Clinical research programme
Sleep disturbance is one of the most persistent and under-addressed health challenges, affecting wellbeing, productivity, mental health and quality of life.
At OMG Pharma, we are focused on developing clinically credible, patient-centred solutions for sleep — supported by structured research, ethical oversight and a commitment to evidence generation.
75 mg
CBD per oral dissolving tablet
2
Clinical studies: pharmacokinetics and insomnia trial
Double-blind
Placebo-controlled OMG-100 study in adults with insomnia disorder
Many people experiencing sleep difficulties are left with limited options. Existing treatments may be unsuitable for long-term use, poorly tolerated, associated with dependency concerns, or used off-label. This creates a clear need for new approaches that are:
OMG Pharma’s sleep research programme includes:
Pharmacokinetic research
A Phase I study investigating how OMG’s 75 mg CBD oral dissolving tablet is absorbed and processed in healthy volunteers. The study is designed to assess plasma levels of CBD and related metabolites over time.
Insomnia clinical trial
A randomised, double-blind, placebo-controlled study evaluating OMG-100 in adults with insomnia disorder. The study is designed to assess insomnia severity, sleep parameters, mood-related measures, safety and tolerability.
Our clinical programme reflects a clear goal: to generate meaningful evidence while protecting confidential research, participant privacy and future intellectual property.
We are not simply developing products for sleep. We are building the evidence base to support informed clinical decision-making.
Research collaboration
OMG Pharma’s sleep programme is delivered with experienced academic investigators under appropriate human research ethics oversight.
Lead Researcher · NICM Health Research Institute
Mike Armour is Associate Professor in Reproductive Health and Director of Research at the NICM Health Research Institute, Western Sydney University. He is an internationally recognised clinical investigator with a focused interest in medicinal cannabis, having led four prior clinical studies in the field and authored more than 140 peer-reviewed publications.
His research informs Australian clinical guidelines and is cited in international evidence-based resources such as UpToDate. Mike leads the clinical research collaboration with OMG Pharma at NICM, Western Sydney University.
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OMG Pharma is investing in clinical research to better understand the role of cannabidiol-based formulations in sleep health. The programme includes a Phase I pharmacokinetic study of OMG’s 75 mg CBD oral dissolving tablet and a randomised, double-blind, placebo-controlled clinical trial evaluating OMG-100 in adults with insomnia disorder. Together, these studies are designed to assess absorption, clinical outcomes, safety and tolerability in a structured, ethically overseen way.
The sleep research programme currently includes two studies:
Eligibility depends on the specific study. The Phase I pharmacokinetic study involves healthy volunteers, while the insomnia trial is designed for adults with insomnia disorder. Full inclusion and exclusion criteria are assessed during screening for each study. Participation requires informed consent and compliance with all protocol requirements.
The programme includes OMG’s 75 mg CBD oral dissolving tablet in the Phase I pharmacokinetic study, and OMG-100 in the insomnia clinical trial. These studies are investigational and are intended to generate evidence on safety, pharmacokinetics and clinical outcomes — not to promote product availability.
Outcomes vary by study. The pharmacokinetic study focuses on how CBD is absorbed and processed in the body. The insomnia trial is designed to assess insomnia severity, sleep parameters, mood-related measures, safety and tolerability. Together, the programme aims to build a clearer evidence base to support informed clinical decision-making.
Studies are conducted under appropriate human research ethics oversight. Ethics approval for the insomnia research programme has been granted by the Western Sydney University Human Research Ethics Committee, with approval extended until 8 October 2026. Safety monitoring, informed consent and investigator oversight are embedded throughout each study protocol.
For general enquiries about OMG Pharma sleep research, use our contact form or email info@ozmedicann.com. OMG Pharma will share appropriate updates as the programme progresses. Registering interest does not guarantee eligibility or enrolment in any study.
