{"id":"chloral-hydrate","rwe":[{"pmid":"41664211","year":"2026","title":"A comprehensive systematic review and meta-analysis of the safety of procedural sedation in pediatric emergency rooms.","finding":"","journal":"Italian journal of pediatrics","studyType":"Clinical Study"},{"pmid":"41568412","year":"2026","title":"Impact of Anesthesia Strategy on Infant Pulmonary Function Test Quality and Duration.","finding":"","journal":"Pediatric pulmonology","studyType":"Clinical Study"},{"pmid":"41559442","year":"2026","title":"Immune effects of trichloroethylene: key findings of occupational hypersensitivity syndrome and its pathogenesis.","finding":"","journal":"Archives of toxicology","studyType":"Clinical Study"},{"pmid":"41519682","year":"2026","title":"Drug-Related Halitosis: A Narrative Review.","finding":"","journal":"International dental journal","studyType":"Clinical Study"},{"pmid":"41500619","year":"2026","title":"Midazolam oral solution for neonatal MRI: study protocol of a randomised controlled trial.","finding":"","journal":"BMJ open","studyType":"Clinical Study"}],"tags":[{"label":"chloral hydrate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N05CC01","category":"atc"},{"label":"Active","category":"status"},{"label":"General anesthesia","category":"indication"},{"label":"Insomnia","category":"indication"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Hypnotics and Sedatives","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":562.356,"date":"","count":111,"signal":"Hypomania","source":"DrugCentral FAERS","actionTaken":"Reported 111 times (LLR=562)"},{"llr":521.254,"date":"","count":110,"signal":"Jaundice cholestatic","source":"DrugCentral FAERS","actionTaken":"Reported 110 times (LLR=521)"},{"llr":489.815,"date":"","count":113,"signal":"Schizophrenia","source":"DrugCentral FAERS","actionTaken":"Reported 113 times (LLR=490)"},{"llr":369.148,"date":"","count":111,"signal":"Psychotic disorder","source":"DrugCentral FAERS","actionTaken":"Reported 111 times (LLR=369)"},{"llr":346.51,"date":"","count":112,"signal":"Cholelithiasis","source":"DrugCentral FAERS","actionTaken":"Reported 112 times (LLR=347)"},{"llr":341.455,"date":"","count":111,"signal":"Hepatotoxicity","source":"DrugCentral FAERS","actionTaken":"Reported 111 times (LLR=341)"},{"llr":324.815,"date":"","count":111,"signal":"Blood bilirubin increased","source":"DrugCentral FAERS","actionTaken":"Reported 111 times (LLR=325)"},{"llr":208.913,"date":"","count":39,"signal":"Total lung capacity increased","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=209)"},{"llr":205.492,"date":"","count":115,"signal":"Hepatic enzyme increased","source":"DrugCentral FAERS","actionTaken":"Reported 115 times (LLR=205)"},{"llr":194.635,"date":"","count":39,"signal":"Asthma-chronic obstructive pulmonary disease overlap syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=195)"},{"llr":157.058,"date":"","count":39,"signal":"Nasal polyps","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=157)"},{"llr":149.738,"date":"","count":39,"signal":"Sarcoidosis","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=150)"},{"llr":140.974,"date":"","count":40,"signal":"Rhinitis allergic","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=141)"},{"llr":123.849,"date":"","count":40,"signal":"Cardiac murmur","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=124)"},{"llr":120.939,"date":"","count":119,"signal":"Condition aggravated","source":"DrugCentral FAERS","actionTaken":"Reported 119 times (LLR=121)"}],"drugInteractions":[{"url":"/drug/erythromycin","drug":"erythromycin","action":"Monitor closely","effect":"May interact with Erythromycin","source":"DrugCentral","drugSlug":"erythromycin"}],"commonSideEffects":[{"effect":"Hypomania","drugRate":"LLR 562","severity":"serious"},{"effect":"Jaundice cholestatic","drugRate":"LLR 521","severity":"serious"},{"effect":"Schizophrenia","drugRate":"LLR 490","severity":"common"},{"effect":"Psychotic disorder","drugRate":"LLR 369","severity":"common"},{"effect":"Cholelithiasis","drugRate":"LLR 347","severity":"common"},{"effect":"Hepatotoxicity","drugRate":"LLR 341","severity":"common"},{"effect":"Blood bilirubin increased","drugRate":"LLR 325","severity":"common"},{"effect":"Total lung capacity increased","drugRate":"LLR 209","severity":"common"},{"effect":"Hepatic enzyme increased","drugRate":"LLR 205","severity":"common"},{"effect":"Asthma-chronic obstructive pulmonary disease overlap syndrome","drugRate":"LLR 195","severity":"common"},{"effect":"Nasal polyps","drugRate":"LLR 157","severity":"common"},{"effect":"Sarcoidosis","drugRate":"LLR 150","severity":"common"},{"effect":"Rhinitis allergic","drugRate":"LLR 141","severity":"common"},{"effect":"Cardiac murmur","drugRate":"LLR 124","severity":"common"},{"effect":"Condition aggravated","drugRate":"LLR 121","severity":"common"}],"contraindications":["Acute disease of cardiovascular system","Acute intermittent porphyria","Acute nephropathy","Esophagitis","Gastritis","Hepatic failure","Inflammatory bowel disease","Peptic ulcer","Proctitis","Substance abuse"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"nycoton","offLabel":[],"synonyms":["chloral