{"id":"bromazepam","rwe":[],"tags":[{"label":"bromazepam","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"GABA-A receptor alpha-1/beta-2/gamma-2","category":"target"},{"label":"GABRA1","category":"gene"},{"label":"GABRB2","category":"gene"},{"label":"GABRG2","category":"gene"},{"label":"N05BA08","category":"atc"},{"label":"Active","category":"status"},{"label":"Anti-Anxiety Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"GABA Agents","category":"pharmacology"},{"label":"GABA Modulators","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"},{"label":"Tranquilizing Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":1264.416,"date":"","count":647,"signal":"Coma","source":"DrugCentral FAERS","actionTaken":"Reported 647 times (LLR=1264)"},{"llr":1098.816,"date":"","count":675,"signal":"Drug abuse","source":"DrugCentral FAERS","actionTaken":"Reported 675 times (LLR=1099)"},{"llr":734.229,"date":"","count":263,"signal":"Poisoning deliberate","source":"DrugCentral FAERS","actionTaken":"Reported 263 times (LLR=734)"},{"llr":666.472,"date":"","count":286,"signal":"Sopor","source":"DrugCentral FAERS","actionTaken":"Reported 286 times (LLR=666)"},{"llr":514.335,"date":"","count":681,"signal":"Toxicity to various agents","source":"DrugCentral FAERS","actionTaken":"Reported 681 times (LLR=514)"},{"llr":467.502,"date":"","count":521,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 521 times (LLR=468)"},{"llr":407.386,"date":"","count":324,"signal":"Intentional overdose","source":"DrugCentral FAERS","actionTaken":"Reported 324 times (LLR=407)"},{"llr":344.797,"date":"","count":272,"signal":"Suicide attempt","source":"DrugCentral FAERS","actionTaken":"Reported 272 times (LLR=345)"},{"llr":282.417,"date":"","count":133,"signal":"Mydriasis","source":"DrugCentral FAERS","actionTaken":"Reported 133 times (LLR=282)"},{"llr":278.468,"date":"","count":180,"signal":"Drug dependence","source":"DrugCentral FAERS","actionTaken":"Reported 180 times (LLR=278)"},{"llr":237.172,"date":"","count":96,"signal":"Drug use disorder","source":"DrugCentral FAERS","actionTaken":"Reported 96 times (LLR=237)"},{"llr":235.752,"date":"","count":167,"signal":"Altered state of consciousness","source":"DrugCentral FAERS","actionTaken":"Reported 167 times (LLR=236)"},{"llr":228.562,"date":"","count":110,"signal":"Miosis","source":"DrugCentral FAERS","actionTaken":"Reported 110 times (LLR=229)"},{"llr":220.874,"date":"","count":122,"signal":"Hypothermia","source":"DrugCentral FAERS","actionTaken":"Reported 122 times (LLR=221)"},{"llr":213.519,"date":"","count":305,"signal":"Overdose","source":"DrugCentral FAERS","actionTaken":"Reported 305 times (LLR=214)"}],"commonSideEffects":[{"effect":"Coma","drugRate":"LLR 1264","severity":"serious"},{"effect":"Drug abuse","drugRate":"LLR 1099","severity":"serious"},{"effect":"Poisoning deliberate","drugRate":"LLR 734","severity":"serious"},{"effect":"Sopor","drugRate":"LLR 666","severity":"serious"},{"effect":"Toxicity to various agents","drugRate":"LLR 514","severity":"serious"},{"effect":"Somnolence","drugRate":"LLR 468","severity":"common"},{"effect":"Suicide attempt","drugRate":"LLR 345","severity":"common"},{"effect":"Mydriasis","drugRate":"LLR 282","severity":"common"},{"effect":"Drug dependence","drugRate":"LLR 278","severity":"common"},{"effect":"Drug use disorder","drugRate":"LLR 237","severity":"common"},{"effect":"Altered state of consciousness","drugRate":"LLR 236","severity":"common"},{"effect":"Miosis","drugRate":"LLR 229","severity":"common"},{"effect":"Hypothermia","drugRate":"LLR 221","severity":"common"},{"effect":"Overdose","drugRate":"LLR 214","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"durazanil","offLabel":[],"synonyms":["bromazepam","durazanil"],"timeline":[{"date":"1974-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"brandName":"Durazanil","ecosystem":[],"mechanism":{"target":"GABA-A receptor alpha-1/beta-2/gamma-2","targets":[{"gene":"GABRA1","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit