A new study from cannabinoid therapeutics company FloraWorks announced the results of the first trial that studied the effects of its flagship TruCBN™, a pure form of cannabinol (CBN), on sleep.
The double-blind, randomized, placebo-controlled trial, independently conducted by clinical research company Radicle Science compared the effects of TruCBN against melatonin and placebo. The study recruited 1,000 participants across the United States with each participant receiving a dose of one of either FloraWorks’ TruCBN, melatonin or a placebo. While CBN may not have the same exposure as some of the other over 100 cannabinoids (according to the Global Drug Survey, only 2.5 percent of cannabis users reported having used CBN) it has long been linked to wellness efforts and its sedative nature makes it a prime candidate to help with sleep disorders and disturbances.
Results from the trial found the group that took 50 mg of TruCBN showed significant improvement in sleep compared to the placebo, with most in the TruCBN group experiencing a clinically important improvement in sleep. While the group that took four mg of melatonin also showed improvement compared to placebo, the group taking the 50 mg of TruCBN showed slightly better sleep improvements. Results showed 50 mg of TruCBN delivered better sleep outcomes, demonstrating a possible U-shaped dose-response curve for sleep.
“Our results pave the way for developing more effective sleep solutions, ultimately improving the quality of life for millions of people who struggle with sleep disturbances,” said FloraWorks CEO and Cofounder Alleh Lindquist. “These findings bring needed clarity to the rapidly growing consumer demand for existing CBN products. Our TruCBN will be a new competitor in the global sleep aid market and marks a major milestone in building consumer trust and confidence in the therapeutic potential of cannabinoids.”
FloraWorks recently completed a successful Series A funding round in which the company raised $2.25 million, led by Bonaventure Equity LLC (“BVE”) and with participation from ArcView Group. FloraWorks said the funding will be used to advance their research and help with the development of a pipeline of rare and novel cannabinoids that can be used to address unmet needs for a variety of sleep and other neurological disorders.
“We’re excited to partner with Alleh and the FloraWorks team as we continue to look for companies that are way ahead of the market in terms of building pharmaceutical-quality products,” said BVE Founder and Managing Partner Ross O’Brien. “FloraWorks is uniquely positioned to further its mission of bringing the benefits of cannabinoid therapeutics to people around the world and has been successful in expanding the cannabinoid consumer markets with high-quality efficacious products, while also successfully completing research studies with proprietary molecules in partnership with leading research organizations.”
A previous study published in the Journal of American Nutrition Association found a daily administration of 15 mg of CBD improves the quality of sleep for people with a history of sleep disturbances. A total of 56 to 75 percent of participants reported “clinically important improvement to their sleep quality” according to the study, however, authors also note that there were “no significant differences in effect” between a 15 mg CBD isolate formulation and formulations containing 15 mg of CBD and 15 mg of CBN, alone or combined with 5 mg of CBC.
“There were also no significant differences in effect between 15 mg CBD isolate and formulations containing 5 mg melatonin, alone or in combination with 15 mg CBD and 15 mg CBN,” authors state. “Our findings suggest that chronic use of a low dose of CBD is safe and could improve sleep quality, though these effects do not exceed that of 5 mg melatonin. Moreover, the addition of low doses of CBN and CBC may not improve the effect of formulations containing CBD or melatonin isolate.”