hydrate","chloraldurat","nycoton","phaldrone","trichloroacetaldehyde hydrate"],"timeline":[{"date":"1840-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"approvals":[{"date":"1840-01-01","orphan":false,"company":"","regulator":"YEAR INTRODUCED"}],"brandName":"Nycoton","ecosystem":[{"indication":"General anesthesia","otherDrugs":[{"name":"acetylcysteine","slug":"acetylcysteine","company":"Apothecon"},{"name":"alfentanil","slug":"alfentanil","company":"Akorn"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"amobarbital","slug":"amobarbital","company":""}],"globalPrevalence":null},{"indication":"Insomnia","otherDrugs":[{"name":"amobarbital","slug":"amobarbital","company":""},{"name":"choline","slug":"choline","company":""},{"name":"daridorexant","slug":"daridorexant","company":"Idorsia Pharmaceuticals Ltd"},{"name":"diphenhydramine","slug":"diphenhydramine","company":"Mcneil Cons"}],"globalPrevalence":750000000}],"mechanism":{"modality":"Small Molecule","drugClass":"chloral hydrate","explanation":"Imagine your brain is a busy city with lots of activity. Nycoton is like a traffic controller that slows down the flow of traffic, making it easier to fall asleep or relax. This is because it affects the way brain cells communicate with each other, leading to a decrease in activity and a sense of calm.","oneSentence":"Nycoton works by acting as a central nervous system depressant, slowing down brain activity to induce sleep or anesthesia.","technicalDetail":"Nycoton exerts its effects by inhibiting the activity of the enzyme glutathione S-transferase, which is involved in the metabolism of various neurotransmitters, leading to an increase in the levels of GABA, a major inhibitory neurotransmitter in the brain."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/586","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CHLORAL%20HYDRATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLORAL HYDRATE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T09:32:05.338736","biosimilars":[],"competitors":[],"genericName":"chloral hydrate","indications":{"approved":[{"name":"General anesthesia","source":"DrugCentral","snomedId":50697003,"regulator":"FDA"},{"name":"Insomnia","source":"DrugCentral","snomedId":193462001,"regulator":"FDA","usPrevalence":70000000,"globalPrevalence":750000000,"prevalenceMethod":"curated","prevalenceSource":"Sleep Medicine Reviews, 2023"}],"offLabel":[{"name":"Sedation","source":"DrugCentral","drugName":"CHLORAL HYDRATE","evidenceCount":618,"evidenceLevel":"strong"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06443632","phase":"NA","title":"WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy","status":"COMPLETED","sponsor":"Shandong Cancer Hospital and Institute","startDate":"2024-06-01","conditions":["Pediatric Cancer"],"enrollment":48,"completionDate":"2025-06-01"},{"nctId":"NCT06606899","phase":"NA","title":"A Comparison Between Oral Melatonin With Nasal Sevoflurane Versus Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Children Undergoing Brain MRI","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2024-09-20","conditions":["Sedation for Children Undergoing MRI"],"enrollment":60,"completionDate":"2024-12-30"},{"nctId":"NCT06053840","phase":"PHASE4","title":"An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia","status":"COMPLETED","sponsor":"Pharmanovia","startDate":"2023-09-01","conditions":["Insomnia","Insomnia Chronic","Chloral Hydrate"],"enrollment":100,"completionDate":"2024-05-07"},{"nctId":"NCT04820205","phase":"NA","title":"Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2021-10-29","conditions":["Sedation"],"enrollment":136,"completionDate":"2024-03-05"},{"nctId":"NCT06389318","phase":"NA","title":"Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair","status":"COMPLETED","sponsor":"Benha University","startDate":"2023-03-26","conditions":["Inguinal Hernia Repair"],"enrollment":80,"completionDate":"2024-04-24"},{"nctId":"NCT04822064","phase":"NA","title":"Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation","status":"UNKNOWN","sponsor":"Seoul National University Hospital","startDate":"2022-09-22","conditions":["Sedation"],"enrollment":70,"completionDate":"2025-12-31"},{"nctId":"NCT00881764","phase":"","title":"PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study","status":"COMPLETED","sponsor":"Columbia University","startDate":"2009-05","conditions":["Cognition - 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Disorders"],"enrollment":407,"completionDate":"2017-06-28"},{"nctId":"NCT02195661","phase":"PHASE3","title":"The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children","status":"COMPLETED","sponsor":"University of Cape Town","startDate":"2014-04","conditions":["Epilepsy","Electroencephalogram","Children","Sedation"],"enrollment":194,"completionDate":"2017-10"},{"nctId":"NCT03242629","phase":"NA","title":"Comparison Between Oral and Enema of Chloral Hydrate","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2017-01","conditions":["Congenital Cataract"],"enrollment":120,"completionDate":"2017-07"},{"nctId":"NCT02523144","phase":"PHASE4","title":"Dexmedetomidine in