Overview
Melatonin is a biogenic amine that is found in animals, plants and microbes. Aaron B. Lerner of Yale University is credited for naming the hormone and for defining its chemical structure in 1958. In mammals, melatonin is produced by the pineal gland. The pineal gland is small endocrine gland, about the size of a rice grain and shaped like a pine cone (hence the name), that is located in the center of the brain (rostro-dorsal to the superior colliculus) but outside the blood-brain barrier. The secretion of melatonin increases in darkness and decreases during exposure to light, thereby regulating the circadian rhythms of several biological functions, including the sleep-wake cycle. In particular, melatonin regulates the sleep-wake cycle by chemically causing drowsiness and lowering the body temperature. Melatonin is also implicated in the regulation of mood, learning and memory, immune activity, dreaming, fertility and reproduction. Melatonin is also an effective antioxidant. Most of the actions of melatonin are mediated through the binding and activation of melatonin receptors. Individuals with autism spectrum disorders (ASD) may have lower than normal levels of melatonin. A 2008 study found that unaffected parents of individuals with ASD also have lower melatonin levels, and that the deficits were associated with low activity of the ASMT gene, which encodes the last enzyme of melatonin synthesis. Reduced melatonin production has also been proposed as a likely factor in the significantly higher cancer rates in night workers.
Indication
Used orally for jet lag, insomnia, shift-work disorder, circadian rhythm disorders in the blind (evidence for efficacy), and benzodiazepine and nicotine withdrawal. Evidence indicates that melatonin is likely effective for treating circadian rhythm sleep disorders in blind children and adults. It has received FDA orphan drug status as an oral medication for this use. A number of studies have shown that melatonin may be effective for treating sleep-wake cycle disturbances in children and adolescents with mental retardation, autism, and other central nervous system disorders. It appears to decrease the time to fall asleep in children with developmental disabilities, such as cerebral palsy, autism, and mental retardation. It may also improve secondary insomnia associated with various sleep-wake cycle disturbances. Other possible uses for which there is some evidence for include: benzodiazepine withdrawal, cluster headache, delayed sleep phase syndrome (DSPS), primary insomnia, jet lag, nicotine withdrawal, preoperative anxiety and sedation, prostate cancer, solid tumors (when combined with IL-2 therapy in certain cancers), sunburn prevention (topical use), tardive dyskinesia, thrombocytopenia associated with cancer, chemotherapy and other disorders.
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/25 | Phase 2 | Not yet recruiting | |||
2025/06/24 | Phase 4 | Active, not recruiting | |||
2025/05/30 | Not Applicable | Recruiting | CMH Kharian Medical College | ||
2025/04/29 | Phase 1 | Recruiting | Mian Muhammad Hassan Ahmed | ||
2025/04/20 | Phase 2 | Not yet recruiting | |||
2025/03/27 | Phase 4 | Completed | Konya City Hospital | ||
2025/03/25 | Early Phase 1 | Recruiting | |||
2025/03/25 | Phase 3 | Recruiting | |||
2025/03/05 | Phase 3 | Not yet recruiting | Bart Koes | ||
2025/02/20 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
BioActive Nutritional, Inc. | 43857-0020 | ORAL | 6 [hp_X] in 1 mL | 5/14/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 11/7/2022 | ||
Authorised | 9/20/2018 | ||
Authorised | 6/29/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
CIRCADIN™ PROLONGED RELEASE TABLETS 2MG | SIN13954P | TABLET, EXTENDED RELEASE | 2 mg | 5/4/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
SLENYTO melatonin 1 mg prolonged release tablet blister pack | 319503 | Medicine | A | 5/22/2020 | |
MELAKSO melatonin 5 mg capsule blister pack | 388307 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 10/27/2023 |
APOHEALTH MELATONIN SLEEP AID melatonin 2 mg modified release tablet blister pack | 250293 | Medicine | A | 4/4/2017 | |
MELATONIN SANDOZ SLEEP AID melatonin 2 mg modified release tablet blister pack | 395857 | Medicine | A | 9/12/2022 | |
Xativa Sleep 20mg/5mg | 430030 | Medicine | A | 12/6/2023 | |
PHARMACY HEALTH MELATONIN 2 mg modified release tablet blister pack | 440553 | Medicine | A | 2/9/2024 | |
A-one MELATONIN SLEEP melatonin 2 mg prolonged release tablet blister pack | 479685 | Medicine | A | 2/18/2025 | |
MELATONIN MR-TEVA melatonin 2 mg modified release tablet blister pack | 384006 | Medicine | A | 2/15/2022 | |
MELATONIN VIATRIS melatonin 2 mg modified release tablets blister pack | 421718 | Medicine | A | 9/13/2023 | |
CHEMMART MELATONIN MR melatonin 2 mg modified release tablet blister pack | 250297 | Medicine | A | 4/4/2017 |
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