5
26
↑5
↓0
—26
Evidence suggests Melatonin haslittle to no effecton Safety.
34 studies (31 claims)
Strong consensus
Typical effective dose 6 (3.5–10) mgacross 11 dosed studies
Study Claims
| Intervention | Direction | Endpoint | Type | Population | Dosage | Title |
|---|---|---|---|---|---|---|
| short-term use of melatonin | No effect - is safe | safety | Human | animal and human studies | Not specified | The Safety of Melatonin in Humans.cited 302× |
| exogenous melatonin | No effect - should not take | safety | Human | pregnant and breast-feeding women | Not specified | The Safety of Melatonin in Humans.cited 302× |
| oral melatonin supplementation | No effect - has a generally favourable safety profile | safety profile | Human | humans | Not specified in the abstract. | Adverse events associated with oral administration of melatonin: A critical systematic review of clinical evidence.cited 89× |
| melatonin | No effect - No adverse safety events were identified to be significantly associated | adverse safety events | Human | children | — | Melatonin for pre-medication in children: a systematic review.cited 11× |
| Melatonin | No effect - appears to have | a favorable safety profile | Human | older adults (defined by age over 65 years) | — | Current Insights into the Risks of Using Melatonin as a Treatment for Sleep Disorders in Older Adults.cited 21× |
| melatonin | No effect - appears to have | a good safety profile | Human | human adults over 30 years of age | ≥10 mg (high-dose melatonin) | Safety of higher doses of melatonin in adults: A systematic review and meta-analysis.cited 67× |
| melatonin | No effect - few studies document | efficacy and safety | Human | these populations | Not specified | Melatonin Treatment in Children with Developmental Disabilities.cited 28× |
| melatonin | No effect - show how it could be evaluated, but with no conclusive evidence of efficacy and safety | efficacy and safety | HumanMolecular | clinical trials | Not specified | Assessing the antiviral potential of melatonin: A comprehensive systematic review.cited 6× |
| melatonin | No effect - commonly associated with | naturalness and safety | Human | caregivers of children and adolescents | Not specified | Melatonin use in children and adolescents: A scoping review of caregiver perspectives.cited 7× |
| melatonin | Increases - presents a superior safety profile | safety | Human | adults and in children | Not specified in the abstract. | Endogenous Melatonin Levels and Therapeutic Use of Exogenous Melatonin in Migraine: Systematic Review and Meta-Analysis.cited 41× |
| melatonin | No effect - equally safe | safety | Human | adults | Not specified in the abstract. | Endogenous Melatonin Levels and Therapeutic Use of Exogenous Melatonin in Migraine: Systematic Review and Meta-Analysis.cited 41× |
| Melatonin | No effect - was essentially safe | safety | Human | — | — | Assessing the potential for drug interactions and long term safety of melatonin for the treatment of insomnia in children with autism spectrum disorder.cited 6× |
| melatonin | No effect - can be exogenously taken safely | safety | Human | — | Not specified | Melatonin and male reproductive health: relevance of darkness and antioxidant properties.cited 32× |
| melatonin | No effect - appears safe | safety | Human | — | Not specified. | ALSUntangled #61: melatonin.cited 2× |
| melatonin | No effect - safe for both mother and fetus | safety | Human | mother and fetus | Not specified | Potential Utility of Melatonin in Preeclampsia, Intrauterine Fetal Growth Retardation, and Perinatal Asphyxia.cited 48× |
| melatonin | No effect - seems to be safe and well tolerated | safety and tolerability | Human | — | 6 mg slow-release melatonin at bedtime. | A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood.cited 48× |
| melatonin | No effect - appears to be safe and well-tolerated | safety and tolerability | Human | — | Not specified | Melatonin: Implications for Ocular Disease and Therapeutic Potential.cited 12× |
| melatonin | No effect - was safe | safety for mothers and their fetuses | Human | 20 women with preeclampsia | Not specified in the abstract. | Melatonin improves endothelial function in vitro and prolongs pregnancy in women with early-onset preeclampsia.cited 102× |
| melatonin | No effect - was associated with similar safety profiles | safety profiles | Human | IBS patients | — | The efficacy of exogenous melatonin supplement in ameliorating irritable bowel syndrome severity: A meta-analysis of randomized controlled trials.cited 6× |
| exogenous melatonin | No effect - only few and minor side effects | safety | Human | individuals with ASD | Not specified | Melatonin for disordered sleep in individuals with autism spectrum disorders: systematic review and discussion.cited 53× |
| exogenous melatonin | No effect - have not suggested major safety concerns or adverse events | safety | Human | during pregnancy and breastfeeding | Not specified | Melatonin use during pregnancy and lactation: A scoping review of human studies.cited 16× |
| exogenous melatonin | No effect - is probably safe | safety | Human | during pregnancy and breastfeeding in humans | Not specified | Melatonin use during pregnancy and lactation: A scoping review of human studies.cited 16× |
