18 years (IV)First-line emergency treatmentFDA Approved
Anesthesia premedicationAdults (IV/IM)AdjunctiveFDA Approved

Lorazepam is a 3-hydroxy benzodiazepine widely used across psychiatry, emergency medicine, anesthesiology, and critical care. Its key pharmacokinetic advantage over many other benzodiazepines is metabolism via direct glucuronidation rather than CYP450 oxidation, making it a preferred choice in patients with hepatic dysfunction or those on multiple medications. For anxiety, the FDA has not established efficacy beyond 4 months of continuous use. Lorazepam IV is considered first-line for convulsive status epilepticus by both the American Epilepsy Society and Neurocritical Care Society guidelines.

Off-Label Uses

Alcohol withdrawal syndrome: Widely used as first-line; symptom-triggered dosing guided by CIWA-Ar scale. Evidence quality: High.

Chemotherapy-induced anticipatory nausea/vomiting: Adjunctive or breakthrough treatment. Evidence quality: Moderate.

Acute agitation / rapid tranquilisation: IM lorazepam alone or with haloperidol. Evidence quality: High (hospital practice).

Psychogenic catatonia: Lorazepam challenge (1–2 mg IV) is both diagnostic and therapeutic. Evidence quality: Moderate.

Panic disorder: Used off-label when first-line SSRIs/SNRIs are insufficient. Evidence quality: Moderate.

Dose

Dosing

Oral — Anxiety and Insomnia

Clinical ScenarioStarting DoseMaintenance DoseMaximum DoseNotes
Generalised anxiety — mild to moderate1 mg BID–TID2–3 mg/day divided6 mg/dayTitrate gradually; reassess after 4 months
Largest dose before bedtime (FDA PI)
Generalised anxiety — moderate to severe1 mg TID2–6 mg/day divided10 mg/dayUsual effective range 2–6 mg/day
Full daily range: 1–10 mg/day (FDA PI)
Anxiety-related insomnia2 mg at bedtime2–4 mg at bedtime4 mg at bedtimeSingle nightly dose; short-term use only
Not for chronic primary insomnia
Elderly or debilitated patients1–2 mg/day dividedTitrate as needed and toleratedLowest effectiveIncreased sensitivity to sedation and unsteadiness
Initial dose should not exceed 2 mg total (FDA PI)
Conversion to Loreev XRTotal daily IR dose, once daily AMEqual to total daily IR dosePer IR total daily doseOnly for patients stable on TID immediate-release dosing; capsules available as 1, 2, 3 mg
Swallow whole or sprinkle on applesauce; for dose adjustment, switch back to IR tablets

Parenteral — Status Epilepticus and Procedural

Clinical ScenarioStarting DoseMaintenance DoseMaximum DoseNotes
Status epilepticus (adults ≥18)4 mg IV at 2 mg/minRepeat 4 mg after 10–15 min if seizures persist8 mg totalFirst-line per AES guidelines (0.1 mg/kg, max 4 mg/dose)
Have airway equipment immediately available
Premedication — IV sedation2 mg IV total (or 0.044 mg/kg)N/A (single dose)4 mgGive 15–20 min before procedure for amnesia
Reduce dose in patients >50 years
Premedication — IM0.05 mg/kg IMN/A (single dose)4 mgGive at least 2 hours before procedure for optimal effect
IM absorption is rapid and complete
Alcohol withdrawal (off-label) — symptom-triggered1–4 mg IV/IM q1h PRNCIWA-Ar guided: dose when score ≥8–10Clinician discretionPreferred over diazepam in hepatic impairment
Taper as symptoms resolve
Acute agitation (off-label)1–2 mg IMRepeat q30–60 min PRNClinician discretionOften combined with haloperidol 5 mg IM
Monitor for respiratory depression
Clinical Pearl: Why Lorazepam in Hepatic Impairment?

Unlike diazepam, alprazolam, and midazolam, lorazepam bypasses the CYP450 system entirely. Its metabolism occurs exclusively through direct glucuronidation (UGT), which is relatively preserved in liver disease. The FDA PI notes that the half-life of lorazepam is not significantly altered by hepatic dysfunction. This makes lorazepam the preferred benzodiazepine for patients with cirrhosis, alcoholic liver disease, or those on CYP450-inhibiting medications. However, caution is still warranted in severe hepatic insufficiency, as glucuronidation capacity can eventually become impaired, and lorazepam may worsen hepatic encephalopathy.

