InsomniaEarly Phase 1Mela-NiaNCT06801379
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study
A Early Phase 1 study testing Inhaled Melatonin (100 μg) and Oral Melatonin (4 mg) in people with Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
Trial 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 the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Inhaled Melatonin (100 μg) and Oral Melatonin (4 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2025to 1 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, 2113
Grigori Kaplan, PhD, +61 2 9805 3232, grigori.kaplan@sydney.edu.au
Hui Xin Ong, PhD
About this study
Official title: A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia Disorder: a Randomised Open-Label Crossover Trial
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
Read the detailed description
This is a randomised open-label cross-over study of an inhaled formulation of melatonin (100 µg) versus oral melatonin tablets (4 mg) in adults with insomnia. The experiments performed for this trial will examine the effects of inhaled and oral drug delivery on the uptake and clearance of inhaled and oral melatonin.
To be enrolled in the trial, participants are required to complete an online pre-screening survey. Eligible participants will be directed to a separate webpage where they will be invited to review and download the Participant Information Sheet (PIS) and asked to provide their contact details and consent for a follow up call/email from the research team to book in a screening visit. At the screening visit, the study team will explain the study to each participant and provide the opportunity to ask any questions. The study team will also ensure participants have had ample time prior to the visit to read and understand the PIS. The consent form will be signed by both the participant and a medical officer and participants. Once participants have joined the efficacy study, they will be randomised into their first treatment group; inhaled melatonin (100 µg) or oral melatonin tablets (4 mg).
Participants will attend the laboratory for a daytime visit where they take the treatment once in the morning then remain at the laboratory over an approximately 8-hour period, providing blood samples every fifteen minutes during the first hour then hourly until 8 hours have passed since treatment. Participants will also be asked to rate their sleepiness on the Karolinska Sleepiness Scale each time blood is collected. There will be a 1 week washout period between treatments.
The study will recruit primarily through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Macquarie University, NSW, 2113, Australia.
- Conditions
- Insomnia
- Being tested
- Inhaled Melatonin (100 μg), Oral Melatonin (4 mg)
- Keywords
- Melatonin, Insomnia, Pharmacokinetics, Inhaled Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Melatonin (100 μg)Drug
Also called Melatonin, N-Acetyl-5-methoxytryptamine
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.
Oral Melatonin (4 mg)Drug
Also called N-Acetyl-5-methoxytryptamine, Circadin, Melatonin
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Melatonin Arm | Experimental | 100 µg daily of inhaled melatonin delivered by pressurized metered dose inhaler for two weeks before habitual bedtime. Receives: Drug: Inhaled Melatonin (100 μg) |
| Oral Melatonin Arm | Active comparator | 4 mg daily of orally delivered melatonin tablets for two weeks before habitual bedtime. Receives: Drug: Oral Melatonin (4 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximum Melatonin concentration
Time to peak concentration (Tmax) of blood-based melatonin, analysed by melatonin ELISA.
Measured: 0-8 hours post-treatment.
Secondary outcomes (4)
Melatonin area under the curve
Area under the curve (AUC) of blood-based melatonin analysed by melatonin ELISA.
Measured: 0-8 hours post-treatment.
Maximum blood-based melatonin concentration
Maximum concentration (Cmax) of blood-based melatonin, analysed by melatonin ELISA.
Measured: 0-8 hours post-treatment.
Melatonin half-life
Half-life (T½) of blood based melatonin, analysed by melatonin ELISA.
Measured: 0-8 hours post-treatment.
Daytime sleepiness
Participant subjective daytime sleepiness, determined by the Karolinska Sleepiness Scale, a 9-point Likert scale (ranging from "Extremely alert" = 1 to "Very sleepy, great effort to keep awake, fighting sleep" = 9).
