By Mike Montemarano, Associate Editor07.10.23
Cannabidiol (CBD), with or without the use of other minor cannabinoids including cannabinol (CBN) and cannabichromene (CBC), may help to improve sleep disturbances about as much as melatonin in a study published in the Journal of the American Nutrition Association.
The study was conducted by contract research organization Radicle Science with materials provided by cannabinoid company Open Book Extracts. A total of 1,298 participants who reported experiencing sleep disturbances at baseline were randomly assigned to take a 4-week supply of either 15 mg of CBD or 5 mg of melatonin alone, or a combination such as CBD/CBN, CBD/CBC, melatonin/CBD, and melatonin/CBD/CBN.
Nicole Brown, chief innovation officer at OBX, said the CBN and CBC were selected due to their prominence in the market compared to other minor cannabinoids, as well as their possible potentiating roles in sleep support applications.
“The existing literature on CBN suggests that there may be some relaxing and sleep-supporting qualities to it, and CBC is thought to have a potentiating effect where when included in a formula, it can enhance the other cannabinoids in the formulation. It’s encouraging to see the synergy and relationship between minor cannabinoids displayed in this study, especially for the development of full-spectrum products.”
Sleep disturbances were measured over a period of 5 weeks, including a baseline week at the beginning of the study prior to product use, via online participation in a questionnaire which measured PROMIS Sleep Disturbance indices. All formulations were found to be safe, with 12% of participants reporting non-severe side effects, and all significantly improved sleep disturbances according to PROMIS scores.
There were no significant differences in effects between CBD on its own or in combination with CBN or CBC, or between these three groups and the melatonin group. While melatonin combined with CBD and CBN had the greatest impact on sleep disturbance, it was not significantly greater than that achieved by any of the CBD groups.
At baseline, 37%, 23%, 32%, and 8% of participants had slight, mild, moderate, and severe sleep disturbances, respectively. By the end of the study, 67% of participants in total experienced a minimal clinically important difference (MCID) in PROMIS sleep quality stores.
“Notably, all study arms led to significant improvements in sleep disturbance and exhibited favorable safety profiles,” the authors wrote.
“Despite the limited clinical evidence, marketing claims regarding the effectiveness of CBD for sleep abound,” the authors wrote. “Many manufacturers have also touted the superiority of their CBD sleep products in relation to melatonin, though, to date, no clinical study [besides the present study] has directly compared the effects of these compounds on sleep.”
Brown said the central focus of the OBX/Radicle Science partnership has been to put doses of cannabinoids found in everyday commercial products to the test with statistical power never before seen.
“We’re a product development house and manufacturing provider so we understand that we need the science to represent the kind of business that we’re in,” she said. “Being able to draw favorable conclusions on the kinds of products that are available on the market is very important for the consumer products segment of the cannabinoids industry.”
“There’s been a rise in the popularity of CBD for sleep applications globally, and we wanted to validate that anecdotal evidence from consumers around the world, especially with more minor cannabinoids, at a scale that has never been done,” Brown said. “The at-home survey data that we leveraged helped us to have 200 to 300 participants in each arm of the 6-arm study, which is several times larger than most studies on CBD and minor cannabinoids that have taken place. So the population at large was one of the biggest strengths of the study.”
The study’s design also enabled a longer duration, and at-home evaluations showed that benefits could be sustained in a more realistic environment than a sleep lab, Brown noted.
“We saw that outcomes improved gradually over time which was important to further validate the benefits of these cannabinoids. We saw improvements in hours of sleep per night within the first two weeks, but it was really important to see that sustained and continued improvement. The real-world setting was another strength of this study, as you need to see that sleep support products can sustain benefits within the regular course of a person’s routine, including the stressors and events at home that might not take place in a sleep lab.”
“Many traditional clinical trials of natural products are limited by smaller sample sizes and have limited external validity because the characteristics and behaviors of participants may not reflect those of real-world users,” the authors concurred in the conclusion of the study.
