Melatonin clinical trials
Melatonin is named as an intervention in 25 current clinical trials in our Egypt, Denmark, Australia, China, Netherlands, Sweden, Switzerland, Canada and Mexico registers. 17 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Tanta University (5). The most-studied condition is Insomnia.
Where Melatonin is approved
All regulators →Of the three regulators tracked here, the first to approve Melatonin was the EU, on 29 Jun 2007. It is approved in 2 of the 3 regulators tracked here.
- 19 EU orphan designations, most recently for treatment of perinatal asphyxia (15 Feb 2023, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Melatonin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Melatonin works
All drug targets →- Melatonin receptor agonist AgonistTarget: Melatonin receptor✓ In ChEMBL and the Guide to Pharmacology
- Back painPhase 3
- CachexiaPhase 3
- Low back painPhase 3
- Multiple Organ FailurePhase 3
- SepsisPhase 3
- Sleep disturbancePhase 3
- Abnormal glucose tolerancePhase 3
- Anorexia nervosaPhase 3
- AnxietyPhase 3
- Attention deficit-hyperactivity disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL45, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 1357, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Melatonin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 9 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Circadin, Melatonin Neurim, SlenytoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Melatonin
- ATC code
- N05CH01
- ChEMBL
- CHEMBL45
- DrugBank
- DB01065
- PubChem CID
- 896
- CAS number
- 8041-44-9
- FDA UNII
- JL5DK93RCL
- Wikidata
- Q180912
- Wikipedia
- Melatonin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Melatonin
25 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Melatonin across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
9 single-substance products containing Melatonin on the HPRA medicines list.
- Meladura 2 mg prolonged-release tabletsBluefish Pharmaceuticals AB · PA1436/047/001 · Marketed
- Melnite 2 mg prolonged-release tabletsPinewood Laboratories Ltd · PA0281/265/001 · Marketed
- Calasu 2 mg prolonged-release tabletsAthlone Pharmaceuticals Limited · PA1418/018/001
- Circadin 2 mg prolonged-release tabletsRAD Neurim Pharmaceuticals EEC SARL · EU/1/07/392/001
- Melatonin Neurim 2 mg prolonged-release tabletsRAD Neurim Pharmaceuticals EEC SARL · EU/1/22/1694/001-004
Supply shortages
No entry for Melatonin in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Melatonin
46 conditionsAll 46 conditions
| Condition (as registered) | Trials |
|---|---|
| Insomnia | 2 |
| Oral Melatonin | 2 |
| Fetal Growth Restriction (FGR) | 1 |
| Chronic Low-back Pain (cLBP) | 1 |
| Uveal Melanoma | 1 |
| Uveal Melanoma, Posterior, Medium/Large Size | 1 |
| Eye Cancer, Intraocular Melanoma | 1 |
| Bipolar Affective Disorder | 1 |
| Emergence Delirium | 1 |
| Psychiatric Disorders | 1 |
| Hypoactive Delirium | 1 |
| Delirium | 1 |
| Obstructive Sleep Apnea of Adult | 1 |
| Fetal Growth Retardation | 1 |
| Stillbirth and Fetal Death | 1 |
| Pregnancy Preterm | 1 |
| Therapy | 1 |
| Treatment | 1 |
| ICS | 1 |
| Ureteral Stent-Related Symptoms | 1 |
| Ureteral Calculi | 1 |
| Lower Urinary Tract Symptoms | 1 |
| Breast Cancer | 1 |
| Sleep Disturbance | 1 |
| Comparative Effectiveness | 1 |
| Congenital Peumonia | 1 |
| Persistent Pulmonary Hypertension of Newborn | 1 |
| Congenital Diaphragmatic Hernia | 1 |
| Oral | 1 |
| Melatonin | 1 |
| Pregabalin | 1 |
| Postoperative Pain | 1 |
| Diabetic Peripheral Neuropathy | 1 |
| Diabetic Neuropathy | 1 |
| Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients | 1 |
| Post Tonsillectomy Emergence Agitation | 1 |
| Nebulized Dexmedetomidine | 1 |
| Emergence Agitation | 1 |
| Children | 1 |
| Lidocaine Infusion | 1 |
| Postoperative Delirium | 1 |
| Elderly Patients | 1 |
| Cardiomyopathies | 1 |
| Tracheal Intubation Morbidity | 1 |
| Laryngoscopy | 1 |
| Hemodynamic Response | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Tanta University | 5 |
| Ain Shams University | 4 |
| Benha University | 3 |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | 1 |
| Bart Koes | 1 |
| Gustav Stalhammar | 1 |
| Lars Vedel Kessing | 1 |
| Arash Afshari | 1 |
| Lone Baandrup | 1 |
| University Hospital, Basel, Switzerland | 1 |
| Ciusss de L'Est de l'Île de Montréal | 1 |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | 1 |
| Woolcock Institute of Medical Research | 1 |
| Monash University | 1 |
| Beni-Suef University | 1 |
+ 1 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Melatonin trials
How many clinical trials are testing Melatonin?
25 current trials in our Egypt, Denmark, Australia, China, Netherlands, Sweden, Switzerland, Canada and Mexico registers name Melatonin as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Melatonin trials recruiting patients?
Yes. 17 of the 25 trials are recruiting: 8 with sites in Egypt, 3 with sites in Denmark, 2 with sites in Australia, 1 with sites in Sweden, 1 with sites in Switzerland, 1 with sites in Canada and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Melatonin clinical trials?
Tanta University (5), Ain Shams University (4), Benha University (3) and Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (1), among 16 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Melatonin licensed in Ireland?
Yes. The HPRA medicines list includes 9 single-substance products containing Melatonin, for example Meladura 2 mg prolonged-release tablets (Bluefish Pharmaceuticals AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Melatonin shortage?
Not in the lists we track: Melatonin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Melatonin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Melatonin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Melatonin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.