{"id":"lormetazepam","rwe":[{"pmid":"41614106","year":"2025","title":"Insomnia in seasonal affective disorder: considering the use of benzodiazepines with a focus on lormetazepam.","finding":"","journal":"Frontiers in psychiatry","studyType":"Clinical Study"},{"pmid":"41441329","year":"2025","title":"Benzodiazepine (BZD) Use and Patient Safety: Opportunities for Community Pharmacy Involvement in the Management of Drug Interactions.","finding":"","journal":"Pharmacy (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41430063","year":"2026","title":"Toward AI-Assisted Greener Chiral HPLC: Predicting Efficient Enantioseparation-Mobile Phase (EES-MP) Profiles for MP Selection─A Lux Cellulose-1 Case Study.","finding":"","journal":"Analytical chemistry","studyType":"Clinical Study"},{"pmid":"40750507","year":"2025","title":"A descriptive study of national trends in the dispensing of reimbursed hypnotics in France between 2012 and 2022.","finding":"","journal":"Sleep 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(LLR=746)"},{"llr":436.977,"date":"","count":152,"signal":"Poisoning deliberate","source":"DrugCentral FAERS","actionTaken":"Reported 152 times (LLR=437)"},{"llr":330.717,"date":"","count":162,"signal":"Drug dependence","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=331)"},{"llr":305.622,"date":"","count":137,"signal":"Sopor","source":"DrugCentral FAERS","actionTaken":"Reported 137 times (LLR=306)"},{"llr":299.294,"date":"","count":209,"signal":"Intentional overdose","source":"DrugCentral FAERS","actionTaken":"Reported 209 times (LLR=299)"},{"llr":296.715,"date":"","count":304,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 304 times (LLR=297)"},{"llr":270.408,"date":"","count":103,"signal":"Miosis","source":"DrugCentral FAERS","actionTaken":"Reported 103 times (LLR=270)"},{"llr":246.241,"date":"","count":344,"signal":"Toxicity to various agents","source":"DrugCentral FAERS","actionTaken":"Reported 344 times (LLR=246)"},{"llr":208.458,"date":"","count":156,"signal":"Suicide attempt","source":"DrugCentral FAERS","actionTaken":"Reported 156 times (LLR=208)"},{"llr":197.968,"date":"","count":310,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 310 times (LLR=198)"},{"llr":175.072,"date":"","count":107,"signal":"Serotonin syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 107 times (LLR=175)"},{"llr":173.633,"date":"","count":200,"signal":"Overdose","source":"DrugCentral FAERS","actionTaken":"Reported 200 times (LLR=174)"},{"llr":160.62,"date":"","count":37,"signal":"Prescription form tampering","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=161)"},{"llr":120.445,"date":"","count":119,"signal":"Rhabdomyolysis","source":"DrugCentral FAERS","actionTaken":"Reported 119 times (LLR=120)"}],"commonSideEffects":[{"effect":"Coma","drugRate":"LLR 905","severity":"serious"},{"effect":"Drug abuse","drugRate":"LLR 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120","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"methyllorazepam","offLabel":[],"synonyms":["lormetazepam","methyllorazepam","N-Methyllorazepam"],"timeline":[],"brandName":"Methyllorazepam","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"lormetazepam","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 calm things down. Lormetazepam helps GABA to do its job more effectively, making it easier to fall asleep and stay asleep.","oneSentence":"Lormetazepam works by enhancing the activity of a neurotransmitter called GABA, which helps to calm the brain and induce sleep.","technicalDetail":"Lormetazepam acts as a positive allosteric modulator of the GABA_A receptor, increasing the frequency of chloride channel opening and resulting in hyperpolarization of the neuronal membrane, which leads to sedative and anxiolytic effects."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1608","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LORMETAZEPAM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LORMETAZEPAM","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T02:46:39.201586","biosimilars":[],"competitors":[{"drugName":"flurazepam","drugSlug":"flurazepam","fdaApproval":"1970-04-07","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"estazolam","drugSlug":"estazolam","fdaApproval":"1990-12-26","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"triazolam","drugSlug":"triazolam","fdaApproval":"1982-11-15","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"temazepam","drugSlug":"temazepam","fdaApproval":"1981-02-27","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"midazolam","drugSlug":"midazolam","fdaApproval":"1985-12-20","patentExpiry":"Jun 20, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"quazepam","drugSlug":"quazepam","fdaApproval":"1985-12-27","patentExpiry":"Jun 3, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"remimazolam","drugSlug":"remimazolam","fdaApproval":"2020-07-02","patentExpiry":"Nov 7, 2031","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"lormetazepam","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"flurazepam","brandName":"flurazepam","genericName":"flurazepam","approvalYear":"1970","relationship":"same-class"},{"drugId":"estazolam","brandName":"estazolam","genericName":"estazolam","approvalYear":"1990","relationship":"same-class"},{"drugId":"triazolam","brandName":"triazolam","genericName":"triazolam","approvalYear":"1982","relationship":"same-class"},{"drugId":"temazepam","brandName":"temazepam","genericName":"temazepam","approvalYear":"1981","relationship":"same-class"},{"drugId":"midazolam","brandName":"midazolam","genericName":"midazolam","approvalYear":"1985","relationship":"same-class"},{"drugId":"quazepam","brandName":"quazepam","genericName":"quazepam","approvalYear":"1985","relationship":"same-class"},{"drugId":"remimazolam","brandName":"remimazolam","genericName":"remimazolam","approvalYear":"2020","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06473415","phase":"","title":"Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit","status":"RECRUITING","sponsor":"Charite University, Berlin, Germany","startDate":"2023-12-01","conditions":["Critical Illness","Delirium","Sleep Disorders, Circadian Rhythm"],"enrollment":50,"completionDate":"2024-12-31"},{"nctId":"NCT02022592","phase":"PHASE4","title":"Comparison of Lormetazepam and Midazolam Used as Sedatives for Patients That Require Intensive Care","status":"COMPLETED","sponsor":"Claudia Spies","startDate":"2014-07-17","conditions":["Sedation in Intensive Care Unit Patients"],"enrollment":84,"completionDate":"2020-03-12"},{"nctId":"NCT04408911","phase":"","title":"Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2006-01-01","conditions":["Critical Illness"],"enrollment":3314,"completionDate":"2018-12-31"},{"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":"NCT00679900","phase":"PHASE3","title":"Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties","status":"COMPLETED","sponsor":"Sanofi","startDate":"2008-04","conditions":["Sleep Initiation and Maintenance Disorders"],"enrollment":283,"completionDate":"2009-03"},{"nctId":"NCT00788515","phase":"PHASE3","title":"Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties","status":"TERMINATED","sponsor":"Sanofi","startDate":"2008-11","conditions":["Sleep Initiation and Maintenance Disorders"],"enrollment":33,"completionDate":"2009-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"004099","UNII":"GU56C842ZA","CHEBI":"CHEBI:52993","INN_ID":"4339","RXNORM":"28894","UMLSCUI":"C0065185","ChEMBL_ID":"CHEMBL399058","KEGG_DRUG":"D01657","DRUGBANK_ID":"DB13872","PUBCHEM_CID":"13314","SNOMEDCT_US":"387570005","IUPHAR_LIGAND_ID":"7553","MESH_SUPPLEMENTAL_RECORD_UI":"C023842"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","halfLife":"4.9 hours","clearance":"4.0 mL/min/kg","bioavailability":"75%","fractionUnbound":"0.12%","volumeOfDistribution":"1.6 L/kg"},"publicationCount":275,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05CD06","allCodes":["N05CD06"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025","pmid":"41614106","title":"Insomnia in seasonal affective disorder: considering the use of benzodiazepines with a focus on lormetazepam.","journal":"Frontiers in psychiatry"},{"date":"2025 Dec 11","pmid":"41441329","title":"Benzodiazepine (BZD) Use and Patient Safety: Opportunities for Community Pharmacy Involvement in the Management of Drug Interactions.","journal":"Pharmacy (Basel, Switzerland)"},{"date":"2026 Jan 13","pmid":"41430063","title":"Toward AI-Assisted Greener Chiral HPLC: Predicting Efficient Enantioseparation-Mobile Phase (EES-MP) Profiles for MP Selection─A Lux Cellulose-1 Case Study.","journal":"Analytical chemistry"},{"date":"2025 Oct","pmid":"40750507","title":"A descriptive study of national trends in the dispensing of reimbursed hypnotics in France between 2012 and 2022.","journal":"Sleep health"},{"date":"2025 Sep","pmid":"40635153","title":"Rhabdomyolysis After Risperidone Overdose in a Patient With Schizophrenia: A Case Report.","journal":"Neuropsychopharmacology reports"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lormetazepam, a small molecule belonging to the drug class of lormetazepam, is a benzodiazepine derivative. It is used to treat insomnia and other sleep disorders. The commercial status of lormetazepam is not explicitly stated, but it is likely available as a generic medication. Lormetazepam has a half-life of 4.9 hours and a bioavailability of 75%. Its exact target and approved indications are unknown.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}