Actively Recruiting
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
Led by Woolcock Institute of Medical Research · Updated on 2025-07-18
10
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: 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
Official Title
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI.
- History of subjective sleep onset latency (sSOL) ≥30 minutes on at least 3 nights per week in the previous 4 weeks.
- Able to provide informed electronic consent.
- Fluent English literacy.
- Adults aged 55+ years old.
You will not qualify if you...
- People highly dependent on medical care as determined by a medical officer.
- Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index>15, ongoing effectively treated sleep apnoea with insomnia will be allowed).
- Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders.
- History of attempted suicide or current suicide ideation (indicated by a score >0 on Q9 of the Patient Health Questionnaire-9) at pre-screening.
- Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA)
- Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation.
- Pregnancy or lactation. Female participants of childbearing potential with a fertile sexual partner must have a negative serum pregnancy test result at the screening visit. Women will be advised to use contraception for the duration of the study.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures.
- Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.
- Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants.
- Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
- Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
- Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year.
- Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
- Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial.
- Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period).
- Regular use of drugs that are CYP1A2 inhibitors (e.g. amiodarone, cimetidine, ciprofloxacin, fluvoxamine) or CYP1A2 inducers (e.g. carbamazepine, phenobarbital, rifampin, tobacco).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
M
Mathew N Leslie, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here