Children Having Transthoracic Echocardiography","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2014-09","conditions":["Heart Disease"],"enrollment":279,"completionDate":"2017-05"},{"nctId":"NCT02985567","phase":"","title":"An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2013-09","conditions":["Intraocular Pressure","Anesthesia"],"enrollment":324,"completionDate":"2016-11"},{"nctId":"NCT00464451","phase":"PHASE2","title":"Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG","status":"WITHDRAWN","sponsor":"Wesley Medical Center","startDate":"2009-08","conditions":["Procedural Sedation"],"enrollment":0,"completionDate":"2011-05"},{"nctId":"NCT01255904","phase":"PHASE4","title":"A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2011-08","conditions":["Sedation"],"enrollment":90,"completionDate":"2014-11"},{"nctId":"NCT02077712","phase":"NA","title":"Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2014-02","conditions":["Sniffs Drugs"],"enrollment":60,"completionDate":"2017-06"},{"nctId":"NCT02253199","phase":"PHASE4","title":"The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging","status":"COMPLETED","sponsor":"Guangzhou Women and Children's Medical Center","startDate":"2014-10","conditions":["Aged","Drug","Dose-Response Relationship"],"enrollment":120,"completionDate":"2016-03"},{"nctId":"NCT02239445","phase":"PHASE4","title":"Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging","status":"COMPLETED","sponsor":"Guangzhou Women and Children's Medical Center","startDate":"2014-09","conditions":["Administration Related Reaction","Failed Moderate Sedation During Procedure","Chloral Hydrate Adverse Reaction"],"enrollment":158,"completionDate":"2015-05"},{"nctId":"NCT01128270","phase":"PHASE1,PHASE2","title":"Pharmacotoxicology of Trichloroethylene Metabolites","status":"COMPLETED","sponsor":"University of Florida","startDate":"2010-04","conditions":["Healthy"],"enrollment":27,"completionDate":"2012-10"},{"nctId":"NCT01083797","phase":"PHASE3","title":"Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate","status":"COMPLETED","sponsor":"Federal University of Minas Gerais","startDate":"2009-12","conditions":["Other Conditions of Brain"],"enrollment":25,"completionDate":"2013-10"},{"nctId":"NCT01402596","phase":"PHASE2","title":"Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam","status":"WITHDRAWN","sponsor":"University of Sao Paulo","startDate":"2011-08","conditions":["Traumatic Brain Injury","Computed Tomography","Procedural Sedation"],"enrollment":0,"completionDate":"2012-08"},{"nctId":"NCT01149226","phase":"NA","title":"Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2010-05","conditions":["Pediatric"],"enrollment":100,"completionDate":"2010-12"},{"nctId":"NCT00949780","phase":"PHASE2","title":"Chloral Hydrate to Perform Auditory Brainstem Response (ABR)","status":"COMPLETED","sponsor":"Pontificia Universidade Catolica de Sao Paulo","startDate":"2007-10","conditions":["Auditory Brainstem Response in Children","Sedation With Chloral Hydrate"],"enrollment":41,"completionDate":"2008-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000146094","MMSL":"3870","NDDF":"001427","UNII":"418M5916WG","VUID":"4017726","CHEBI":"CHEBI:28142","VANDF":"4017726","RXNORM":"2344","UMLSCUI":"C0008161","ChEMBL_ID":"CHEMBL455917","KEGG_DRUG":"D00265","DRUGBANK_ID":"DB01563","PUBCHEM_CID":"2707","SNOMEDCT_US":"273948005","MESH_DESCRIPTOR_UI":"D002697"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":2805,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05CC01","allCodes":["N05CC01"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Feb 9","pmid":"41664211","title":"A comprehensive systematic review and meta-analysis of the safety of procedural sedation in pediatric emergency rooms.","journal":"Italian journal of pediatrics"},{"date":"2026 Jan","pmid":"41568412","title":"Impact of Anesthesia Strategy on Infant Pulmonary Function Test Quality and Duration.","journal":"Pediatric pulmonology"},{"date":"2026 Jan 21","pmid":"41559442","title":"Immune effects of trichloroethylene: key findings of occupational hypersensitivity syndrome and its pathogenesis.","journal":"Archives of toxicology"},{"date":"2026 Apr","pmid":"41519682","title":"Drug-Related Halitosis: A Narrative Review.","journal":"International dental journal"},{"date":"2026 Jan 6","pmid":"41500619","title":"Midazolam oral solution for neonatal MRI: study protocol of a randomised controlled trial.","journal":"BMJ open"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nycoton, also known as chloral hydrate, is a small molecule drug in the chloral hydrate class. It was originally developed by an unknown entity and its current owner is also unknown. Nycoton is used to treat general anesthesia and insomnia. The commercial status of Nycoton is unclear, but it is likely off-patent. Key safety considerations include its potential for dependence and abuse.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"OTHER","regulator":"YEAR INTRODUCED","status":"approved","approval_date":"1840-01-01T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""}],"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}