alpha-1"},{"gene":"GABRB2","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit beta-2"},{"gene":"GABRG2","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit gamma-2"}],"modality":"Small Molecule","drugClass":"bromazepam","explanation":"Imagine your brain is like a busy city with lots of noise and activity. GABA is like a traffic cop that helps to slow down the traffic and keep things calm. Durazanil helps the traffic cop do its job more effectively, which can help to reduce anxiety and promote relaxation.","oneSentence":"Durazanil works by enhancing the activity of the neurotransmitter GABA, which helps to calm excessive brain activity.","technicalDetail":"Durazanil acts as a positive allosteric modulator of the GABA-A receptor, increasing the frequency of chloride channel opening and enhancing the inhibitory effects of GABA on neuronal excitability."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Bromazepam","title":"Bromazepam","extract":"Bromazepam, sold under many brand names, is a benzodiazepine. It is mainly an anti-anxiety agent with similar side effects to diazepam. In addition to being used to treat anxiety or panic states, bromazepam may be used as a premedicant prior to minor surgery. Bromazepam typically comes in doses of 1.5 mg, 3 mg and 6 mg tablets.","wiki_society_and_culture":"==Society and culture==\n\n===Drug misuse===\n\nBromazepam has a similar misuse risk as other benzodiazepines such as diazepam. In France car accidents involving psychotropic drugs in combination with alcohol (itself a major contributor) found benzodiazepines, mainly diazepam, nordiazepam, and bromazepam, to be the most common drug present in the blood stream, almost twice that of the next-most-common drug cannabis. Bromazepam has also been used in serious criminal offences including robbery, homicide, and sexual assault.\n\n===Brand names===\nIt is marketed under several brand names, including, Brozam, Lectopam, [https://edrug-online.com/342/lexomil-tablet.html Lexomil], Lexotan, Lexilium, Lexaurin, Brazepam, Rekotnil, Bromaze, Somalium, Lexatin, Calmepam, Zepam and Lexotanil.<!-- Do not add any more brand names to this list unless they are from English-speaking countries for this wikipedia english version of the bromazepam article. There are dozens upon dozens of brand names if all non-English-speaking countries are included. -->\n\n===Legal status===\nBromazepam is a Schedule IV drug under the Convention on Psychotropic Substances.\n\n===Synthesis===\n<div style=\"width:auto; overflow:scroll\">\nclass=skin-invert-image|thumb|center|700px|Bromazepam synthesis.\n</div>"},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/399","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BROMAZEPAM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BROMAZEPAM","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Bromazepam","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T09:02:34.812948","biosimilars":[],"competitors":[{"drugName":"diazepam","drugSlug":"diazepam","fdaApproval":"1963-11-15","patentExpiry":"Oct 16, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"chlordiazepoxide","drugSlug":"chlordiazepoxide","fdaApproval":"1960-02-24","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"oxazepam","drugSlug":"oxazepam","fdaApproval":"1965-06-04","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"clorazepate","drugSlug":"clorazepate","fdaApproval":"1972-06-23","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lorazepam","drugSlug":"lorazepam","fdaApproval":"1977-09-30","patentExpiry":"Jan 8, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"clobazam","drugSlug":"clobazam","fdaApproval":"2011-10-21","patentExpiry":"Sep 5, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prazepam","drugSlug":"prazepam","fdaApproval":"","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"alprazolam","drugSlug":"alprazolam","fdaApproval":"1981-10-16","genericCount":24,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"halazepam","drugSlug":"halazepam","fdaApproval":"1981-09-24","patentStatus":"Unknown","relationship":"same-class"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"bromazepam","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"diazepam","brandName":"diazepam","genericName":"diazepam","approvalYear":"1963","relationship":"same-class"},{"drugId":"chlordiazepoxide","brandName":"chlordiazepoxide","genericName":"chlordiazepoxide","approvalYear":"1960","relationship":"same-class"},{"drugId":"oxazepam","brandName":"oxazepam","genericName":"oxazepam","approvalYear":"1965","relationship":"same-class"},{"drugId":"clorazepate","brandName":"clorazepate","genericName":"clorazepate","approvalYear":"1972","relationship":"same-class"},{"drugId":"lorazepam","brandName":"lorazepam","genericName":"lorazepam","approvalYear":"1977","relationship":"same-class"},{"drugId":"clobazam","brandName":"clobazam","genericName":"clobazam","approvalYear":"2011","relationship":"same-class"},{"drugId":"prazepam","brandName":"prazepam","genericName":"prazepam","approvalYear":"","relationship":"same-class"},{"drugId":"alprazolam","brandName":"alprazolam","genericName":"alprazolam","approvalYear":"1981","relationship":"same-class"},{"drugId":"halazepam","brandName":"halazepam","genericName":"halazepam","approvalYear":"1981","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06993662","phase":"PHASE1","title":"The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rakitzi, Stavroula","startDate":"2025-06-02","conditions":["Anxiety","Depression","Obsessive-compulsive Disorder","Personality Disorder","Bipolar Disorder","Schizophrenia","Psychotic Disorders","PTSD"],"enrollment":107,"completionDate":"2027-12-20"},{"nctId":"NCT04410536","phase":"PHASE4","title":"Home Detox in Medication Overuse Headache (MOH) During Covid-19 Emergency","status":"COMPLETED","sponsor":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","startDate":"2020-06-15","conditions":["Migraine, Hemicrania"],"enrollment":25,"completionDate":"2022-07-31"},{"nctId":"NCT06463210","phase":"NA","title":"Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy","status":"COMPLETED","sponsor":"Hospital Universitario 12 de Octubre","startDate":"2022-01-01","conditions":["Pain, Acute","Satisfaction, Patient"],"enrollment":120,"completionDate":"2022-06-30"},{"nctId":"NCT02374567","phase":"PHASE3","title":"Pharmacovigilance in Gerontopsychiatric Patients","status":"TERMINATED","sponsor":"Hannover Medical School","startDate":"2015-01","conditions":["Dementia","Depression","Schizophrenia","Psychosomatic Disorders","Anxiety Disorders"],"enrollment":407,"completionDate":"2017-06-28"},{"nctId":"NCT01984931","phase":"PHASE3","title":"Study of Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)for Treatment of Post Operative Nausea and Vomiting","status":"UNKNOWN","sponsor":"CM Chungmu Hospital","startDate":"2013-10","conditions":["Nausea","Vomiting"],"enrollment":45,"completionDate":"2013-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"NUI":"N0000166922","MMSL":"11834","NDDF":"003512","UNII":"X015L14V0O","CHEBI":"CHEBI:31302","INN_ID":"2692","RXNORM":"1749","UMLSCUI":"C0006213","ChEMBL_ID":"CHEMBL277062","KEGG_DRUG":"D01245","DRUGBANK_ID":"DB01558","PUBCHEM_CID":"2441","SNOMEDCT_US":"387571009","MESH_DESCRIPTOR_UI":"D001960"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","halfLife":"21.0 hours","clearance":"0.51 mL/min/kg","bioavailability":"84%","fractionUnbound":"0.48%","volumeOfDistribution":"0.85 L/kg"},"publicationCount":562,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05BA08","allCodes":["N05BA08"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Durazanil, also known as bromazepam, is a small molecule drug that targets the GABA-A receptor alpha-1/beta-2/gamma-2 subunits. It is a benzodiazepine class medication, but its commercial status is unknown. Durazanil is not FDA-approved, and its approved indications are also unknown. The medication has a half-life of 21.0 hours and a bioavailability of 84%. Key safety considerations include its potential for dependence and abuse.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}