| Extended-release melatonin (4 mg) | No effect - safety parameters remained within normal ranges | safety parameters | Human | 18 healthy adults, ages 18-65 years | 4 mg (single dose for each formulation). | A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults.cited 4× |
| Immediate-release melatonin (4 mg) | No effect - safety parameters remained within normal ranges | safety parameters | Human | 18 healthy adults, ages 18-65 years | 4 mg (single dose for each formulation). | A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults.cited 4× |
| Melatonin in a prolonged-release form | Increases - high safety of the therapy | treatment safety | Human | people over 65 years of age | Not specified | Treatment of insomnia in older adults. Recommendations of the Polish Sleep Research Society, Polish Society of Family Medicine and the Polish Psychiatric Association.cited 1× |
| a single preoperative enteral dose of melatonin | No effect - is safe | safety | Human | patients undergoing major liver surgery | 50 mg/kg BW, single dose. | The use of high-dose melatonin in liver resection is safe: first clinical experience.cited 86× |
| melatonin treatment | No effect - There was no serious adverse event | safety | Human | patients after melatonin treatment | 50 mg/kg BW, single dose. | The use of high-dose melatonin in liver resection is safe: first clinical experience.cited 86× |
| oral melatonin | No effect - might elucidate the safety | safety | Human | patients with HF | 10 mg tablets of melatonin daily. | Effect of melatonin on heart failure: design for a double-blinded randomized clinical trial.cited 18× |
| Supplemental melatonin | Increases - was safe | safety | Human | children | 1 or 3 mg | Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes.cited 146× |
| Prolonged release melatonin (PRM) | No effect - no clinically relevant differences | any safety outcome | Human | patients | Not specified in the abstract. | Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety.cited 96× |
| prolonged-release melatonin (PRM) | No effect - did not complain of side effects | safety | Human | all enrolled subjects | 2 mg of PRM. | Prolonged-release melatonin in Parkinson's disease patients with a poor sleep quality: A randomized trial.cited 39× |
| Prolonged-release melatonin (PRM) | Increases - tolerability and safety are excellent | tolerability and safety | Human | — | Not specified | The use of prolonged-release melatonin in circadian medicine: a systematic review.cited 1× |
| continuous release and absorption melatonin (CRA-melatonin) | No effect - there were no treatment-emergent adverse events reported | safety profile | Human | healthy adult volunteers | 5 mg single dose | A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation.cited 5× |
| immediate-release melatonin (IR-melatonin) | Increases - treatment-emergent adverse events occurred | safety profile | Human | healthy adult volunteers | 5 mg single dose | A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation.cited 5× |
| melatonin to augment HT | No effect - has been studied | safety and efficacy | Human | neonatal piglet model of perinatal asphyxia | 15-30 mg/L (therapeutic levels). | Melatonin for Neonatal Encephalopathy: From Bench to Bedside.cited 12× |
| prolonged-release melatonin treatment | No effect - were assessed | long-term effectiveness and safety | Human | 88 children (42 girls and 46 boys) with neurodevelopmental disorders | 4-6 mg | Prolonged-release melatonin for children with neurodevelopmental disorders.cited 49× |
| maternal melatonin administration | No effect - treatment is safe | safety | Human | pregnancies complicated by placental insufficiency | — | The role of melatonin in pregnancies complicated by placental insufficiency: A systematic review.cited 7× |
| Preoperative oral melatonin | No effect - has a favorable safety profile | safety | Human | children | Intravenous melatonin 0.15 mg/kg administered once approximately 30 minutes before the end of surgery. | Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA-PAED): A protocol and statistical analysis plan for a randomized clinical trial.cited 1× |
| intraoperative intravenous melatonin | No effect - investigates the safety | safety | Human | pediatric surgical patients | Intravenous melatonin 0.15 mg/kg administered once approximately 30 minutes before the end of surgery. | Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA-PAED): A protocol and statistical analysis plan for a randomized clinical trial.cited 1× |
| melatonin as an add-on treatment | No effect - to assess the efficacy and safety | efficacy and safety | Human | Participants aged 3 months to 2 years with a primary diagnosis of infantile epileptic spasms syndrome (IESS) | Not available | Safety and efficacy of melatonin supplementation as an add-on treatment for infantile epileptic spasms syndrome: A randomized, placebo-controlled, double-blind trial.cited 5× |
| combination of adrenocorticotropic hormone, magnesium sulfate and either melatonin or placebo | No effect - assessed | safety | Human | Patients aged 3 months to 2 years with IS | — | Melatonin supplementation for the treatment of infantile spasms: protocol for a randomised placebo-controlled triple-blind trial.cited 3× |