Measured: Collected at t0 then every fifteen minutes during the first hour post-treatment, then once hourly until 8 hours post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, open-label, crossover trial
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woolcock Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Xin Ong, Woolcock Institute of Medical Research
- Investigators
- Hui Xin Ong, PhD, Principal investigator, Woolcock Institute of Medical ResearchRon Grunstein, MBBS MD PhD FRACP, Principal investigator, Woolcock Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801379
- Sponsor's protocol ID
- 520241811859849
- Acronym
- Mela-Nia
- Status last verified
- Jul 2024
- First submitted
- 24 Jan 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable IPD will be shared upon reasonable request to the Principal Investigators.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia Disorder: a Randomised Open-Label Crossover Trial
- ClinicalTrials.gov ID
- NCT06801379
- Acronym / sponsor ID
- Mela-Nia / 520241811859849
- Conditions
- Insomnia
- Keywords
- Melatonin, Insomnia, Pharmacokinetics, Inhaled Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Woolcock Institute of Medical ResearchUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a randomised open-label cross-over study of an inhaled formulation of melatonin (100 µg) versus oral melatonin tablets (4 mg) in adults with insomnia. The experiments performed for this trial will examine the effects of inhaled and oral drug delivery on the uptake and clearance of inhaled and oral melatonin.
To be enrolled in the trial, participants are required to complete an online pre-screening survey. Eligible participants will be directed to a separate webpage where they will be invited to review and download the Participant Information Sheet (PIS) and asked to provide their contact details and consent for a follow up call/email from the research team to book in a screening visit. At the screening visit, the study team will explain the study to each participant and provide the opportunity to ask any questions. The study team will also ensure participants have had ample time prior to the visit to read and understand the PIS. The consent form will be signed by both the participant and a medical officer and participants. Once participants have joined the efficacy study, they will be randomised into their first treatment group; inhaled melatonin (100 µg) or oral melatonin tablets (4 mg).
Participants will attend the laboratory for a daytime visit where they take the treatment once in the morning then remain at the laboratory over an approximately 8-hour period, providing blood samples every fifteen minutes during the first hour then hourly until 8 hours have passed since treatment. Participants will also be asked to rate their sleepiness on the Karolinska Sleepiness Scale each time blood is collected. There will be a 1 week washout period between treatments.
The study will recruit primarily through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Macquarie University, NSW, 2113, Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open-label, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Inhaled Melatonin Arm | Experimental | Drug: Inhaled Melatonin (100 μg)100 µg daily of inhaled melatonin delivered by pressurized metered dose inhaler for two weeks before habitual bedtime. |
| Oral Melatonin Arm | Active comparator | Drug: Oral Melatonin (4 mg)4 mg daily of orally delivered melatonin tablets for two weeks before habitual bedtime. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Melatonin (100 μg)Also: Melatonin, N-Acetyl-5-methoxytryptamineAn 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 | Inhaled Melatonin Arm |
| Oral Melatonin (4 mg)Also: N-Acetyl-5-methoxytryptamine, Circadin, MelatoninTwo 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. | Drug | Oral Melatonin Arm |
Primary outcome
Time to maximum Melatonin concentration
Time frame: 0-8 hours post-treatment.
Time to peak concentration (Tmax) of blood-based melatonin, analysed by melatonin ELISA.
4 secondary outcomes
Melatonin area under the curve
Time frame: 0-8 hours post-treatment.
Maximum blood-based melatonin concentration
Time frame: 0-8 hours post-treatment.
Melatonin half-life
Time frame: 0-8 hours post-treatment.
Daytime sleepiness
Time frame: Collected at t0 then every fifteen minutes during the first hour post-treatment, then once hourly until 8 hours post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Non-identifiable IPD will be shared upon reasonable request to the Principal Investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Xin Ong, PhD principal investigator
Woolcock Institute of Medical Research
Ron Grunstein, MBBS MD PhD FRACP principal investigator
Woolcock Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Inhaled Melatonin (100 μg) and Oral Melatonin (4 mg) in people with Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Xin Ong, PhD (0298053094, huixin.ong@mq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to maximum Melatonin concentration (time frame: 0-8 hours post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.