PK

Pharmacology

Mechanism of Action

Lorazepam is a 3-hydroxy benzodiazepine that exerts its effects through binding to the benzodiazepine site on the GABA-A receptor complex. By allosterically enhancing GABA-mediated chloride conductance, lorazepam increases the frequency of chloride channel opening, producing neuronal hyperpolarisation and membrane stabilisation. This translates into anxiolytic, sedative, anticonvulsant, muscle-relaxant, and amnestic effects. Compared to diazepam, lorazepam has lower lipid solubility, which limits its initial redistribution from the brain after a single dose and accounts for its longer duration of anticonvulsant action (over 12 hours vs approximately 20–30 minutes for diazepam). This property makes lorazepam the preferred benzodiazepine for sustained seizure control in status epilepticus despite a slightly slower onset than diazepam.

ADME Profile

ParameterValueClinical Implication
AbsorptionBioavailability ~90% (oral and IM); Tmax ~2 h (oral); onset 1–3 min (IV), 15–30 min (IM)Oral onset slower than IV; IM absorption is rapid and complete, unlike diazepam IM which is erratic
DistributionVd 1.0–1.3 L/kg; ~85% protein bound (albumin); crosses placenta and blood-brain barrierLow lipid solubility limits redistribution, prolonging CNS duration of action; enters breast milk
MetabolismDirect hepatic glucuronidation to lorazepam glucuronide (inactive); no CYP450 involvement; no active metabolitesMinimal hepatic drug interaction potential; safe in liver disease (glucuronidation preserved); no accumulation on repeated dosing
Eliminationt½ ~12 h (range 8–25 h); clearance 0.7–1.2 mL/min/kg; 88% urine, 7% faeces; <0.5% excreted as unchanged drugAge minimally affects kinetics; clearance modestly reduced (~20%) in elderly via IV route; glucuronide metabolite may be dialysable
SE

Side Effects

≥10% Very Common
Adverse EffectIncidenceClinical Note
Sedation15.9%Most frequent effect; dose-dependent; incidence increases with age; typically attenuates over days to weeks
1–10% Common
Adverse EffectIncidenceClinical Note
Dizziness6.9%May contribute to falls in elderly; assess at each visit
Weakness4.2%Generalised muscle relaxation effect; asthenia reported alongside
Unsteadiness3.4%Incidence increases with age; significant fall risk in elderly
Reported (frequency not specified) Other Recognised Adverse Effects
Adverse EffectIncidenceClinical Note
Amnesia / Memory ImpairmentFrequentAnterograde amnesia; dose-dependent; exploited therapeutically for procedural sedation but problematic for daily functioning
Drowsiness / FatigueFrequentOverlaps with sedation; may impair driving and occupational performance
Depression / Unmasking of DepressionReportedPre-existing depression may worsen; not recommended as monotherapy in depressive disorders
Confusion / DisorientationReportedMore common in elderly; may mimic delirium
AtaxiaReportedDose-related; contributes to fall risk along with unsteadiness
Dysarthria / Slurred SpeechReportedDose-dependent; particularly notable at higher doses
HypotensionReportedSmall decreases in blood pressure; usually not clinically significant; more relevant with IV administration
Change in Libido / ImpotenceReportedBoth increased and decreased libido reported; enquire actively
Nausea / GI SymptomsReportedIncludes constipation and appetite changes
Visual DisturbanceReportedDiplopia, blurred vision; dose-related
Serious Serious Adverse Effects (Any Frequency)
Adverse EffectEstimated FrequencyTypical OnsetRequired Action
Physical Dependence / Withdrawal SeizuresCommon with prolonged useOn discontinuation; reported after as little as 1 weekNever stop abruptly; gradual taper essential; seizures can be life-threatening
Respiratory Depression / ApnoeaDose-dependent; higher with IV routeMinutes after IV dose; hours after oralDiscontinue; ventilatory support; flumazenil as adjunct (caution: may precipitate seizures)
Paradoxical Reactions (rage, agitation, aggression)RareAny time; more likely in elderly and childrenDiscontinue lorazepam immediately
Suicidal Ideation / AttemptUncommonAny time; risk elevated with comorbid depressionLimit prescription quantity; ensure concurrent antidepressant therapy; psychiatric evaluation
Anaphylactoid Reactions / AngioedemaVery rareFirst or subsequent dosesDiscontinue permanently; emergency airway management if tongue/glottis involved; do not rechallenge
SIADH / HyponatraemiaVery rareVariableCheck serum sodium; fluid restrict; discontinue if severe
Blood Dyscrasias (agranulocytosis, pancytopenia, thrombocytopenia)Very rareVariable; monitor on long-term therapyPeriodic CBC recommended; discontinue if significant cytopenias develop
Neonatal Sedation / WithdrawalExpected with late-pregnancy exposureBirth / neonatal periodMonitor neonate for respiratory depression, hypotonia, feeding difficulties, withdrawal signs
Discontinuation Discontinuation & Withdrawal
Withdrawal Symptoms
Can appear after 1 week
Acute: Insomnia, anxiety, tremor, sweating, nausea, seizures (life-threatening)
Protracted Withdrawal
Weeks to >12 months
Features: Anxiety, cognitive impairment, depression, insomnia, paresthesia, tinnitus
Managing Sedation in the Elderly

