Bromazepam (United States: Not available): Drug information

For additional information see "Bromazepam (United States: Not available): Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: Canada

APO-Bromazepam;
MED Bromazepam;
TEVA-Bromazepam

Pharmacologic Category

Benzodiazepine

Dosing: Adult

Dosage guidance:

Safety: Reduce dose or avoid use in patients receiving opioids or with significant chronic disease (eg, respiratory compromise). Avoid use in patients with a history of substance use, misuse of medications, or depression (Ref).

Anxiety, monotherapy or adjunctive therapy

Anxiety, monotherapy or adjunctive therapy (alternative agent): Note: Generally used short-term for immediate symptom relief until preferred therapy (eg, serotonin reuptake inhibitor) is effective (eg, 4 to 6 weeks, followed by tapering). Long-term therapy (eg, 3 to 6 mg/day) may be considered in select patients when other treatments are ineffective or poorly tolerated (Ref). Use with caution in patients with posttraumatic stress disorder; benzodiazepines may cause cognitive changes (Ref).

Initial: Oral: 6 to 18 mg/day in equally divided doses. Initial course of treatment should not last longer than 1 week without reassessment of the need for a limited extension. Optimal dosage range: 6 to 30 mg/day. Limited experience with doses up to 60 mg/day.

Debilitated patients: Initial dose: Oral: 3 mg/day in divided doses; may adjust dose cautiously based on response and tolerance.

Discontinuation of therapy : Unless safety concerns require a more rapid withdrawal, gradually taper to detect reemerging symptoms and minimize rebound and withdrawal symptoms (Ref).

Low or moderate dose, no concerns for benzodiazepine use disorder: Taper total daily dose by 20% to 25% every week based on response and tolerability (taper increments will be limited by available dosage forms) (Ref).

Extended or high-dose therapy, or suspected benzodiazepine use disorder: Taper total daily dose by approximately 25% every 1 to 2 weeks based on response, tolerability, and individual patient factors (taper increments will be limited by available dosage forms) (Ref). Reduce dose more rapidly in the beginning and slow the dose reduction as the taper progresses because earlier stages of withdrawal are easier to tolerate (Ref). The optimal duration and taper increment will vary; up to 6 months may be necessary for some patients on higher doses, and a taper rate of 50% every week may be tolerated in some patients (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; initiate therapy conservatively and titrate cautiously.

Dosing: Liver Impairment: Adult

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; initiate therapy conservatively and titrate cautiously.

Severe impairment: Use is contraindicated.

Dosing: Older Adult

Anxiety: Oral: Initial dose: 3 mg/day in divided doses; may adjust dose cautiously based on response and tolerance.

Discontinuation of therapy : Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined: Nervous system: Ataxia, dizziness, drowsiness, drug abuse, drug dependence, withdrawal syndrome

Postmarketing:

Cardiovascular: Cardiac failure, hypotension, palpitations, tachycardia

Dermatologic: Pruritus, skin rash

Endocrine & metabolic: Change in libido, decreased serum glucose, increased serum glucose

Gastrointestinal: Gastrointestinal distress, nausea, vomiting, xerostomia

Genitourinary: Urinary incontinence

Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin, decreased white blood cell count, leukocytosis

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin

Nervous system: Abnormal dreams, anxiety (can be rebound anxiety on withdrawal), confusion, depression, disorientation, emotional disturbance, euphoria, fatigue, headache, hyperactive behavior, impaired consciousness, mood changes, myasthenia, nervousness, seizure

Neuromuscular & skeletal: Muscle spasm

Ophthalmic: Blurred vision, diplopia

Respiratory: Respiratory depression

Contraindications

Hypersensitivity to bromazepam, other benzodiazepines, or any component of the formulation; myasthenia gravis; narrow-angle glaucoma; severe hepatic impairment; severe respiratory disease; sleep apnea

Warnings/Precautions

Concerns related to adverse effects:

• Anterograde amnesia: Benzodiazepines have been associated with anterograde amnesia (Nelson 1999).

