Growing consumer interest in cannabidiol (CBD) products being utilised by those suffering from insomnia is supported by past studies concluding there can be benefits found in CBD contribution towards positive sleep patterns.
In a new study, the effect of Medicinal cannabis on adults with insomnia explored cannabidiol (CBD) isolate and tetrahydrocannabinol (THC) in combination. The objective of the research was to determine how well various CBD and melatonin combinations affected sleep, concluding that “Data implied that low-dose CBD use over time is safe and may enhance sleep quality.”
The authors note: “To our knowledge, our trial is the first to include midnight melatonin levels to assess the effect of medicinal cannabis oil on sleep quality in adults with insomnia, which provided a useful objective outcome measure to be included in any future trials assessing the effectiveness of medicinal cannabis on sleep.”
The study
In the randomised double-blind placebo-controlled crossover study, 29 participants were randomly allocated to receive placebo or Entoura 10:15 medicinal cannabis oil containing 10 mg/ml tetrahydrocannabinol (THC) and 15 mg/ml cannabidiol (CBD) over 2-weeks, followed by a 1-week wash-out period before crossover. Results were attained by saliva night time melatonin levels, validated questionnaires and Fitbit activity.
The resulting data suggests over the course of two weeks, the active group's insomnia symptoms decreased compared to the placebo group. The active group's total amount of sleep increased, averaging 30 minutes per night more than pre-study, compared to the placebo group's average increase of nine minutes per night. Midnight melatonin levels significantly improved in the active group by 30% compared to a 20% decline in the placebo group (p = 0.035).
The report concludes that medicinal cannabis oil improved both time and quality of sleep, in particular light sleep increased by 21 min/night compared to placebo (p = 0.041). The quality of sleep improved overall by up to 80% in the active group (pPhase2 = 0.003), including higher daily functioning (p = 0.032). Observed effects were more pronounced in Phase 2 due to the period effect and loss of blinding.
“79%–89% of the participants in the active or placebo groups reported moderate-to-severe clinical insomnia at baseline, while at the end of the trial, 65% of participants no longer classified as clinical insomniacs, which was clinically and statistically significant, ” the report concludes, adding, “We see this data as ‘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.”
While this was a combination study, the research team concluded that the effects of CBD isolate and formulations including CBD and Cannabinol (CBN), either alone or in combination with 5mg Cannabichromene, were not significantly different.
They note that long-term studies are needed to assess whether chronic medicinal cannabis intake can restore natural circadian rhythm without the need for ongoing cannabis intake.
Adverse Effects
The study did report that varying degrees of adverse effects were reported by a small percentage of participants, one of which was a case of acute onset tachycardia. This was resolved the following day by reducing intake from 1.4ml CBD to 0.4ml titration.
Commenting on the report, Dr. Mark Tallon, MD at Legal Food Ltd, said: “Whilst the cannabinoid market offers great promise the data on dosages and the specific cannabinoids (or mix of cannabinoids) are in their infancy. Go back 10 years and almost no physiologist even knew what the endocannabinoid system was never mind how to manipulate it to deliver positive health benefits.
“In Europe at least we have zero claims on CBD (although some claims on hemp) that have been approved under the EU health claims legislation. This means any claim used that suggest not only a health claims, but a nutrition claim (such as high in CBD) is illegal.
"There are, however, many non-commercial ways that the benefits of cannabinoids can be communicated and we are trying to help our clients achieve this based on their new studies until one makes the decision to submit for a health claim.
“We know from the Glucosamine case law in the UK if the consumer views a substances as a medicine and we have a registered medicine there are classification risks. My advice as you would expect is seek professional advice on how to discuss the benefits of CBD and how to limit the risk of providing a dose that may be injurious to health over the long term. The issue remains the FSA permit up to 70mg of CBD per day.
"However, there are two significant issues here: first, the FSA have data suggesting this does greatly exceeds the NOAEL (level of no adverse effects), as such should it be updating is guidance or is leaving this 70mg dose a consumer risk? Will the FSA be liable if they do not amend this dose range and someone becomes harmed?; Second, The 70mg was based on paper assessment of the available literature some years ago however this was on CBD and we know that ‘CBD products’ do not only contain CBD so what does this mean for safety?”
Further research is needed to progress safely with CBD products entering the mainstream market, adds Dr Tallon.
Dr Tallon shares: “I can tell you that there is now a significant raft of research - some to be published in the next quarter - covering pain, sleep and inflammation. How these benefits are communicated could make the difference between being a food or medicine and the clear position that European regulators don’t want this on the market could use this to make a general classification all CBD is medicinal.”
Background research
The authors note that the study's findings are in line with a systematic review of 41 studies looking at the effect of cannabis on sleep as a secondary outcome measure, whereby cannabis was found to improve sleep. The findings are also in agreement with a recent similar randomised crossover trial investigating the effect of cannabis (max dose: 20 mg THC + 2 mg cannabinol + 1 mg CBD/ml) on sleep as primary outcome measure, whereby medicinal cannabis oil was found to be effective in improving insomnia symptoms and sleep quality after a 2-week trial period in adults with chronic insomnia.
Journal: Journal of Sleep Research
https://doi.org/10.1111/jsr.13793
“Medicinal cannabis improves sleep in adults with insomnia: a randomised double-blind placebo-controlled crossover study”
Authors: Karin Ried, Tasnuva Tamanna, Sonja Matthews, and Avni Sali[NH9]