Sedation and unsteadiness incidence increases with age. The AGS Beers Criteria lists benzodiazepines as potentially inappropriate in older adults due to fall risk and cognitive impairment. If lorazepam must be used, start at the lowest dose (0.5 mg) and limit duration. Carefully evaluate the risk-benefit at every encounter, particularly in patients on other CNS-depressant medications.

Int

Drug Interactions

Lorazepam is metabolised by direct glucuronidation (UGT) and does not involve CYP450 enzymes. This confers a significantly cleaner drug interaction profile compared to benzodiazepines such as alprazolam, diazepam, and midazolam. The clinically important interactions are pharmacodynamic (additive CNS depression) and involve UGT inhibitors that reduce glucuronidation clearance.

MajorOpioids (all)
MechanismAdditive CNS/respiratory depression via GABA-A and mu-opioid synergy
EffectProfound sedation, respiratory depression, coma, death
ManagementAvoid if possible; if essential, use lowest doses and shortest duration; close monitoring mandatory
FDA Boxed Warning
MajorClozapine
MechanismSynergistic CNS depression; mechanism not fully elucidated
EffectMarked sedation, excessive salivation, hypotension, ataxia, delirium, respiratory arrest
ManagementAvoid concomitant use; if absolutely necessary, use extreme caution with close cardiorespiratory monitoring
FDA PI
MajorAlcohol
MechanismAdditive GABAergic CNS depression; alcohol also increases LOREEV XR release rate in vitro
EffectEnhanced sedation, respiratory depression, impaired motor function
ManagementAbsolute avoidance; counsel at every visit
FDA PI
ModerateValproate / Valproic Acid
MechanismUGT inhibition reducing lorazepam glucuronidation
EffectIncreased lorazepam plasma concentrations, reduced clearance
ManagementReduce lorazepam dose by approximately 50% when co-administered with valproate
FDA PI
ModerateProbenecid
MechanismUGT inhibition; may also reduce renal excretion of glucuronide
EffectMore rapid onset, prolonged effect, increased half-life, decreased total clearance
ManagementReduce lorazepam dose by approximately 50% when co-administered
FDA PI
ModerateOther CNS Depressants
MechanismAdditive CNS depression
EffectIncreased sedation, respiratory depression, psychomotor impairment
ManagementUse caution and monitor; includes barbiturates, antipsychotics, sedating antidepressants, anticonvulsants, sedative antihistamines
FDA PI
ModerateUGT Inhibitors (general)
MechanismInhibition of glucuronidation pathway
EffectIncreased lorazepam exposure and risk of adverse reactions
ManagementAvoid initiating UGT inhibitors during LOREEV XR treatment; if needed, switch to IR tablets for dose adjustment
LOREEV XR PI
MinorTheophylline / Aminophylline
MechanismAdenosine receptor antagonism may counteract benzodiazepine sedation
EffectReduced sedative effect of lorazepam
ManagementBe aware of potential reduced efficacy; may need dose adjustment if sedation is the therapeutic goal
FDA PI
Key Advantage: Minimal CYP450 Interactions

Unlike alprazolam (CYP3A4), diazepam (CYP2C19/3A4), and midazolam (CYP3A4), lorazepam is not affected by azole antifungals, macrolide antibiotics, HIV protease inhibitors, or grapefruit juice. This makes lorazepam the preferred benzodiazepine in patients on complex medication regimens, particularly those involving CYP3A4 or CYP2C19 inhibitors.

