Australia-based therapeutics company Zelira Therapeutics Ltd has revealed the success of their recent medicinal cannabis trial for the treatment of Insomnia. It was announced that the trial met both its primary and secondary endpoints as the company received the final clinical report for the trial. 

Zelira Therapeutics Ltd

Zelira Therapeutics Ltd (formerly Zelda Therapeutics) is currently developing medicinal cannabis products for a variety of conditions including Insomnia, Autism, and opioid reduction. The company has currently released two products under the HOPE brand in multiple US states, with hopes to launch in the global market this year.

Dr. Richard Hopkins, Managing Director, ex-US markets, at Zelira Therapeutics, said:

“We are delighted as these results have exceeded our expectations. Globally we are the first company to take a full-spectrum cannabis product and test it for efficacy in the insomnia space.”

What is Insomnia?

Insomnia is a sleep disorder, which causes people to have trouble getting to sleep or staying asleep. Experts often link the disorder to stress and anxiety levels. Insomnia can also cause prolonged tiredness throughout the day, feeling irritable and unable to concentrate.

It is estimated that only a third of people in the UK are classified as “good sleepers”. The UK’s Mental Health Foundation also found that a third of people in the UK could possibly have Chronic Insomnia.

How Could Cannabis Treat Insomnia?

Cannabinoids found within the cannabis plant have been consistently linked with relieving stress and anxiety levels. It is thought that some of the compounds found in Cannabis, particularly CBD, can potentially encourage the body to release anxiety-easing chemicals.

In addition, THC – the primary psychoactive cannabis compound – may also help to induce sleep. Some previous studies have revealed that THC reduces the amount to REM sleep. This is the section of sleep in which we dream. This finding has prompted some theorists to think that cannabis could reduce nightmares in patients suffering from PTSD-induced Insomnia.

Zelira Therapeutics Medicinal Cannabis Insomnia Trials

In their trial, Zelira Therapeutics Ltd assessed the effects of their cannabis product ZLT-101 on 23 patients. Each patient was given either a 0.5ml (11.5mg of cannabinoids) or 1ml (23mg of cannabinoids) dose over 14 nights.

After a seven-night ‘wash-out period’, patients were then given a placebo dose for an additional 14 nights. The results showed that medicinal cannabis produced “statistically significant and dose responsive improvements” in Insomnia Severity Index (ISI) scores compared to the placebo.

In this double-blind placebo-controlled trial, patients experienced an average ISI score decrease of 26%. In addition, the trial also demonstrated that the effects of ZLT-101 may also be dose-dependent. Patients who received a higher dose demonstrated a higher average ISI score decrease of 36%.

What Next?

Following the positive results from clinical trials, Zelira Therapeutics is expecting to launch on the Australian market in 2020. It will also look to further develop ZLT-101 trials with a view of registering the product in Australia.