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; effects may be potentiated by other CNS depressants, psychoactive medication, or ethanol. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Paradoxical reactions: Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines; risk may be increased in adolescent/pediatric patients, geriatric patients, or patients with a history of alcohol use disorder or psychiatric/personality disorders (Mancuso 2004).

• Sleep-related activities: Hazardous sleep-related activities such as sleep-driving, cooking and eating food, and making phone calls while asleep have been noted with benzodiazepines (Dolder 2008).

Disease-related concerns:

• Depression: Avoid use in patients with depression because of concerns about worsening mood symptoms, particularly if suicidal risk may be present, except for acute or emergency situations (eg, acute agitation, status epilepticus) (Craske 2022).

• Hepatic impairment: Use with caution in patients with mild or moderate hepatic impairment; dose adjustment may be necessary. Use is contraindicated in severe hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment; dose adjustment may be necessary.

• Respiratory disease: May cause respiratory depression; use with caution particularly in patients with preexisting or chronic respiratory disease and concomitantly with other respiratory depressive agents. Use is contraindicated with severe disease.

Special populations:

• Debilitated patients: Use with caution in debilitated patients; may experience greater adverse effects. Limit dose to smallest effective amount and increase gradually and as tolerated to avoid adverse reactions.

• Older adult patients: Use with caution in older adults; may experience greater adverse effects. Limit dose to smallest effective amount and increase gradually and as tolerated to avoid adverse reactions. Older adult patients may be at an increased risk of death with use; risk has been found highest within the first 4 months of use in older adult dementia patients (Jennum 2015; Saarelainen 2018).

• Fall risk: Use with extreme caution in patients who are at risk of falls (elderly); benzodiazepines have been associated with falls and traumatic injury (Nelson 1999).

Dosage form specific issues:

• Lactose: May contain lactose; do not use with galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption syndromes.

Concurrent drug therapy issues:

• Concomitant use with opioids: In patients already receiving an opioid analgesic, prescribe a lower initial dose of bromazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking bromazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Other warnings/precautions:

• Abuse, misuse, and substance use disorder: Counsel patients at increased risk on proper use and monitoring for signs and symptoms of abuse, misuse, and substance use disorder. Institute early treatment or refer patients in whom substance use disorder is suspected. Limit dosages and durations to the minimum required.

• Appropriate use: Does not have analgesic, antidepressant, or antipsychotic properties.

• Withdrawal: Withdrawal symptoms can occur hours to weeks after drug discontinuation and can occur when dose is tapered; symptoms can last for months. A longer sleep-onset latency and increased awakenings during sleep may occur for 1 to 2 days following the discontinuation of gamma aminobutyric acid (GABA)-mediated (GABAergic) medications. A more severe withdrawal syndrome may rarely occur following abrupt discontinuation or large decreases in dose after sustained use (>10 days), and is characterized by new-onset agitation, ataxia, depersonalization, dizziness, dysphoria, fatigue, headache, hypersensitivity to stimuli, irritability, muscle cramps or pain, nausea, sweating, twitching, vomiting, and weakness. This withdrawal syndrome generally resolves within weeks or upon reinitiation of the GABAergic medication. Intermittent dosing may reduce the risk of withdrawal symptoms (BAP [Wilson 2019]).

Product Availability

Not available in the United States.

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 1.5 mg, 3 mg, 6 mg

Administration: Adult

May be administered with or without food.

Use: Labeled Indications

Note: Not approved in the United States.

Anxiety: Short-term, symptomatic treatment of severe anxiety

Medication Safety Issues

Older Adult: High-Risk Medication:

Beers Criteria: Benzodiazepines (bromazepam) are identified in the Beers Criteria as potentially inappropriate medications to be avoided in patients 65 years and older due to risk of abuse, misuse, physical dependence and addiction. In addition, older adults have increased risk of impaired cognition, delirium, falls, fractures, and motor vehicle accidents with benzodiazepine use. However, benzodiazepine use may be appropriate in the elderly when used for seizure disorders, rapid eye movement sleep behavior disorders, benzodiazepine or ethanol withdrawal, severe generalized anxiety disorder, or periprocedural anesthesia (Beers Criteria [AGS 2023]).

