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Bromazepam (United States: Not available): Drug information

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 used in Lexicomp (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 worsen symptoms (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: Hepatic 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

May be product dependent

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); 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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect 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 enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect 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

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect 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 enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

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

CloZAPine: Benzodiazepines may enhance the adverse/toxic effect 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 enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Bromazepam. Risk C: Monitor therapy

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

Daridorexant: May enhance the CNS depressant effect 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 enhance the CNS depressant effect 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

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: CNS Depressants may enhance the CNS depressant effect of Doxylamine. Risk C: Monitor therapy

DroPERidol: May enhance the CNS depressant effect 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

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect 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 enhance the CNS depressant effect 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 the serum concentration of Benzodiazepines. Risk C: Monitor therapy

Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lemborexant: May enhance the CNS depressant effect 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

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Melatonin: May enhance the sedative effect of Benzodiazepines. Risk C: Monitor therapy

Methadone: Benzodiazepines may enhance the CNS depressant effect 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 enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect 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

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OLANZapine: Benzodiazepines may enhance the adverse/toxic effect 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 therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect 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

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Oxybate Salt Products: Benzodiazepines may enhance the CNS depressant effect of Oxybate Salt Products. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect 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

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect 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 enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Suvorexant: CNS Depressants may enhance the CNS depressant effect 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 the serum concentration of Benzodiazepines. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Theophylline Derivatives: May diminish the therapeutic effect of Benzodiazepines. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect 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 enhance the CNS depressant effect 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

Therapy for anxiety should be individualized (BAP [McAllister-Williams 2017]); avoid the use of benzodiazepines for the treatment of anxiety disorders in patients planning to become pregnant (Larsen 2015).

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; Freeman 2018; Grigoriadis 2019; Noh 2022; Szpunar 2022; Tinker 2019; Wikner 2007). 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). Data related to long-term effects on neurodevelopment are inconclusive (Chen 2022; Radojčić 2017; Sundbakk 2022; Wang 2022). Newborns exposed to benzodiazepines in utero should be monitored for feeding problems, respiratory depression, sedation, and withdrawal.

Therapy for anxiety during pregnancy should be individualized. Untreated or inadequately treated psychiatric illness may lead to poor adherence to prenatal care and adverse pregnancy outcomes (ACOG 2008). Benzodiazepines are not preferred when pharmacologic treatment for anxiety disorders is needed during pregnancy (BAP [McAllister-Williams 2017]; Larsen 2015). If possible, avoid scheduled doses of benzodiazepines in the month prior to delivery to reduce the risk of withdrawal symptoms in the newborn (Larsen 2015).

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 benzodiazepine therapy is not recommended due to the potential for drowsiness in the breastfeeding infant (Larsen 2015); 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: Food may significantly decrease absorption (decreased Cmax 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: Vd: ~50 L

