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

Launched by WOOLCOCK INSTITUTE OF MEDICAL RESEARCH · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help adults with insomnia using an inhaled form of melatonin, a hormone that helps regulate sleep. The researchers want to find out if this inhaled version works differently in the body compared to traditional melatonin tablets taken by mouth. Specifically, they will measure how quickly the inhaled melatonin reaches the bloodstream and how long it stays there, compared to the oral tablets.

To participate, individuals must be at least 55 years old and have a diagnosed sleep disorder, which means they struggle to fall asleep, stay asleep, or wake up too early at least three times a week for at least three months. Participants will visit the research site three times, where they will take either inhaled melatonin or oral melatonin on different days and provide blood samples over an eight-hour period. It's important to note that certain health conditions or medications may disqualify someone from joining the trial. If you're interested, be sure to discuss your eligibility with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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).