Insomnia is estimated to affect 70 million Americans and by 2022 consumer spending on over-the-counter medications is expected to exceed $4 billion. And there is potential that a portion of that money, invested in a better night’s sleep, will purchase a cannabis derived product.
A privately funded sleep study using medicinal cannabis, that began in 2018 by the University of Western Australia’s (UWA) Centre for Sleep Science, shows some promising results as an alternative to taking engineered pharmaceuticals. Zelira Therapeutics provided the funding for the study and Professor Peter Eastwood was the lead investigator.
The trial consisted of twenty-three patients who were treated for 14 nights with Zelira’s proprietary cannabis formulation (ZTL-101), and 14 nights with a placebo. There was a one-week “washout” period between the different treatments. The ZTL-101 was administered in the form of an oil and taken by placing drops under the tongue.
New Atlas reported the ZTL-101 formulation is a mixture of THC and CBD, but the exact ratio is not known. The patients had the option of taking a single dose (0.5ml of 11.5mg total cannabinoids) or a double dose for more extreme sleeping disorders (1 ml of 23mg total cannabinoids).
The team measured sleep quality from wrist-based sleep trackers, subjective responses, and a clinical questionnaire called the Insomnia Severity Index (ISI). The results of the study showed significant improvements in overall time slept and the patients noted feeling more rested upon waking.
Across all participants, the ISI scores dropped by 26% and participants who took the higher dose showed a 36% reduction in symptoms. This shows that not only was the ZTL-101 effective, it was also dose-responsive. Compared to the placebo that was administered, the formulation showed a significant reduction in ISI scores at all doses. Participants reported, “only minor adverse events” that included dry mouth and headaches.
Professor Eastwood talks about the importance of this study:
This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia. The fact that ZLT-101 treatment achieved statistically significant, dose-responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window. It is likely that further improvements in efficacy could be achieved by dosing over a longer period and potentially at higher doses.
Dr. Richard Hopkins, the Managing Director ex-US markets also commented:
We are delighted as these results have exceeded our expectations. The trial has yielded a comprehensive data-pack that supports our plans to launch the world’s first clinically validated insomnia product into global markets in 2020. In addition to insomnia, we’ll also be targeting indications such as chronic pain, mental and neurological disorders where insomnia is recognized as a key risk factor for disease.
This is quite exciting news for the millions of people who have trouble sleeping. Regular cannabis users have long understood the benefits it can have on sleep, especially Indica, which offers more relaxing benefits than uplifting Sativa.
Zelira Therapeutics said they will “seek to deploy its Launch, Learn and Develop strategy to supply its clinically validated insomnia formula,” in countries where medicinal cannabis is currently legal including, Australia, the U.S., Germany, and the UK. The company is also planning further clinical trials of ZTL-101 to gain product registration within Australia.
Zelira is also involved in a program called HOPE™ to perform clinical trials focused on insomnia, autism, and opioid reduction in the U.S. and Australia. Trials are conducted in both Pennsylvania and Louisiana in the U.S.
For further information, you can visit zeliratx.com
