{"id":"melatonin-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Drowsiness"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL2108760","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Melatonin is an endogenous hormone that acts as a chronobiotic agent, synchronizing the body's internal clock with external light-dark cycles. By activating melatonin receptors in the suprachiasmatic nucleus and other tissues, it facilitates sleep onset and maintains circadian homeostasis. The injectable formulation allows for direct systemic delivery, potentially providing more consistent pharmacokinetics than oral administration.","oneSentence":"Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep-wake cycle normalization.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:54:15.828Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Circadian rhythm sleep disorders"},{"name":"Insomnia (sleep initiation and maintenance)"}]},"trialDetails":[{"nctId":"NCT07316582","phase":"PHASE4","title":"Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management Periodontitis","status":"ENROLLING_BY_INVITATION","sponsor":"Al-Azhar University","startDate":"2025-11-01","conditions":"Periodontitis Stage II","enrollment":60},{"nctId":"NCT07162272","phase":"PHASE4","title":"The Efficacy of Melatonin Patches on Dental Anxiety in Children","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2025-06-25","conditions":"Dental Anxiety, Children","enrollment":52},{"nctId":"NCT05541276","phase":"PHASE3","title":"MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children","status":"RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2025-01-21","conditions":"Emergence Delirium","enrollment":400},{"nctId":"NCT06405204","phase":"PHASE3","title":"of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve","status":"NOT_YET_RECRUITING","sponsor":"Beni-Suef University","startDate":"2024-06-30","conditions":"IVF","enrollment":200},{"nctId":"NCT05759416","phase":"PHASE4","title":"Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis","status":"COMPLETED","sponsor":"Al-Azhar University","startDate":"2020-04-01","conditions":"Chronic Periodontitis","enrollment":40},{"nctId":"NCT00649961","phase":"PHASE2","title":"Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study","status":"COMPLETED","sponsor":"Imperial College London","startDate":"2010-05","conditions":"Premature Birth, Brain Injury","enrollment":18},{"nctId":"NCT01172171","phase":"PHASE2","title":"The Effect of Melatonin on Ischemia-reperfusion Injury Following Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Herlev Hospital","startDate":"2013-06","conditions":"Acute Myocardial Infarction, Ischemia-reperfusion Injury","enrollment":41},{"nctId":"NCT01200641","phase":"PHASE1, PHASE2","title":"Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin","status":"COMPLETED","sponsor":"Qazvin University Of Medical Sciences","startDate":"2010-09","conditions":"Anxiety, Pain","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":182,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CAS-73314"],"phase":"marketed","status":"active","brandName":"Melatonin injection","genericName":"Melatonin injection","companyName":"Imperial College London","companyId":"imperial-college-london","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep-wake cycle normalization. Used for Circadian rhythm sleep disorders, Insomnia, Sleep disturbances in hospitalized or critically ill patients.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}