The study, which included 1,793 adults experiencing symptoms of sleep disturbance, also found that adding low-dose cannabinol (CBN) or cannabichromene (CBC) to CBD didn’t enhance the effects.
“These findings represent an essential scientific advancement toward thoroughly characterizing and contrasting the comparative effectiveness of commonly used non-prescription sleep disorder treatments,” wrote scientists from Radicle Science, the University of Pittsburgh, the University of Maryland School of Medicine, the University of California Los Angeles, and Scripps Clinic Sleep Center in the Journal of the American Nutrition Association.
Jeff Chen, MD, CEO and co-founder of Radicle Science and co-author on the new paper, told NutraIngredients-USA that, despite CBD's widespread anecdotal use for sleep disturbances, there has been a notable lack of peer-reviewed rigorous clinical trials demonstrating CBD's effectiveness for sleep disturbance.
“To address this scientific gap, we conducted a first-of-its-kind clinical trial comparing the effectiveness of different orally ingested cannabinoid and melatonin formulations for sleep disturbance, involving an unprecedented 1,793 adults,” said Dr Chen.
“This trial is history's first double-blind, randomized, controlled sleep trial to compare the effects of any cannabinoids (including CBD) against melatonin, and to investigate combination of cannabinoids and melatonin,” he added. “This trial also represents history's largest double-blind, randomized, controlled trial of cannabinoids in general.
“Given melatonin is the one of the most widely researched non-prescription sleep aids, these findings offer novel insights and options for optimizing sleep quality by contributing significantly to the understanding of CBD's potential role in improving sleep, its effectiveness relative to melatonin, and any changes in effectiveness from combining cannabinoids and melatonin.”
Sleep supplements category
The US market for dietary supplements to support sleep is dominated by melatonin, which was responsible for 91.5% of all sleep supplement sales, according to SPINS.
The category has experienced impressive growth over the past few years. Sales of sleep supplements increased 40% and 22% in 2020 and 2021, respectively, to hit $737 million (SPINS data). A slight decline in dollar sales of 4.2% was recorded in 2022 for the Natural and Mass channels, but the market is still a significantly bigger category than in 2019 when it was valued at $432 million.
The new study shows the potential for CBD to offer an efficacious alternative to melatonin.
The researchers recruited 1,793 adults experiencing symptoms of sleep disturbance and randomly assigned them to receive one of six products (all capsules) for four weeks. The groups were: 15 mg CBD isolate alone; 5 mg melatonin alone; 15mg CBD + 15 mg CBN + 5 mg melatonin; 15mg CBD + 15 mg CBN + 5 mg CBC; and 15mg CBD Full Spectrum + 15 mg CBN. All products were provided by Open Book Extracts.
Sleep was assessed the using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance SF 8A. Participants completed this survey weekly.
“Our results suggest that either 15mg of CBD or 5mg melatonin could meaningfully improve sleep quality, although neither was significantly better than the other,” Dr Chen told us. “We further found that adding low doses of CBN and CBC to 15mg of CBD may not enhance CBD's effectiveness for sleep disturbance.”
“The results also suggest that adding low doses of CBD and CBN to 5mg of melatonin may not enhance melatonin's effectiveness for sleep disturbance.”
Commenting on the lack of effect for CBN, a cannabinoid that has been touted by marketers to offer sleep benefits, the researchers noted that the new study is the “first clinical trial to evaluate the use of CBN for sleep using validated sleep measures.
“Our findings suggest that 15 mg of CBN may confer little added benefit to a sleep aid product. We note, however, that our findings reflect a relatively lower dosage of orally ingested CBN and may not be generalizable to higher dosages or other modes of administration of the cannabinoid,” they added.
“Real world studies have unique value”
The researchers also noted that the data presented is “real world” data, “as it was collected from a population that was using the products in a manner and setting like that of real consumers of these products. […] real world studies have unique value in their ability to provide complementary evidence to support clinical trial designs and help guide regulatory and clinical decisions.”
Source: Journal of the American Nutrition Association
Published online ahead of print, doi: 10.1080/27697061.2023.2203221
“The Safety and Comparative Effectiveness of Non-Psychoactive Cannabinoid Formulations for the Improvement of Sleep: A Double-Blinded, Randomized Controlled Trial”
Authors: J.L. Saleska et al.