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
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.
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.
Crossover
Inhaled Melatonin (100 μg)
DrugAn 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)
DrugTwo 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.
Time to maximum Melatonin concentration
Time to peak concentration (Tmax) of blood-based melatonin, analysed by melatonin ELISA.
Melatonin area under the curve
Area under the curve (AUC) of blood-based melatonin analysed by melatonin ELISA.
Maximum blood-based melatonin concentration
Maximum concentration (Cmax) of blood-based melatonin, analysed by melatonin ELISA.
Melatonin half-life
Half-life (T½) of blood based melatonin, analysed by melatonin ELISA.
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).
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