Protein binding: 70%

Metabolism: Hepatic via hydroxylation and glucuronidation

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 | Lexotan | 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 | 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;
  • (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 | Lexotanil | Nervan;
  • (ZA) South Africa: Brazepam | Bromaze | Lexotan | Rolab-bromazepam;
  • (ZM) Zambia: Bromaze;
  • (ZW) Zimbabwe: Apo bromazepam | Lexotanil | Sandoz bromazepam
  1. 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. doi:10.1111/jgs.18372 [PubMed 37139824]
  2. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008;111(4):1001-1020. doi:10.1097/AOG.0b013e31816fd910 [PubMed 18378767]
  3. APO-bromazepam (bromazepam) [product monograph]. Toronto, Ontario, Canada: Apotex Inc; October 2022.
  4. Bandelow B, Allgulander C, Baldwin DS, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for treatment of anxiety, obsessive-compulsive and posttraumatic stress disorders - version 3. Part I: anxiety disorders. World J Biol Psychiatry. 2023;24(2):79-117. doi:10.1080/15622975.2022.2086295 [PubMed 35900161]
  5. Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry. 2013;35(1):3-8. doi:10.1016/j.genhosppsych.2012.09.003 [PubMed 23044244]
  6. Bromazepam [product monograph]. Toronto, Ontario, Canada: Teva Canada Limited; July 2021.
  7. Brunton LL, Chabner BA, Knollmann BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill Medical; 2011.
  8. Chen VC, Wu SI, Lin CF, Lu ML, Chen YL, Stewart R. Association of prenatal exposure to benzodiazepines with development of autism spectrum and attention-deficit/hyperactivity disorders. JAMA Netw Open. 2022;5(11):e2243282. doi:10.1001/jamanetworkopen.2022.43282 [PubMed 36413366]
  9. Craske M, Bystritsky A. Generalized anxiety disorder in adults: Management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed January 19. 2022.
  10. Dolder CR, Nelson MH. Hypnosedative-induced complex behaviours: incidence, mechanisms and management. CNS Drugs. 2008;22(12):1021-1036. [PubMed 18998740]
  11. Freeman MP, Góez-Mogollón L, McInerney KA, et al. Obstetrical and neonatal outcomes after benzodiazepine exposure during pregnancy: results from a prospective registry of women with psychiatric disorders. Gen Hosp Psychiatry. 2018;53:73-79. doi:10.1016/j.genhosppsych.2018.05.010 [PubMed 29958100]
  12. Fujii J, Inotsume N, Nakano M. Effect of Food on the Bioavailability of Bromazepam Following Oral Administration in Healthy Volunteers. J Pharmacobiodyn. 1990;13(5):269-271. [PubMed 2273442]
  13. Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013;13(2):214-223. [PubMed 23789008]
  14. Grigoriadis S, Graves L, Peer M, et al. Benzodiazepine use during pregnancy alone or in combination with an antidepressant and congenital malformations: systematic review and meta-analysis. J Clin Psychiatry. 2019;80(4):18r12412. doi:10.4088/JCP.18r12412 [PubMed 31294935]
  15. Iqbal MM, Sobhan T, Ryals T. Effects of Commonly Used Benzodiazepines on the Fetus, the Neonate, and the Nursing Infant. Psychiatr Serv. 2002;53(1):39-49. [PubMed 11773648]
  16. Jennum P, Baandrup L, Ibsen R, et al. Increased all-cause mortality with use of psychotropic medication in dementia patients and controls: A population-based register study. Eur Neuropsychopharmacol. 2015;25(11):1906-1913. doi: 10.1016/j.euroneuro.2015.08.014. [PubMed 26342397]
  17. Katzman MA, Bleau P, Blier P, et al. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. BMC Psychiatry. 2014;14(suppl 1):S1. doi:10.1186/1471-244X-14-S1-S1 [PubMed 25081580]
  18. Lader M. Benzodiazepines revisited--will we ever learn? Addiction. 2011;106(12):2086-2109. doi:10.1111/j.1360-0443.2011.03563.x [PubMed 21714826]
  19. Larsen ER, Damkier P, Pedersen LH, et al; Danish Psychiatric Society; Danish Society of Obstetrics and Gynecology; Danish Paediatric Society; Danish Society of Clinical Pharmacology. Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl. 2015;(445):1-28. doi:10.1111/acps.12479 [PubMed 26344706]
  20. Lectopam (bromazepam) [product monograph]. Mississauga, Ontario, Canada: Hoffman-La Roche Limited; September 2018.
  21. Lexotan (bromazepam) [product information]. Dee Why NSW, Australia: Roche Products PTY Limited; October 2012.
  22. Mancuso CE, Tanzi MG, Gabay M. Paradoxical reactions to benzodiazepines: literature review and treatment options. Pharmacotherapy. 2004;24(9):1177-1185. [PubMed 15460178]
  23. McAllister-Williams RH, Baldwin DS, Cantwell R, et al; endorsed by the British Association for Psychopharmacology. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017;31(5):519-552. doi:10.1177/0269881117699361 [PubMed 28440103]
  24. Nelson J, Chouinard G. Guidelines for the clinical use of benzodiazepines: pharmacokinetics, dependency, rebound, and withdrawal. Canadian Society for Clinical Pharmacology. Can J Clin Pharmacol. 1999;6(2):69-83. [PubMed 10519733]
  25. Noh Y, Lee H, Choi A, et al. First-trimester exposure to benzodiazepines and risk of congenital malformations in offspring: a population-based cohort study in South Korea. PLoS Med. 2022;19(3):e1003945. doi:10.1371/journal.pmed.1003945 [PubMed 35235572]
  26. Park TW. Benzodiazepine use disorder. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 12, 2022.
  27. Radojčić MR, El Marroun H, Miljković B, et al. Prenatal exposure to anxiolytic and hypnotic medication in relation to behavioral problems in childhood: a population-based cohort study. Neurotoxicol Teratol. 2017;61:58-65. doi:10.1016/j.ntt.2017.02.005 [PubMed 28259732]
  28. Saarelainen L, Tolppanen AM, Koponen M, et al. Risk of death associated with new benzodiazepine use among persons with Alzheimer disease: A matched cohort study. Int J Geriatr Psychiatry. 2018;33(4):583-590. doi:10.1002/gps.4821 [PubMed 29143367]
  29. Sundbakk LM, Gran JM, Wood ME, Handal M, Skurtveit S, Nordeng H. Association of prenatal exposure to benzodiazepines and Z-hypnotics with risk of attention-deficit/hyperactivity disorder in childhood. JAMA Netw Open. 2022;5(12):e2246889. doi:10.1001/jamanetworkopen.2022.46889 [PubMed 36520439]
  30. Szpunar MJ, Freeman MP, Kobylski LA, et al. Risk of major malformations in infants after first-trimester exposure to benzodiazepines: results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. Depress Anxiety. 2022;39(12):751-759. doi:10.1002/da.23280 [PubMed 35909254]
  31. Tinker SC, Reefhuis J, Bitsko RH, et al; National Birth Defects Prevention Study. Use of benzodiazepine medications during pregnancy and potential risk for birth defects, National Birth Defects Prevention Study, 1997-2011. Birth Defects Res. 2019;111(10):613-620. doi:10.1002/bdr2.1497 [PubMed 30891943]
  32. US Department of Veterans Affairs/Department of Defense (VA/DoD). VA/DoD clinical practice guideline for the management of posttraumatic stress disorder and acute stress disorder. https://www.healthquality.va.gov/guidelines/MH/ptsd/VADoDPTSDCPGFinal.pdf. Updated June 2017. Accessed March 9, 2020.
  33. US Department of Veterans Affairs/US Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. https://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPG.pdf. Published August 2021. Accessed May 12, 2022.
  34. Wang X, Zhang T, Ekheden I, et al. Prenatal exposure to benzodiazepines and Z-drugs in humans and risk of adverse neurodevelopmental outcomes in offspring: a systematic review. Neurosci Biobehav Rev. 2022;137:104647. doi:10.1016/j.neubiorev.2022.104647 [PubMed 35367514]
  35. Wikner BN, Stiller CO, Bergman U, et al. Use of Benzodiazepines and Benzodiazepine Receptor Agonists During Pregnancy: Neonatal Outcome and Congenital Malformations. Pharmacoepidemiol Drug Saf. 2007;16(11):1203-1210. [PubMed 17894421]
  36. Wilson S, Anderson K, Baldwin D, et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. J Psychopharmacol. 2019;33(8):923-947. doi:10.1177/0269881119855343 [PubMed 31271339]
Topic 8697 Version 262.0

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