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Compound · clinical trials

Melatonin clinical trials

Also listed in trial records as Circadin
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 23 trials in our Egypt, Denmark, Australia, Netherlands, Sweden, Switzerland, Canada and Mexico registers that name Melatonin as an intervention. Synced 26 Sep 2026
23Current trials
17Recruiting now
16Lead sponsors
8Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Melatonin is named as an intervention in 23 current clinical trials in our Egypt, Denmark, Australia, 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.

Trials by status

  • Recruiting1774%
  • Not yet open417%
  • Active, closed29%

Trials by phase

  • Phase 3522%
  • Phase 2522%
  • Not applicable522%
  • Phase 2/3313%
  • Phase 429%
  • Phase EARLY_PHASE129%
  • Phase 1/214%
01

Clinical trials of Melatonin

23 trials
StudyPhaseStatusLead sponsorRegisters
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
NCT06802913 · ClinicalTrials.gov ↗ · Insomnia
Phase EARLY_PHASE1 Recruiting Woolcock Institute of Medical Research Australia
The Basel BOMP-AID Randomized Trial
NCT03438526 · ClinicalTrials.gov ↗ · Hypoactive Delirium
Phase 4 Recruiting University Hospital, Basel, Switzerland Switzerland
Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)
NCT06380491 · ClinicalTrials.gov ↗ · Obstructive Sleep Apnea of Adult
Phase 4 Recruiting Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico
Adjuvant Melatonin for Uveal Melanoma
NCT05502900 · ClinicalTrials.gov ↗ · Uveal Melanoma, Uveal Melanoma, Posterior, Medium/Large Size, Eye Cancer, Intraocular Melanoma
Phase 3 Recruiting Gustav Stalhammar Sweden
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
NCT05541276 · ClinicalTrials.gov ↗ · Emergence Delirium
Phase 3 Recruiting Arash Afshari Denmark
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
NCT05651347 · ClinicalTrials.gov ↗ · Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm
Phase 3 Recruiting Monash University Australia
Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy
NCT06846086 · ClinicalTrials.gov ↗ · Cardiomyopathies
Phase 3 Recruiting Tanta University Egypt
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
NCT06062953 · ClinicalTrials.gov ↗ · Psychiatric Disorders, Insomnia
Phase 2/3 Recruiting Lone Baandrup Denmark
Melatonin for Treatment of Delirium in Critically Ill Adult Patients
NCT05713877 · ClinicalTrials.gov ↗ · Delirium
Phase 2 Recruiting Ciusss de L'Est de l'รŽle de Montrรฉal Canada
Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
NCT07036796 · ClinicalTrials.gov ↗ · Diabetic Peripheral Neuropathy, Diabetic Neuropathy, Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients
Phase 2 Recruiting Ain Shams University Egypt
Melatonin Versus Placebo for Bipolar Disorder
NCT07472075 · ClinicalTrials.gov ↗ · Bipolar Affective Disorder
Phase 2 Recruiting Lars Vedel Kessing Denmark
Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
NCT07617922 · ClinicalTrials.gov ↗ · Ureteral Stent-Related Symptoms, Ureteral Calculi, Lower Urinary Tract Symptoms
Phase 2 Recruiting Beni-Suef University Egypt
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
NCT06768580 · ClinicalTrials.gov ↗ · Oral Melatonin, Lidocaine Infusion, Postoperative Delirium
Not applicable Recruiting Tanta University Egypt
Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery
NCT07344467 · ClinicalTrials.gov ↗ · Oral, Melatonin, Pregabalin
Not applicable Recruiting Tanta University Egypt
Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
NCT07345715 · ClinicalTrials.gov ↗ · Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation
Not applicable Recruiting Tanta University Egypt
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
NCT07375342 · ClinicalTrials.gov ↗ · Post Tonsillectomy Emergence Agitation
Not applicable Recruiting Benha University Egypt
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
NCT07610876 · ClinicalTrials.gov ↗ · Dental Implants, Immediate Implant Placement, Osseointegration
Not applicable Recruiting Suez Canal University Egypt
Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty
NCT07732725 · ClinicalTrials.gov ↗ · Sleep Disturbance
Phase EARLY_PHASE1 Not yet open Benha University Egypt
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
NCT06935292 · ClinicalTrials.gov ↗ · Tracheal Intubation Morbidity, Laryngoscopy, Hemodynamic Response
Phase 2/3 Not yet open Tanta University Egypt
Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients
NCT07721324 · ClinicalTrials.gov ↗ · Therapy, Treatment
Phase 2/3 Not yet open Ain Shams University Egypt
Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT07067307 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 1/2 Not yet open Mansoura University Egypt
Melatonin for Patients With Chronic Low Back Pain
NCT06859957 · ClinicalTrials.gov ↗ · Chronic Low-back Pain (cLBP)
Phase 3 Active, closed Bart Koes Netherlands
Melatonin Therapy for Improving ICSI Outcomes in Women With Diminished Ovarian Reserve
NCT07318974 · ClinicalTrials.gov ↗ · ICS
Phase 2 Active, closed Benha University Egypt

