Research Centre: Woolcock Institute of Medical Research
Location: 2 Innovation Road, Macquarie Park 2113 NSW
Lead Researcher: Dr Hui Xin Ong
HREC: This study has been reviewed and approved by the Macquarie University HREC

Struggling to fall asleep (or stay asleep) can leave you drained and frustrated. Researchers at the Woolcock Institute of Medical Research are exploring a new approach that could help.

This clinical study is testing an inhaled form of melatonin designed specifically for adults aged 55 and older who have been diagnosed with insomnia. By taking part, you’ll contribute to vital research aimed at finding fresh options for people facing the nightly challenge of insomnia. Be Part of the discovery. Join now!

• Participants will receive a new investigational treatment for insomnia and sleep-related health at no cost.
• Participants will be compensated up to $200 per study for participating in this study. The compensation amount will be adjusted depending on the duration and level of participation.
• Participants may experience sleep-related improvements. 
• Participants will be contributing valuable information that may benefit those with insomnia in the future.
• Participants will be helping to advance medical research.

• You will receive a detailed outline of all details of the study, including treatment, risks, and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.

Participate in a Study Testing a Novel Inhaled Melatonin Treatment for Adults With Insomnia

Who Can Participate:

• Must be 55 years or older.
• Must be diagnosed with insomnia disorder
• Must have trouble falling asleep that typically takes 30 minutes or longer on at least 3 nights a week over the past month.
• Must be able to read and understand English.

• Must be able to attend the research centre for approximately 6 study visits over about 2 months

Who Cannot Participate:

• Must not have untreated moderate to severe sleep apnea (breathing stops or slows during sleep), though well-treated sleep apnea with insomnia is acceptable.
• Must not have certain sleep or mental health conditions, including circadian rhythm disorders, narcolepsy, severe restless legs, REM sleep behavior disorder, uncontrolled psychiatric illness, recent suicidal thoughts or attempts, or significant memory or thinking problems.
• Must not be pregnant or breastfeeding. Women who could become pregnant must agree to use birth control during the study.
• Must not work regular night shifts, have recent jet lag or long-distance travel, or have taken part in another drug/device study within the last month.
• Must not regularly use certain medications or substances, including:
  • Sleep aids such as melatonin, valerian, kava, benzodiazepines, Z-drugs, or sedating antihistamines within the past two weeks.
  • Stimulants (e.g., ADHD medications or modafinil-type drugs) within the past two weeks.
  • Strong antidepressants were started or changed in the past year.
  • Opioids within the past two weeks.
  • Cannabis (THC or CBD) within the past two weeks.
  • Drugs or alcohol to a level considered dependence in the past two years (alcohol limited to no more than 2 standard drinks per day during the trial).
  • Certain prescription medicines that strongly affect the liver enzyme CYP1A2 (examples include amiodarone, cimetidine, ciprofloxacin, fluvoxamine, carbamazepine, phenobarbital, rifampin, or tobacco).
• Must not have any other serious condition that, in the investigator’s opinion, would make participation unsafe or prevent completing the study requirements.

Woolcock Institute of Medical Research
The Woolcock Institute of Medical Research is a world-leading, not-for-profit Australian research institute dedicated to improving respiratory and sleep health through research, clinical care, and education. Established by Professor Ann Woolcock in 1981, the institute is recognised globally for its research into conditions like asthma, COPD, sleep apnea, and lung cancer, with the goal of translating scientific discoveries into better treatments and patient outcomes.

The study team will explain the research in its entirety, but some details include:

• Participants will be asked to complete questionnaires and interviews, including demographics, medical history, current medications, the Insomnia Severity Index, and the Karolinska Sleepiness Scale.
• Participants will be asked to take either an inhaled melatonin product (100 microgram dose) or an oral melatonin product (4 milligram dose) during the study.
• Participants will be asked to undergo health assessments such as a comprehensive physical exam (height, weight, vital signs) and the Montreal Cognitive Assessment (MoCA).
• Participants will be asked to provide blood samples for melatonin testing and report any side effects or adverse events throughout the study.

Participate in a Study Testing a Novel Inhaled Melatonin Treatment for Adults With Insomnia