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A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study

NCT06802913 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-18

No results posted yet for this study

Summary

The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer is: does inhaled melatonin affect the sleep profiles of adults with insomnia differently than oral melatonin tablets?

10 Participants will:

* Visit the research institute for a screening visit, for an overnight visit at the beginning of each study drug treatment and for a blood collection visit at the end of the conclusion of each study drug treatment period (5 visits in total)
* Take 100 µg of inhaled melatonin (2 inhaler puffs) nightly for two weeks
* Take a 4 mg of oral melatonin (2 tablets) nightly for two weeks

Conditions

Interventions

DRUG

Inhaled Melatonin (100 μg)

An orally inhaled formulation of melatonin delivered by pressurised metered dose inhaler (pMDI) to be taken before bedtime. The pMDI will deliver a total of 100 μg of inhaled melatonin (2 x 50 μg/actuation). The investigational product is produced under Good Manufacturing Practice by Ab Initio Pharma Pty Ltd, a GMP certified manufacturer of pharmaceutical products.

DRUG

Oral Melatonin (4 mg)

Two orally ingested tablets each containing 2 mg of melatonin (4 mg total) to be taken before bedtime. The investigational product is manufactured under Good Manufacturing Practice and is compliant with the TGA Therapeutic Order #101 that stipulates quality control requirements for capsule and pill-based products used in Australia.

Sponsors & Collaborators

  • Woolcock Institute of Medical Research

    lead OTHER

Principal Investigators

  • Hui Xin Ong, PhD · Woolcock Institute of Medical Research

  • Ron Grunstein, MBBS MD PhD FRACP · Woolcock Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802913 on ClinicalTrials.gov