Mon

Monitoring

  • Sedation & Psychomotor FunctionEach visit during titration; q3 months
    Routine
    Assess daytime sedation, driving safety, and occupational functioning. Elderly patients require particular attention.
  • Abuse / Misuse RiskBaseline, each visit
    Routine
    Standardised screening before prescribing. Monitor for dose escalation, early refill requests, multiple prescribers.
  • Mood & SuicidalityEach visit
    Routine
    Pre-existing depression may emerge or worsen. Not recommended for primary depressive disorders without concurrent antidepressant therapy.
  • CBC & Liver FunctionBaseline; periodically on long-term therapy
    Routine
    Leukopenia and elevated LDH have been reported. Periodic blood counts and LFTs recommended for patients on prolonged therapy (FDA PI).
  • Respiratory FunctionBaseline; ongoing in COPD/sleep apnoea
    Trigger-based
    Use with caution in compromised respiratory function. Worsening of sleep apnoea and COPD reported. Continuous monitoring essential with IV administration.
  • Fall Risk (Elderly)Baseline, q3 months
    Routine
    Unsteadiness and ataxia are dose-dependent. Consider Timed Up and Go test. Deprescribing should be considered after any fall.
  • Upper GI SymptomsPeriodically on prolonged use
    Trigger-based
    Esophageal dilation observed in long-term rat studies. Monitor for symptoms of upper GI disease, particularly in elderly on prolonged therapy.
  • Treatment Duration Reviewq3 months
    Routine
    FDA has not established efficacy beyond 4 months. Document clinical justification for continued use. Consider tapering when anxiety is well-managed.
CI

Contraindications & Cautions

Absolute Contraindications

  • Known hypersensitivity to lorazepam, other benzodiazepines, or any formulation component
  • Acute narrow-angle glaucoma

Relative Contraindications (Specialist Input Recommended)

  • Primary depressive disorder or psychosis — not recommended without concurrent appropriate therapy; benzodiazepines may worsen depression
  • Severe hepatic insufficiency with encephalopathy — may worsen hepatic encephalopathy despite preserved glucuronidation
  • Severe respiratory disease — COPD, severe sleep apnoea; dose-dependent respiratory depression risk
  • Active substance use disorder — high abuse potential; documented risk-benefit required
  • Pregnancy (especially late trimester) — risk of neonatal sedation/withdrawal; avoid unless urgently needed

Use with Caution

  • Elderly patients — increased sensitivity to sedation and unsteadiness; AGS Beers Criteria lists as potentially inappropriate
  • Renal impairment — caution with frequent dosing; lorazepam glucuronide may accumulate
  • Children <12 years — safety and effectiveness not established (oral); paradoxical reactions may be more likely
  • Injection formulation — contains propylene glycol and benzyl alcohol; risk of toxicity with high cumulative IV doses (propylene glycol acidosis) and in neonates (gasping syndrome from benzyl alcohol)
FDA Boxed Warning Risks from Concomitant Use with Opioids

Combined use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no adequate alternative. Use lowest effective doses for the shortest possible duration.

FDA Boxed Warning Abuse, Misuse, and Addiction

Lorazepam exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Assess each patient’s risk before prescribing and throughout treatment.

FDA Boxed Warning Dependence and Withdrawal Reactions

Continued use may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dose reduction can precipitate life-threatening withdrawal reactions including seizures. Use a gradual taper to discontinue. Withdrawal symptoms can appear after as little as one week of treatment and may persist for weeks to more than 12 months.

Pt

Patient Counselling

Purpose of Therapy

Lorazepam is prescribed to reduce anxiety, help with anxiety-related sleep difficulty, or as an emergency medication to stop seizures. It works by calming overactive electrical activity in the brain. It is intended for short-term use and is most effective as part of a broader treatment plan that may include psychological therapy. Because your body can become physically dependent on this medication even at prescribed doses, regular reviews with your prescriber are essential.

How to Take

Take lorazepam exactly as prescribed. For immediate-release tablets, doses are usually divided through the day with the largest dose at bedtime. For extended-release capsules (Loreev XR), take once daily in the morning — swallow whole or open and sprinkle on applesauce (do not chew). Do not increase your dose without medical advice. Store securely; this is a controlled substance.

