Actively Recruiting
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study
Led by Woolcock Institute of Medical Research · Updated on 2025-07-18
5
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from body different to that of oral melatonin tablets, in adults with insomnia? 5 participants will: * Visit the research institute for a screening visit and for a daytime visit to take a melatonin treatment then provide blood samples over the course of 8 hours for each study drug treatment (3 visits in total) * Take 100 μg of inhaled melatonin (2 inhaler puffs) once * Take a 4 mg of oral melatonin (2 tablets) once
CONDITIONS
Official Title
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 years and older
- Diagnosis of insomnia disorder as defined by DSM-5 with difficulty initiating or maintaining sleep or early awakening at least 3 nights per week for at least 3 months
- Insomnia Severity Index (ISI) score of 15 or higher
- Subjective sleep onset latency of 30 minutes or more on at least 3 nights per week in the past 4 weeks
- Able to provide informed electronic consent
- Fluent in English
You will not qualify if you...
- Highly dependent on medical care as determined by a medical officer
- Untreated moderate to severe sleep apnoea (oxygen desaturation index >15) unless effectively treated with ongoing insomnia
- Circadian rhythm disorders, narcolepsy, severe restless legs syndrome, REM sleep behaviour disorder, or uncontrolled psychiatric disorders
- History of attempted suicide or current suicide ideation (score >0 on Q9 of Patient Health Questionnaire-9)
- Objective cognitive decline (Montreal Cognitive Assessment score 6)
- Regular shift work, jet lag, or travel across more than 2-hour time zones within the past week
- Pregnancy or lactation; women of childbearing potential must have a negative pregnancy test and use contraception during the study
- Any condition that contraindicates participation according to investigator judgment
- Participation in another investigational study within 4 weeks prior to enrollment
- Ongoing use of specific medications including antipsychotics, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, or illicit stimulants
- Regular use of hypnotics, sedating medications, or psychostimulants within 14 days or 4-5 half-lives before starting the trial
- Use of antidepressants for less than one year or recent dose changes within the past year
- Regular opioid use within 14 days or 4-5 half-lives before starting the trial
- Use of THC- or CBD-containing products within 14 days prior to the trial
- Drug or alcohol dependence within the past two years (alcohol limited to no more than 2 standard drinks per day during the trial)
- Regular use of drugs that inhibit or induce CYP1A2 enzymes (e.g., amiodarone, cimetidine, ciprofloxacin, fluvoxamine, carbamazepine, phenobarbital, rifampin, tobacco)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
Research Team
H
Hui Xin Ong, PhD
CONTACT
D
Darren Zhao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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