Research in Progress: CBD for Insomnia Needs Participants
In a groundbreaking development, Avecho Biotechnology Limited is spearheading the largest clinical trial ever conducted in Australia for treating insomnia with a pharmaceutical-grade CBD product. This Phase III, placebo-controlled trial is currently recruiting over 500 patients across multiple cities, including Melbourne, Sydney, Gold Coast, and Perth [1][4].
The trial, named 'The Trial', is a significant step forward in the investigation of CBD as a potential treatment for insomnia. The proprietary product being tested is an oral soft-gel capsule enhanced with a Tocopheryl Phosphate Mixture (TPM®), aimed at addressing key challenges in CBD therapeutics, such as limited bioavailability, stability, and dosage form [1].
Dr. Paul Gavin, CEO of Avecho, expressed his excitement about working with clinical experts across Australia to recruit for the trial. He highlighted the importance of this research, stating, "This trial represents the most advanced and largest CBD insomnia therapeutic investigation in Australia to date, aiming to provide robust clinical data on safety and efficacy for regulatory approval and market introduction" [1][4].
Recruitment efforts for 'The Trial' began during Sleep Health Week in mid-August 2025. The study is positioned as a benchmark for future CBD insomnia research, thanks to its substantial patient cohort and rigorous methodology [1][4][2].
The trial has received significant backing from the global pharmaceutical company Sandoz AG, indicating strong industry support [1]. It builds on earlier 2024 trials, such as the Evrima-Avecho CBD TPM study, which showed subjective wellbeing improvements in insomnia patients, helping to validate this approach [2].
Cannabidiol (CBD), the major non-psychoactive chemical found in the cannabis plant, is being studied for its potential to treat various conditions, including epilepsy, pain, anxiety, and insomnia. If successful, Avecho's over-the-counter (OTC) CBD product could potentially revolutionise the treatment landscape for insomnia in Australia.
The Australian Therapeutics Goods Administration (TGA) implemented a key policy change in 2020, allowing oral pharmaceutical CBD products to be registered as OTC medicines in Australia. This change offers a significant access and safety advantage over unregistered medicinal cannabis products [1].
Insomnia affects a substantial portion of the Australian population, with almost 60% reporting symptoms. On a global scale, insomnia affects between 10-30% of the population, with 10-15% classified as chronic. Poor sleep contributes to an estimated total cost of $19.1 billion to the Australian economy, with productivity losses accounting for $11 billion [1].
If Avecho's trial proves successful, it could make the company the first to register a pharmaceutical CBD product for sleep anywhere in the world. This development could significantly impact the lives of millions of people struggling with insomnia, offering a potential solution to a widespread problem.
The Trial's groundbreaking investigation of CBD as a potential treatment for insomnia, particularly its use of an oral soft-gel capsule enhanced with TPM®, could revolutionize the health-and-wellness industry and mental-health care, providing a safe and effective solution for insomnia patients. If successful, this advancement in science could lead to the registration of the first pharmaceutical CBD product for sleep, potentially impacting the lives of millions worldwide and reducing the economic burden of insomnia.