Drowsiness & Impaired Coordination
Tell patientSedation is the most common effect and may impair driving and concentration. Avoid alcohol completely — it greatly increases sedation and breathing risks. Do not operate machinery until you understand how lorazepam affects you.
Call prescriberIf excessive drowsiness persists beyond the first 1–2 weeks, or if you experience falls, loss of coordination, or slurred speech.
Dependence & Withdrawal
Tell patientYour body can become physically dependent on lorazepam even at prescribed doses and even after short periods of use. Never stop this medication suddenly — this can cause seizures and other life-threatening reactions. Your doctor will help you reduce the dose gradually when it is time to stop.
Call prescriberIf you experience shaking, sweating, rapid heartbeat, severe anxiety, insomnia, or confusion during or after any dose reduction.
Memory Effects
Tell patientLorazepam can cause difficulty forming new memories (anterograde amnesia). This is dose-dependent and may not improve with time. Inform your prescriber if this affects your daily life.
Call prescriberIf memory problems become distressing or affect your ability to work or study.
Mood Changes
Tell patientLorazepam may unmask or worsen depression. Rarely, it can cause unexpected agitation, aggression, or hostility. Family members should be aware of these possibilities.
Call prescriberImmediately if you have thoughts of self-harm, feel more depressed, or experience rage or behavioural changes.
Pregnancy & Breastfeeding
Tell patientLorazepam crosses the placenta and passes into breast milk. Use during pregnancy can cause sedation and withdrawal in newborns. Breastfeeding is not recommended.
Call prescriberImmediately if you become pregnant or are planning pregnancy, so a safe transition plan can be arranged.
Ref

Sources

Regulatory (PI / SmPC)
  1. Ativan (lorazepam) Tablets. Full Prescribing Information. Bausch Health US, LLC. Revised February 2021. FDA LabelPrimary source for oral dosing, adverse reactions (n≈3,500), drug interactions (valproate, probenecid, clozapine), and contraindications.
  2. Ativan (lorazepam) Injection. Full Prescribing Information. West-Ward Pharmaceuticals. FDA LabelSource for IV/IM dosing in status epilepticus (4 mg at 2 mg/min) and premedication, plus injection-specific safety data.
  3. LOREEV XR (lorazepam) Extended-Release Capsules. Full Prescribing Information. Almatica Pharma LLC. Revised August 2021. FDA LabelSource for extended-release dosing, UGT inhibitor interaction guidance, and alcohol-release rate concern.
Key Clinical Trials
  1. Treiman DM, Meyers PD, Walton NY, et al. A comparison of four treatments for generalized convulsive status epilepticus. N Engl J Med. 1998;339(12):792-798. DOIVA Cooperative Study establishing lorazepam as the most effective first-line agent for generalised convulsive status epilepticus.
  2. Alldredge BK, Gelb AM, Isaacs SM, et al. A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus. N Engl J Med. 2001;345(9):631-637. DOILandmark trial demonstrating superiority of IV lorazepam over placebo and comparable efficacy to diazepam for prehospital status epilepticus.
  3. Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus (RAMPART). N Engl J Med. 2012;366(7):591-600. DOIRAMPART trial showing IM midazolam is non-inferior to IV lorazepam for prehospital SE; establishes IV lorazepam as comparator standard.
Guidelines
  1. Brophy GM, Bell R, Claassen J, et al. Guidelines for the evaluation and management of status epilepticus. Neurocrit Care. 2012;17(1):3-23. DOINeurocritical Care Society guidelines recommending IV lorazepam 0.1 mg/kg (max 4 mg) as first-line emergent therapy for convulsive SE.
  2. Glauser T, Shinnar S, Gloss D, et al. Evidence-based guideline: treatment of convulsive status epilepticus in children and adults. Epilepsy Curr. 2016;16(1):48-61. DOIAmerican Epilepsy Society guideline establishing IV lorazepam as Level A evidence for initial SE treatment in adults.
  3. By the 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. DOILists benzodiazepines as potentially inappropriate in older adults due to cognitive impairment, delirium, falls, and fracture risk.
Mechanistic / Basic Science
  1. Sigel E, Ernst M. The benzodiazepine binding sites of GABAA receptors. Trends Pharmacol Sci. 2018;39(7):659-671. DOIComprehensive structural and functional analysis of benzodiazepine binding at GABA-A receptors.
Pharmacokinetics / Special Populations
  1. Greenblatt DJ. Clinical pharmacokinetics of oxazepam and lorazepam. Clin Pharmacokinet. 1981;6(2):89-105. DOIDefinitive PK review establishing lorazepam Vd (1.0–1.3 L/kg), t½ (8–25 h), and demonstrating minimal impact of liver disease on clearance.
  2. Greenblatt DJ, Schillings RT, Kyriakopoulos AA, et al. Clinical pharmacokinetics of lorazepam. I. Absorption and disposition of oral 14C-lorazepam. Clin Pharmacol Ther. 1976;20(3):329-341. DOILandmark single-dose PK study defining 90% bioavailability, 2-hour Tmax, 12-hour half-life, and 88% urinary recovery as glucuronide.
  3. Sharma A, Tripp J. Lorazepam. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan–. Updated May 25, 2024. NCBI BookshelfCurrent clinician-oriented review covering indications, dosing across routes, special populations, and pharmacokinetic parameters.