Sleep quality improves when combining CBD and melatonin, finds landmark clinical trial

30 Sep 2022 --- AI-driven health-tech company Radicle Science and Open Book Extracts (OBX) have released the results of “history’s largest clinical trial researching CBD for sleep outcomes and the largest trial of cannabinol (CBN)-containing products.”

The trial aimed to evaluate the effects of different CBD products relative to melatonin, finding that sleep length and quality improved when combined. NutritionInsight speaks with the CEOs of Radicle Science and OXB on the new findings and what it means for the industry.

“Melatonin is the most studied, proven and widely used non-prescription sleep supplement. It was surprising that the sleep improvement on melatonin alone was not significantly different from most cannabinoid products studied. There were also some surprising preliminary signs in this study to suggest that some cannabinoid products may cause less grogginess than melatonin,” says Dr. Jeff Chen, CEO of Radicle Science.

“Formulations with cannabinoids may potentially confer more pain and anxiety benefits compared to melatonin alone, although much more research into this is needed.”

Prolonged sleep for the majority
In the blinded, randomized and controlled clinical trial, 1,800 people across the US participated. Five products were tested, all containing CBD and some with additional rare cannabinoids such as CBN and cannabichromene. One product contained an extra 5 mg of melatonin. All products were compared to the control product containing only 5 mg melatonin.

Four out of five CBD products showed sleep improvement compared to using melatonin alone.The distribution was randomized as the participants were given one of the products for daily consumption over four weeks. The measurement was done by regular reporting on usage, sleep quality, side effects and other health outcomes such as anxiety or pain.

Out of five products tested, four showed sleep improvement compared to using melatonin alone as additional minutes of sleep range from 34 to 76 minutes per night, although with no statistical significance. There was no difference in the frequency of side effects between products.

“While we expected perhaps one or two of the products might show clinically meaningful improvement, we were surprised at how well all cannabinoid products performed as compared with melatonin. Further, it was promising to see the same products provide improvement for pain or anxiety in addition to their sleep disturbance,” says Dave Neundorfer, CEO at OBX.

Suitable for all?
Chen explains that CBD should be avoided by heavy alcohol consumers or people suffering from liver disease, as it may pose health risks. He adds that CBD acts similarly to grapefruit in its interaction with certain medications. Therefore, anyone taking a medication with a grapefruit warning should avoid CBD.

“There have been studies testing CBD from 100 mg to an excess of 1000 mg daily, and they have found it to be generally well-tolerated and safe. However, certain types of individuals need to be careful about CBD usage,” he continues. 

“We do not know the effects of CBD on pregnancy or young children, so women who are trying to conceive, currently pregnant, or nursing their young with breastmilk should avoid CBD until we have more information.”

The effects of CBD on pregnancy and young children is still unknown and should therefore be avoided, Chen stresses.Neundorfer explains that in general, cannabinoids have the potential to be the preferred alternative solution to a variety of health and wellness need-states, and melatonin is only the first of many products that will be dethroned by cannabinoids.

“There are currently no known adverse interactions between CBD and melatonin, although this is an area of limited research. Taking melatonin and CBD together might lead to more sedation or lethargy. However, in the study, the group taking a product with both CBD and melatonin had a low incidence of generally mild side effects. Moreover, this group did not have a significant difference in the total side effects reported compared to the melatonin-only group,” Chen underscores.

Cruciality of quality sleep
Prior research on sleep disturbance has shown potential adverse effects such as increased snacking of fat and sugar. There has also been an increased consumer interest in the link between sleep and nutrition, calling for more research on CBD and magnesium.

“With so many suffering from acute and chronic sleep issues, the field for natural products to improve and support better sleep quality continues to grow,” adds Neundorfer. 

“These data support that cannabinoid products can be as effective as traditional sleep aides like melatonin, which allows for the development of enhanced therapeutically focused products and simultaneously builds consumer trust in pursuing cannabinoid products as an alternative to traditional sleep aides like melatonin.”

By Beatrice Wihlander