{"id":"zopiclone","rwe":[],"tags":[{"label":"zopiclone","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"GABA A receptor alpha-5/beta-2/gamma-2","category":"target"},{"label":"GABRA5","category":"gene"},{"label":"GABRB2","category":"gene"},{"label":"GABRG2","category":"gene"},{"label":"N05CF01","category":"atc"},{"label":"Active","category":"status"},{"label":"Insomnia","category":"indication"},{"label":"Sunovion Pharms Inc","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Hypnotics and Sedatives","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":1113.08,"date":"","count":1192,"signal":"Coma","source":"DrugCentral FAERS","actionTaken":"Reported 1,192 times (LLR=1113)"},{"llr":874.299,"date":"","count":1085,"signal":"Intentional overdose","source":"DrugCentral FAERS","actionTaken":"Reported 1,085 times (LLR=874)"},{"llr":868.279,"date":"","count":500,"signal":"Poisoning deliberate","source":"DrugCentral FAERS","actionTaken":"Reported 500 times (LLR=868)"},{"llr":794.265,"date":"","count":1246,"signal":"Lower respiratory tract infection","source":"DrugCentral FAERS","actionTaken":"Reported 1,246 times (LLR=794)"},{"llr":699.048,"date":"","count":573,"signal":"Intentional self-injury","source":"DrugCentral FAERS","actionTaken":"Reported 573 times (LLR=699)"},{"llr":526.34,"date":"","count":656,"signal":"Muscle injury","source":"DrugCentral FAERS","actionTaken":"Reported 656 times (LLR=526)"},{"llr":515.304,"date":"","count":689,"signal":"Folliculitis","source":"DrugCentral FAERS","actionTaken":"Reported 689 times (LLR=515)"},{"llr":472.812,"date":"","count":400,"signal":"Muscle spasticity","source":"DrugCentral FAERS","actionTaken":"Reported 400 times (LLR=473)"},{"llr":471.394,"date":"","count":478,"signal":"Ear pain","source":"DrugCentral FAERS","actionTaken":"Reported 478 times (LLR=471)"},{"llr":446.454,"date":"","count":1343,"signal":"Depression","source":"DrugCentral FAERS","actionTaken":"Reported 1,343 times (LLR=446)"},{"llr":432.611,"date":"","count":733,"signal":"Ill-defined disorder","source":"DrugCentral FAERS","actionTaken":"Reported 733 times (LLR=433)"},{"llr":431.095,"date":"","count":677,"signal":"Irritable bowel syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 677 times (LLR=431)"},{"llr":400.59,"date":"","count":1314,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 1,314 times (LLR=401)"},{"llr":357.847,"date":"","count":1192,"signal":"Sinusitis","source":"DrugCentral FAERS","actionTaken":"Reported 1,192 times (LLR=358)"},{"llr":354.258,"date":"","count":1494,"signal":"Confusional state","source":"DrugCentral FAERS","actionTaken":"Reported 1,494 times (LLR=354)"}],"commonSideEffects":[],"contraindications":["Alcohol intoxication","Asthenia","Depressive disorder","Hepatic failure","Severe chronic obstructive pulmonary disease","Sleep automatism","Suicidal thoughts"]},"trials":[],"aliases":[],"company":"Sunovion Pharms Inc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ZOPICLONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:27:48.806677+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:27:54.316198+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZOPICLONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:27:54.618753+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: GABA-A receptor; agonist GABA site positive allosteric modulator","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:27:55.670851+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL135400/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:27:55.327664+00:00"}},"allNames":"imovane","offLabel":[],"synonyms":["zopiclone","zimovane","imovane"],"timeline":[{"date":"2004-12-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sunovion Pharms Inc)"}],"aiSummary":"Imovane (Zopiclone) is a small molecule drug developed by Sunovion Pharmas Inc, targeting the GABA A receptor alpha-5/beta-2/gamma-2. It is a non-benzodiazepine hypnotic agent, classified as a zopiclone, approved by the FDA in 2004 for the treatment of insomnia. Imovane is still owned by Sunovion Pharmas Inc and is used to help individuals fall asleep and stay asleep. Key safety considerations include its potential for dependence and withdrawal symptoms. Imovane has a half-life of 5.2 hours.","approvals":[{"date":"2004-12-15","orphan":false,"company":"SUNOVION PHARMS INC","regulator":"FDA"}],"brandName":"Imovane","ecosystem":[{"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":{"target":"GABA A receptor alpha-5/beta-2/gamma-2","novelty":"Follow-on","targets":[{"gene":"GABRA5","source":"DrugCentral","target":"GABA A receptor alpha-5/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit alpha-5"},{"gene":"GABRB2","source":"DrugCentral","target":"GABA A receptor alpha-5/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit beta-2"},{"gene":"GABRG2","source":"DrugCentral","target":"GABA A receptor alpha-5/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit gamma-2"},{"gene":"GABRB3","source":"DrugCentral","target":"GABA-A receptor alpha-5/beta-3/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit beta-3"},{"gene":"GABRA1","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit alpha-1"},{"gene":"GABRG3","source":"DrugCentral","target":"GABA-A receptor alpha-1/beta-2/gamma-3","protein":"Gamma-aminobutyric acid receptor subunit gamma-3"},{"gene":"GABRA3","source":"DrugCentral","target":"GABA A receptor alpha-3/beta-2/gamma-2","protein":"Gamma-aminobutyric acid receptor subunit alpha-3"}],"modality":"Small Molecule","drugClass":"zopiclone","explanation":"","oneSentence":"","technicalDetail":"Imovane acts as a positive allosteric modulator of the GABA A receptor, specifically targeting the alpha-5/beta-2/gamma-2 subunit combination, which is involved in the regulation of sleep and wakefulness."},"commercial":{"launchDate":"2004","_launchSource":"DrugCentral (FDA 2004-12-15, SUNOVION PHARMS INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2873","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ZOPICLONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZOPICLONE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T16:12:16.604057","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:27:56.885309+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"zolpidem","drugSlug":"zolpidem","fdaApproval":"1992-12-16","patentExpiry":"Feb 25, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"zaleplon","drugSlug":"zaleplon","fdaApproval":"1999-08-13","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"eszopiclone","drugSlug":"eszopiclone","fdaApproval":"2004-12-15","genericCount":14,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"zopiclone","indications":{"approved":[{"name":"Insomnia","source":"DrugCentral","snomedId":193462001,"regulator":"FDA","usPrevalence":70000000,"globalPrevalence":750000000,"prevalenceMethod":"curated","prevalenceSource":"Sleep Medicine Reviews, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"zolpidem","brandName":"zolpidem","genericName":"zolpidem","approvalYear":"1992","relationship":"same-class"},{"drugId":"zaleplon","brandName":"zaleplon","genericName":"zaleplon","approvalYear":"1999","relationship":"same-class"},{"drugId":"eszopiclone","brandName":"eszopiclone","genericName":"eszopiclone","approvalYear":"2004","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03668041","phase":"PHASE3","title":"National Adaptive Trial for PTSD Related Insomnia","status":"ACTIVE_NOT_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2021-02-25","conditions":["Insomnia"],"enrollment":673,"completionDate":"2026-03-31"},{"nctId":"NCT07357272","phase":"","title":"A Cohort Study on Increasing Blood Pressure Benefits in Sleep Apnea Patients After CPAP Treatment","status":"RECRUITING","sponsor":"Beijing Anzhen 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