The study was conducted by contract research organization Radicle Science with materials provided by cannabinoid company Open Book Extracts. A total of 1,298 participants who reported experiencing sleep disturbances at baseline were randomly assigned to take a 4-week supply of either 15 mg of CBD or 5 mg of melatonin alone, or a combination such as CBD/CBN, CBD/CBC, melatonin/CBD, and melatonin/CBD/CBN.
Nicole Brown, chief innovation officer at OBX, said the CBN and CBC were selected due to their prominence in the market compared to other minor cannabinoids, as well as their possible potentiating roles in sleep support applications.
“The existing literature on CBN suggests that there may be some relaxing and sleep-supporting qualities to it, and CBC is thought to have a potentiating effect where when included in a formula, it can enhance the other cannabinoids in the formulation. It’s encouraging to see the synergy and relationship between minor cannabinoids displayed in this study, especially for the development of full-spectrum products.”
Sleep disturbances were measured over a period of 5 weeks, including a baseline week at the beginning of the study prior to product use, via online participation in a questionnaire which measured PROMIS Sleep Disturbance indices. All formulations were found to be safe, with 12% of participants reporting non-severe side effects, and all significantly improved sleep disturbances according to PROMIS scores.
There were no significant differences in effects between CBD on its own or in combination with CBN or CBC, or between these three groups and the melatonin group. While melatonin combined with CBD and CBN had the greatest impact on sleep disturbance, it was not significantly greater than that achieved by any of the CBD groups.
At baseline, 37%, 23%, 32%, and 8% of participants had slight, mild, moderate, and severe sleep disturbances, respectively. By the end of the study, 67% of participants in total experienced a minimal clinically important difference (MCID) in PROMIS sleep quality stores.
“Notably, all study arms led to significant improvements in sleep disturbance and exhibited favorable safety profiles,” the authors wrote.
Real-World Applications
Prior to this clinical trial, only small studies existed to support the potential use of CBD for sleep support, and most used high doses ranging from 160 mg to 1,200 mg daily.“Despite the limited clinical evidence, marketing claims regarding the effectiveness of CBD for sleep abound,” the authors wrote. “Many manufacturers have also touted the superiority of their CBD sleep products in relation to melatonin, though, to date, no clinical study [besides the present study] has directly compared the effects of these compounds on sleep.”
Brown said the central focus of the OBX/Radicle Science partnership has been to put doses of cannabinoids found in everyday commercial products to the test with statistical power never before seen.
“We’re a product development house and manufacturing provider so we understand that we need the science to represent the kind of business that we’re in,” she said. “Being able to draw favorable conclusions on the kinds of products that are available on the market is very important for the consumer products segment of the cannabinoids industry.”
“There’s been a rise in the popularity of CBD for sleep applications globally, and we wanted to validate that anecdotal evidence from consumers around the world, especially with more minor cannabinoids, at a scale that has never been done,” Brown said. “The at-home survey data that we leveraged helped us to have 200 to 300 participants in each arm of the 6-arm study, which is several times larger than most studies on CBD and minor cannabinoids that have taken place. So the population at large was one of the biggest strengths of the study.”
The study’s design also enabled a longer duration, and at-home evaluations showed that benefits could be sustained in a more realistic environment than a sleep lab, Brown noted.
“We saw that outcomes improved gradually over time which was important to further validate the benefits of these cannabinoids. We saw improvements in hours of sleep per night within the first two weeks, but it was really important to see that sustained and continued improvement. The real-world setting was another strength of this study, as you need to see that sleep support products can sustain benefits within the regular course of a person’s routine, including the stressors and events at home that might not take place in a sleep lab.”
“Many traditional clinical trials of natural products are limited by smaller sample sizes and have limited external validity because the characteristics and behaviors of participants may not reflect those of real-world users,” the authors concurred in the conclusion of the study.