International issues:

Lexotan [multiple international markets] may be confused with Loxitane brand name for loxapine [U.S.]

Metabolism/Transport Effects

Substrate of CYP1A2 (Major with inhibitors), CYP1A2 (Minor with inducers); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Acrivastine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Alcohol (Ethyl): CNS Depressants may increase CNS depressant effects of Alcohol (Ethyl). Risk C: Monitor

Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

ARIPiprazole Lauroxil: May increase CNS depressant effects of Benzodiazepines. ARIPiprazole Lauroxil may increase hypotensive effects of Benzodiazepines. Specifically, the risk of orthostatic hypotension may be increased. Risk C: Monitor

ARIPiprazole: May increase CNS depressant effects of Benzodiazepines. ARIPiprazole may increase hypotensive effects of Benzodiazepines. Specifically, orthostatic hypotension may be increased. Risk C: Monitor

Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification

Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Beta-Acetyldigoxin: Benzodiazepines may increase serum concentration of Beta-Acetyldigoxin. Risk C: Monitor

Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification

Brexanolone: CNS Depressants may increase CNS depressant effects of Brexanolone. Risk C: Monitor

Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification

BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor

Certoparin: May increase serum concentration of Benzodiazepines. Risk C: Monitor

Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification

Chloral Hydrate/Chloral Betaine: CNS Depressants may increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification

Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification

Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Cimetidine: May increase serum concentration of Bromazepam. Risk C: Monitor

CloZAPine: Benzodiazepines may increase adverse/toxic effects of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. Monitor for respiratory depression, hypotension, and other toxicities if these agents are combined. Risk D: Consider Therapy Modification

CNS Depressants: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Corticosteroids (Orally Inhaled): Benzodiazepines may increase adverse/toxic effects of Corticosteroids (Orally Inhaled). Specifically, the risk of pneumonia may be increased. Risk C: Monitor

CYP1A2 Inhibitors (Strong): May increase serum concentration of Bromazepam. Risk C: Monitor

Dantrolene: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Daridorexant: May increase CNS depressant effects of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification

Diazoxide Choline: May increase serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk X: Avoid

Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Difenoxin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor

Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Doxylamine: CNS Depressants may increase CNS depressant effects of Doxylamine. Risk C: Monitor

DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification

Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor

Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Esketamine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid

Flunitrazepam: CNS Depressants may increase CNS depressant effects of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider Therapy Modification

HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification

Ilaprazole: May increase serum concentration of Benzodiazepines. Risk C: Monitor

Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Lemborexant: May increase CNS depressant effects of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider Therapy Modification

Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofepramine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification

Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Melatonin: May increase sedative effects of Benzodiazepines. Risk C: Monitor

Melitracen [INT]: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Methadone: Benzodiazepines may increase CNS depressant effects of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. Risk D: Consider Therapy Modification

Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification

Methoxyflurane: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor

Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Nalfurafine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid

OLANZapine: Benzodiazepines may increase adverse/toxic effects of OLANZapine. Management: Monitor closely for hypotension, respiratory or central nervous system depression, and bradycardia if olanzapine is combined with benzodiazepines. Use of parenteral benzodiazepines with IM olanzapine is not recommended. Risk C: Monitor

Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid

Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Oxybate Salt Products: Benzodiazepines may increase CNS depressant effects of Oxybate Salt Products. Risk X: Avoid

OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Paliperidone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid

Perampanel: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor

Pizotifen: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor

Primaquine: May increase serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor

Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification

ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor

Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor

Suvorexant: CNS Depressants may increase CNS depressant effects of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Teduglutide: May increase serum concentration of Benzodiazepines. Risk C: Monitor

Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid

Theophylline Derivatives: May decrease therapeutic effects of Benzodiazepines. Risk C: Monitor

Trimeprazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Yohimbine: May decrease therapeutic effects of Antianxiety Agents. Risk C: Monitor

Zolpidem: CNS Depressants may increase CNS depressant effects of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider Therapy Modification

Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification

Reproductive Considerations

Bromazepam is not a first-line medication to treat anxiety disorders prior to conception in patients who are treatment naive or who do not have a history of effective treatment with a specific medication. Patients effectively treated may continue their current medication when planning a pregnancy unless contraindications exist. Management of mental health conditions in patients who could become pregnant should be based on a shared decision-making process that considers the possibility of pregnancy during treatment (ACOG 2023, BAP [McAllister-Williams 2017]).

Pregnancy Considerations

In utero exposure to benzodiazepines has the potential to cause harm to the fetus. Teratogenic effects have been observed in some studies; however, a clear association has not been reported and additional data are needed (Bellantuono 2013; Chuang 2024; Freeman 2018; Grigoriadis 2019; Tinker 2019; Wu 2024). Exposure to a benzodiazepine late in pregnancy may cause neonatal sedation (hypotonia, lethargy, respiratory depression) and/or symptoms of neonatal withdrawal (feeding difficulties, hyperreflexia, inconsolable crying, irritability, restlessness, tremors) (Iqbal 2002). Monitor newborns exposed to bromazepam in utero for adverse events. Data related to long-term effects on neurodevelopment following maternal use of benzodiazepines are inconclusive (Andrade 2024; Radojčić 2017; Sundbakk 2025; Wang 2022).

Untreated and undertreated mental health conditions are associated with adverse pregnancy outcomes. Anxiety disorders during pregnancy are associated with low birth weight, preterm birth, and adverse behavioral outcomes in the offspring. Discontinuing effective medications during pregnancy increases the risk of relapse. Management should be made as part of a shared decision-making process. Agents other than bromazepam may be preferred when treatment for anxiety is initiated for the first time during pregnancy. The use of benzodiazepines for the treatment of perinatal anxiety should be avoided or used sparingly until preferred therapy is initiated and effective, or when preferred therapy is not effective. When medications are used, the lowest effective dose of a single agent is recommended. Optimize dosing prior to changing a medication or adding additional agents whenever possible. Monthly monitoring for symptom improvement with a validated screening tool during pregnancy is recommended. Manage side effects as needed (ACOG 2023).

Breastfeeding Considerations

Bromazepam and metabolites are expected to be present in breast milk.

Drowsiness, lethargy, or weight loss in breastfeeding infants have been observed in case reports following maternal use of some benzodiazepines (Iqbal 2002).

Breastfeeding during bromazepam therapy is not recommended by the manufacturer.

Monitoring Parameters

Respiratory, cardiovascular (heart rate, BP), periodic CBC, renal and LFTs.

Mechanism of Action

Intermediate-acting benzodiazepine (based on half-life) (Griffin 2013). Benzodiazepines bind to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization. Benzodiazepine receptors and effects appear to be linked to the GABA-A receptors. Benzodiazepines do not bind to GABA-B receptors (Brunton, 2011).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Rapid (Kaplan 1976). Food may significantly decrease absorption (decreased C_max and AUC). Time to peak and half-life do not appear to be affected (Fujii 1990).

Duration of action: Classified as an intermediate-acting benzodiazepine; classification based on benzodiazepines with half-life of 12 to 40 hours (Griffin 2013).

Distribution: V_d: ~50 L.

Protein binding: 70%.

Metabolism: Hepatic via hydroxylation and glucuronidation; active metabolite 3-hydroxybromazepam (Greenblatt 1981).

Bioavailability: 60%.

Half-life elimination: 20 hours (may be prolonged in the elderly).