Registers 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.

02

Melatonin across our data

Ireland · EU · US

The 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.

All 9 Irish products →

Supply shortages

No entry for Melatonin in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Melatonin

44 conditions
Insomnia2Oral Melatonin2Chronic Low-back Pain (cLBP)1Uveal Melanoma1Uveal Melanoma, Posterior, Medium/Large Size1Eye Cancer, Intraocular Melanoma1Psychiatric Disorders1Bipolar Affective Disorder1Emergence Delirium1Hypoactive Delirium1Delirium1Obstructive Sleep Apnea of Adult1
All 44 conditions
Condition (as registered)Trials
Insomnia2
Oral Melatonin2
Chronic Low-back Pain (cLBP)1
Uveal Melanoma1
Uveal Melanoma, Posterior, Medium/Large Size1
Eye Cancer, Intraocular Melanoma1
Psychiatric Disorders1
Bipolar Affective Disorder1
Emergence Delirium1
Hypoactive Delirium1
Delirium1
Obstructive Sleep Apnea of Adult1
Fetal Growth Retardation1
Stillbirth and Fetal Death1
Pregnancy Preterm1
Post Tonsillectomy Emergence Agitation1
Breast Cancer1
Oral1
Melatonin1
Pregabalin1
Postoperative Pain1
Nebulized Dexmedetomidine1
Emergence Agitation1
Children1
Sleep Disturbance1
Cardiomyopathies1
Diabetic Peripheral Neuropathy1
Diabetic Neuropathy1
Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients1
ICS1
Ureteral Stent-Related Symptoms1
Ureteral Calculi1
Lower Urinary Tract Symptoms1
Therapy1
Treatment1
Dental Implants1
Immediate Implant Placement1
Osseointegration1
Lidocaine Infusion1
Postoperative Delirium1
Elderly Patients1
Tracheal Intubation Morbidity1
Laryngoscopy1
Hemodynamic Response1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Tanta University5
Benha University3
Ain Shams University2
Bart Koes1
Gustav Stalhammar1
Lone Baandrup1
Lars Vedel Kessing1
Arash Afshari1
University Hospital, Basel, Switzerland1
Ciusss de L'Est de l'รŽle de Montrรฉal1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1
Monash University1
Woolcock Institute of Medical Research1
Mansoura University1
Beni-Suef University1

+ 1 more sponsors in the trial list above.

05

By country register

RegisterTrialsRecruiting
Clinical trials in Egypt138
Clinical trials in Denmark33
Clinical trials in Australia22
Clinical trials in Netherlands10
Clinical trials in Sweden11
Clinical trials in Switzerland11
Clinical trials in Canada11
Clinical trials in Mexico11

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Melatonin trials

How many clinical trials are testing Melatonin?

23 current trials in our Egypt, Denmark, Australia, Netherlands, Sweden, Switzerland, Canada and Mexico registers name Melatonin as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Melatonin trials recruiting patients?

Yes. 17 of the 23 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), Benha University (3), Ain Shams University (2) and Bart Koes (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.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” 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.

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 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.