{"id":"diazepam-2mg-encapsulated-tab","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNING"],"drugInteractions":[{"drug":"Opioids","action":"Monitor","effect":"Increased risk of respiratory depression"},{"drug":"Phenothiazines","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Antipsychotics","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Anxiolytics/Sedatives","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Hypnotics","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Anticonvulsants","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Narcotic Analgesics","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Anesthetics","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Sedative Antihistamines","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Barbiturates","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"MAO Inhibitors","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Other Antidepressants","action":"Monitor","effect":"Potentiation of sedative effects"},{"drug":"Alcohol","action":"Avoid","effect":"Enhancement of sedative effect"},{"drug":"Antacids","action":"Monitor","effect":"Lower peak concentrations and slower rate of absorption"},{"drug":"Cimetidine","action":"Monitor","effect":"Increased and prolonged sedation"},{"drug":"Ketoconazole","action":"Monitor","effect":"Increased and prolonged sedation"},{"drug":"Fluvoxamine","action":"Monitor","effect":"Increased and prolonged sedation"},{"drug":"Fluoxetine","action":"Monitor","effect":"Increased and prolonged sedation"},{"drug":"Omeprazole","action":"Monitor","effect":"Increased and prolonged sedation"},{"drug":"Phenytoin","action":"Monitor","effect":"Decreased metabolic elimination of phenytoin"}],"commonSideEffects":[],"contraindications":["known hypersensitivity to diazepam","pediatric patients under 6 months of age","myasthenia gravis","severe respiratory insufficiency","severe hepatic insufficiency","sleep apnea syndrome","acute narrow-angle glaucoma"],"specialPopulations":{"Pregnancy":"Use of diazepam tablets late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to diazepam during pregnancy or labor for signs of sedation and monitor neonates exposed to diazepam during pregnancy for signs of withdrawal; manage.","Geriatric use":"In elderly patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially to be increased gradually as needed and tolerated). Extensive accumulation of diazepam and its major metabolite, desmethyldiazepam, has been noted following chronic administration of diazepam in healthy elderly male subjects. Metabolites of this drug are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.","Paediatric use":"Safety and effectiveness in pediatric patients below the age of 6 months have not been established.","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$267.2623/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$97,551","description":"DIAZEPAM 10 MG RECTAL GEL SYST","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Diazepam 2Mg encapsulated Tab","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:42:55.002340+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:43:02.871650+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:42:55.078132+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Diazepam 2Mg encapsulated Tab","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:43:03.463905+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: GABA-A receptor; anion channel positive allosteric modulator","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:43:04.960918+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL12/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:43:04.621283+00:00"}},"offLabel":[],"timeline":[{"date":"1963-01-01","type":"positive","milestone":"Discovery and Initial Development","regulator":"none"},{"date":"1964-06-01","type":"positive","milestone":"IND Submission","regulator":"FDA"},{"date":"1965-01-01","type":"positive","milestone":"Phase 1 Clinical Trials Start","regulator":"none"},{"date":"1966-03-01","type":"positive","milestone":"Phase 2 Clinical Trials Start","regulator":"none"},{"date":"1968-09-01","type":"positive","milestone":"Phase 3 Clinical Trials Start","regulator":"none"},{"date":"1970-05-01","type":"positive","milestone":"FDA Approval","regulator":"FDA"},{"date":"1971-12-01","type":"positive","milestone":"EMA Approval","regulator":"EMA"},{"date":"1980-01-01","type":"positive","milestone":"Label Expansion for Anxiety Disorders","regulator":"FDA"},{"date":"1990-01-01","type":"neutral","milestone":"Patent Expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"Diazepam 2mg is a benzodiazepine marketed by The University of Hong Kong for anxiety disorders, acute alcohol withdrawal, muscle spasm relief, and adjunctive seizure management. As an established pharmaceutical with one clinical trial and marketed status, it represents a mature, well-characterized therapeutic option. The drug's broad clinical utility across multiple indications reflects decades of clinical validation, though it faces modern competition from newer anxiolytics with improved safety profiles. Commercial significance remains stable within the benzodiazepine class, primarily driven by cost-effectiveness and physician familiarity rather than innovation. No revenue data or novel mechanism developments are reported, indicating this is a legacy formulation in routine clinical use.","ecosystem":[],"mechanism":{"target":"GABA-A receptor (allosteric modulator)","novelty":"me-too","modality":"small molecule","drugClass":"Benzodiazepine","explanation":"","oneSentence":"","technicalDetail":"Diazepam binds to the benzodiazepine recognition site on GABA-A receptors, which are pentameric chloride channels composed of alpha, beta, and gamma subunits. This allosteric modulation increases the probability of channel opening in response to GABA, enhancing inhibitory postsynaptic potentials. The drug exhibits high lipophilicity, enabling rapid CNS penetration, and undergoes hepatic metabolism to active metabolites including desmethyldiazepam, which contributes to prolonged clinical effects."},"_scrapedAt":"2026-03-28T00:32:44.919Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:43:06.389751+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Lorazepam","slug":"lorazepam","company":"Preferred Pharmaceuticals, Inc.","advantage":"Same class (Benzodiazepine [EPC])","genericName":"LORAZEPAM"},{"name":"Clonazepam","slug":"clonazepam","company":"REMEDYREPACK INC.","advantage":"Same class (Benzodiazepine [EPC])","genericName":"CLONAZEPAM"},{"name":"Diazepam","slug":"diazepam","company":"A-S Medication Solutions","advantage":"Same class (Benzodiazepine [EPC])","genericName":"DIAZEPAM"},{"name":"Alprazolam","slug":"alprazolam","company":"NuCare Pharmaceuticals,Inc.","advantage":"Same class (Benzodiazepine [EPC])","genericName":"ALPRAZOLAM"},{"name":"Oxazepam","slug":"oxazepam","company":"American Health Packaging","advantage":"Same class (Benzodiazepine [EPC])","genericName":"OXAZEPAM"},{"name":"Temazepam","slug":"temazepam","company":"Bryant Ranch Prepack","advantage":"Same class (Benzodiazepine [EPC])","genericName":"TEMAZEPAM"},{"name":"Clobazam","slug":"clobazam","company":"Ascend Laboratories, LLC","advantage":"Same class (Benzodiazepine [EPC])","genericName":"CLOBAZAM"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Management of anxiety disorders","regulator":"FDA"},{"name":"Short-term relief of symptoms of anxiety","regulator":"FDA"},{"name":"Symptomatic relief of acute alcohol withdrawal","regulator":"FDA"},{"name":"Relief of skeletal muscle spasm","regulator":"FDA"},{"name":"Adjunctive treatment in convulsive disorders","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03246620","phase":"PHASE4","title":"Oral Olanzapine Versus Haloperidol or Diazepam","status":"TERMINATED","sponsor":"The University of Hong Kong","startDate":"2017-09-01","conditions":"Acute Agitation, Behavioural Emergency","enrollment":12}],"_emaApprovals":[{"date":"","name":"Diazepam 2Mg encapsulated Tab","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[{"role":"Manufacturer","site":"A-S Medication Solutions","location":"","operator":"A-S Medication Solutions"}],"molecularData":{"oral":true,"chemblId":"CHEMBL12","moleculeType":"Small molecule","molecularWeight":"284.75"},"_patentsChecked":true,"_warningLetters":[{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL12"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"2023-present","companyName":"The University of Hong Kong","relationship":"Originator"}],"pharmacokinetics":{"source":"FDA clinical pharmacology","halfLife":"1 hour","bioavailability":""},"publicationCount":0,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"FDA openfda","atcCode":"","mechClass":"","pharmClass":"Benzodiazepine [EPC]"},"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Diazepam 2Mg encapsulated Tab","genericName":"Diazepam 2Mg encapsulated Tab","companyName":"The University of Hong Kong","companyId":"the-university-of-hong-kong","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:43:06.389751+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}