Time to peak, serum: ≤2 hours

Excretion: Urine (69% as metabolites 3-hydroxybromazepam and 2-[2-amino-5-bromo-3-hydroxybenzoyl]-pyridine)

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Lexotanil;
(AR) Argentina: 9nyl | Atemperator | Benedorm | Bromatanil | Bromazepam temis | Bromazepan vannier | Creosedin | Equisedin | Estomina | Fabozepam | Fada bromazepam | Finaten | Lexotanil | Neurozepam | Nulastres | Octanyl | Quietan | Sedatus | Sipcar | Tritopan | Trump;
(AT) Austria: Bromazepam genericon pharma | Lexotanil;
(AU) Australia: Lexotan;
(BD) Bangladesh: Anxionil | Anxirel | Anxopam | Bopam | Bromazep | Bronium | Broze | Freten | Kpam | Laxonil | Laxyl | Lexopil | Lexotanil | Mapez | Nightus | Norry | Notens | Rem | Restol | Siesta | Tenapam | Tenil | Tensfree | Xionil | Xiopam | Zepam | Zerotens;
(BE) Belgium: Anxiocalm | Bromatop | Bromazemed | Bromazepam eurogenerics | Bromazepam Ratiopharm | Bromazepam Sandoz | Bromazepam teva generics belgium | Bromidem | Docbromaze | Lexotan;
(BG) Bulgaria: Lekotam | Lexaurin | Lexotan | Lexotanil;
(BR) Brazil: Bromalex | Bromazepan | Bromoxon | Brozepax | Fluxtar | Lexfast | Lexotan | Lezepan | Nervium | Neurilan | Novazepam | Relaxil | Somalium | Uni bromazepax;
(CH) Switzerland: Bromazepam skyepharma | Lexotanil;
(CI) Côte d'Ivoire: Anxiomyl | Bromalex;
(CL) Chile: Lexotanil | Totasedan;
(CO) Colombia: Ansiosel | Bromazepan | Lexotan | Octanyl;
(CZ) Czech Republic: Bromazepam medreg | Lexaurin | Lexotanil;
(DE) Germany: Bromalich | Bromazanil | Bromazep | Bromazepam 6 1a pharma | Bromazepam al | Bromazepam Billix | Bromazepam Dura | Durazanil | Gityl | Lexostad | Lexotan 6 | Lexotanil | Lexotanil 6 | Neo OPT | Normoc;
(DO) Dominican Republic: Ansiogen | Bromazepan | Lexotan | Lortan | Octanyl;
(EC) Ecuador: Katalem | Lexotan | Octanyl;
(EE) Estonia: Lexotan | Lexotanil;
(EG) Egypt: Bromazanil | Bropam | Calmepam | Calmetanil | Lexopam | Lexotanil | Neo OPT;
(ET) Ethiopia: Lexotan;
(FR) France: Anxyrex | Bromazepam arrow | Bromazepam biogaran | Bromazepam cristers | Bromazepam g gam | Bromazepam gnr | Bromazepam irex | Bromazepam Isomed | Bromazepam ivax | Bromazepam merck | Bromazepam Qualimed | Bromazepam Ratiopharm | Bromazepam rpg | Bromazepam Sandoz | Bromazepam teva | Bromazepam zydus | Lexomil | Quietiline;
(GB) United Kingdom: Lexotan;
(GR) Greece: Anconevron | Evagelin | Lexotanil | Libronil r | Notorium | Pascalium;
(HK) Hong Kong: Akamon | Lexilium | Lexotan;
(HR) Croatia: Lekotam | Lexaurin | Lexilium;
(ID) Indonesia: Lexotan | Lexzepam;
(IE) Ireland: Lexotan;
(IL) Israel: Lenitin;
(IT) Italy: Brixopan | Bromazepam almus | Bromazepam doc | Bromazepam eg | Bromazepam merck | Bromazepam sigma tau | Bromazepam Winthrop | Bromazepam zentiva | Lexotan;
