Clinical focus on sleep

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.

Why sleep?

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:
  • Evidence-informed
  • Well tolerated
  • Practical for real-world use
  • Designed with patient experience in mind

Our research approach

OMG Pharma is investing in clinical research to better understand the role of cannabidiol-based formulations in sleep health.

Our programme is designed to evaluate safety, pharmacokinetics and clinical outcomes in a structured, ethical and scientifically robust way.

This includes collaboration with experienced research partners and studies conducted under appropriate human research ethics oversight. Ethics approval for the insomnia research programme has been granted by Western Sydney University Human Research Ethics Committee, with approval extended until 8 October 2026.

Clinical research in progress

OMG Pharma’s sleep research programme includes:

Pharmacokinetic research

Phase I bioavailability study

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

OMG-100 in adults with insomnia disorder

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.

Clinical research in progress

OMG Pharma’s sleep research programme includes:

Pharmacokinetic research

Phase I bioavailability study

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

OMG-100 in adults with insomnia disorder

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.

Built on responsible innovation

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.

Stay informed

Meet our research partners

OMG Pharma’s sleep programme is delivered with experienced academic investigators under appropriate human research ethics oversight.

Mike Armour

Lead Researcher · NICM Health Research Institute

Associate Professor Mike Armour, PhD

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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Receive future clinical updates

OMG Pharma will share appropriate updates as our sleep research programme progresses. Register your interest to receive future clinical updates from OMG Pharma.