A study led by FloraWorks has announced the results of a double-blind, randomized, placebo-controlled trial that analysed the effects of its flagship product, TruCBN - a pure form of cannabinol (CBN) and one of more than 100 known cannabinoids found in the cannabis plant - on sleep.
Independently conducted by clinical-research company, Radicle Science, the groundbreaking research compared the effects of TruCBN against melatonin and a placebo, among more than 1,000 participants across the US. Each participant received one of three different doses: FloraWorks' TruCBN, melatonin or a placebo with the trial specifically finding that:
- The group taking 50 mg of TruCBN showed a significant improvement in sleep compared to placebo, and most of the group experienced a clinically important improvement.
- The group taking 4 mg melatonin also showed a significant improvement in sleep compared to placebo.
- The group taking 50 mg of TruCBN had slightly better sleep improvements compared to 4 mg of melatonin.
- The groups taking 25 mg and 100 mg of TruCBN had marginally significantly better sleep improvements compared to placebo.
- 50 mg of TruCBN delivered better sleep outcomes than 25 mg or 100 mg, which is the first clinical trial data to suggest TruCBN may have a U-shaped dose-response curve for sleep.
- All side effects were mild or moderate. There were no significant differences in the frequency of reported side effects between any dose of TruCBN or melatonin compared to placebo.
"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."
Radicle Science Co-founder and CEO Jeff Chen, MD/MBA said: "The historical firsts encompassed in this study, especially discovering that CBN may have a U-shaped dose-response curve, have tremendous implications for formulating effective, natural sleep products for Americans. The findings especially highlight the importance of using the right dosage. For CBN, both too much (100 mg) and too little (25 mg) may have decreased effectiveness."
Radicle Science VP of Research Affairs Dr Susan Hewlings, PhD, RD explained: "It's very promising to discover that CBN could be just as effective - and possibly better - than melatonin, considering many cannot tolerate melatonin's side effects. This discussion is especially timely given the recent FDA scrutiny towards melatonin dosage and concerns about children consuming melatonin above recommended doses."
Clinical findings like these from FloraWorks and Radicle Science have the potential to become major market disruptors to the legacy over-the-counter sleep aid market.
The historical firsts encompassed in this study, especially discovering that CBN may have a U-shaped dose-response curve
- Radicle Science CEO Jeff Chen, MD/MBA
Sixty percent (60%) of Americans report they get less than the recommended seven hours of sleep per night and poor sleep has become a public health concern as it is linked to many health issues, including inflammatory conditions, obesity, heart disease and overall reduced quality of life.
As consumers increasingly seek natural and safe alternatives for better sleep, the introduction of a non-intoxicating hemp-derived cannabinoid solution presents an attractive option. TruCBN could lead to a decline in demand for traditional sleep aids as the results of this study build consumer trust and confidence in TruCBN as a natural alternative sleep aid.