(JO) Jordan: Akamon | Lexopam | Lexotanil | Novepam;
(JP) Japan: Lexotan | Seniran | Seniran aventis | Seniran hexal;
(KE) Kenya: Calmepam | Lexotanil | Nightus | Pascalium;
(KR) Korea, Republic of: Bropam | Lectopam | Myungin bromazepam;
(KW) Kuwait: Lexotanil;
(LB) Lebanon: Anxyl | Anxyrex | Apo bromazepam | Lexane;
(LT) Lithuania: Evagelin | Lekotam | Lexaurin | Lexilium | Lexotan | Lexotanil;
(LU) Luxembourg: Bromidem | Lexotan;
(LV) Latvia: Bromazanil | Bromazepam ct | Evagelin | Lekotam | Lexaurin | Lexilium | Lexotan | Lexotanil;
(MA) Morocco: Anxiol | Lexomil | Zepam;
(MX) Mexico: Apobran | Blameno | Otedram | Pisafrata;
(MY) Malaysia: Akamon | Bromazanil | Lexotan;
(NG) Nigeria: Juxotan | Talen;
(NL) Netherlands: Bromazepam Actavis | Bromazepam Ratiopharm | Lexotanil;
(NO) Norway: Bromam | Bromazepam Ratiopharm;
(PE) Peru: Ansietyl | Ansium | Bromazepan | Bronpamed | Dipax | Lexotan | Sedamax | Totasedan;
(PH) Philippines: Lexotan;
(PK) Pakistan: Adonil | Amaze | Amzee | Anxit | Anxolite | Anxoten | Anzonil | Arbro | Brexotanil | Brolite | Broma | Bromalex | Bromamed | Bropam | Broxonil | Brozinil | Calmease | Cope | Durazanil | Freedom | Hapro | Lexapam | Lexgit | Lexilium | Lexotanil | Lorival | Mazimax | Niquil | Pazam | Rekotnil | Relaxital | Romaiz | Romelex | Sakoon | Sambro | Sedonil | Serenex | Sonaril | T quil | Tensium | Tensonil | Tojina | Utanil | Xytinil;
(PL) Poland: Lexomil | Lexotan | Lexotanil | Sedam;
(PT) Portugal: Bromalex | Lexotan | Ultramidol;
(PY) Paraguay: Aneurit | Bromar | Bromazepam fapasa | Glorius | Lexotan | Mitransil | Nerfanil | Normazepan | Psicobrom | Sedazin | Sedopan | Solpan | Tredum;
(QA) Qatar: Lexotanil;
(RO) Romania: Bromazepam arena | Bromazepam lph | Bromazepam slavia | Calmepam | Lexaurin | Lexotan | Lexotanil;
(RU) Russian Federation: Bromazepam lannacher | Lexotan;
(SA) Saudi Arabia: Lexotanil;
(SG) Singapore: Lexotan;
(SI) Slovenia: Lekotam | Lexaurin | Lexilium;
(SK) Slovakia: Akamon | Bromazepam medopharm | Bromazepam medreg | Lexaurin;
(SR) Suriname: Bromazepam Actavis;
(TH) Thailand: Lexotan;
(TN) Tunisia: Bromazepam merck | Lexomil;
(TR) Turkey: Lexotanil;
(TW) Taiwan: Akamon | Benzu | Bromazin | Bropan | Culium | Lexotan | Lotan | Selitan;
(UY) Uruguay: Brasalen | Bropan | Creosedin | Duxil | Emopax | Equiplen | Equisedin | Lexotan | Lucita | Lusipax | Octanyl;
(VE) Venezuela, Bolivarian Republic of: Bromased | Bromazepan | Bropax | Lexotanil | Nervan;
(ZA) South Africa: Brazepam | Bromaze | Lexotan | Rolab-bromazepam;
(ZM) Zambia: Bromaze;
(ZW) Zimbabwe: Apo bromazepam | Lexotanil | Sandoz bromazepam

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Topic 8697 Version 289.0

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Bromazepam (United States: Not available): Drug information