{"id":"sublingual-melatonin","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Drowsiness"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL45","moleculeType":"Small molecule","molecularWeight":"232.28"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Melatonin is an endogenous hormone produced by the pineal gland that acts as a circadian regulator. When administered sublingually, it crosses the blood-brain barrier and activates melatonin receptors, particularly MT1 and MT2 subtypes, which modulate sleep-wake cycles and circadian-dependent physiological processes. This mechanism makes it effective for treating sleep disorders and circadian rhythm disturbances.","oneSentence":"Melatonin binds to melatonin receptors (MT1 and MT2) in the brain to regulate circadian rhythm and promote sleep.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:09:52.439Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Insomnia and sleep-onset disorders"},{"name":"Circadian rhythm sleep disorders"}]},"trialDetails":[{"nctId":"NCT07036367","phase":"PHASE4","title":"The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery","status":"RECRUITING","sponsor":"Al-Azhar University","startDate":"2025-09-01","conditions":"Cataract Surgery Anesthesia","enrollment":60},{"nctId":"NCT06997263","phase":"NA","title":"Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery","status":"COMPLETED","sponsor":"Benha University","startDate":"2024-01-15","conditions":"Anxiety, Postoperative Pain, Anesthesia","enrollment":96},{"nctId":"NCT04831398","phase":"PHASE4","title":"The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation","status":"RECRUITING","sponsor":"University of Oklahoma","startDate":"2023-01-01","conditions":"Healthy","enrollment":100},{"nctId":"NCT04247646","phase":"NA","title":"SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty","status":"ACTIVE_NOT_RECRUITING","sponsor":"Scripps Health","startDate":"2020-10-01","conditions":"Opioid Use, Pain, Postoperative, Sleep","enrollment":120},{"nctId":"NCT03951025","phase":"PHASE2","title":"Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN)","status":"COMPLETED","sponsor":"Technological Centre of Nutrition and Health, Spain","startDate":"2019-06-05","conditions":"Biological Availability","enrollment":13},{"nctId":"NCT05224167","phase":"NA","title":"Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture","status":"UNKNOWN","sponsor":"Mongi Slim Hospital","startDate":"2022-03-01","conditions":"Preoperative Anxiety","enrollment":50},{"nctId":"NCT03567395","phase":"NA","title":"Honey to Improve Sleep Quality: a Feasibility Study","status":"COMPLETED","sponsor":"University of Saskatchewan","startDate":"2018-04-18","conditions":"Poor Quality Sleep","enrollment":20},{"nctId":"NCT02200172","phase":"PHASE2","title":"The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study","status":"COMPLETED","sponsor":"Bruyère Health Research Institute.","startDate":"2014-12","conditions":"Cancer","enrollment":60},{"nctId":"NCT01572805","phase":"PHASE1, PHASE2","title":"Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section","status":"COMPLETED","sponsor":"Qazvin University Of Medical Sciences","startDate":"2012-02","conditions":"Post Partum Haemorrhage in Patients Undergoing Cesarean Section","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Sublingual Melatonin","genericName":"Sublingual Melatonin","companyName":"Al-Azhar University","companyId":"al-azhar-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Melatonin binds to melatonin receptors (MT1 and MT2) in the brain to regulate circadian rhythm and promote sleep. Used for Insomnia and sleep-onset disorders, Circadian rhythm sleep disorders.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}