Treating insomnia symptoms with medicinal cannabis: a randomized, crossover trial of the efficacy of a cannabinoid medicine compared with placebo
Study objectives: This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).
Methods: Co-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
Results: Twenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (-5.07 units [95% CI: -7.28 to -2.86]; p = 0.0001) and self-reported SOL (-8.45 min [95% CI: -16.33 to -0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2 min [95% CI: -16.2 to -4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
Conclusions: Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.
Clinical trial: ANZCTR; anzctr.org.au; ACTRN12618000078257.
Keywords: cannabinoids; chronic insomnia; pharmacokinetics.
© Sleep Research Society 2021. Published by Oxford University Press on behalf of the Sleep Research Society.
Recent cannabis use linked to extremes of nightly sleep duration
Recent cannabis use is linked to extremes of nightly sleep duration–less than 6 hours or more than 9 hours–reveals a study of a large representative sample of US adults, published online in the journal Regional Anesthesia & Pain Medicine.
This pattern was even more pronounced among heavy users–those using on 20 out of the previous 30 days, the findings show.
Cannabis use in North America continues to increase, with around 45 million adults in the USA reporting this in 2019, which is double the figure reported in the early 2000s.
This change has partly been driven by widespread decriminalisation in many states over the past decade, as well as research suggesting that cannabinoids may have therapeutic value for pain relief and possibly anxiety and sleep disorders as well, say the researchers.
Cannabis has become popular as a sleep aid, particularly as the prevalence of sleep deprivation and insomnia has increased. Only two thirds of Americans get the recommended 7-9 hours of sleep every night, and almost half report daytime sleepiness every day.
But the evidence to date on the impact of cannabis on the sleep-wake cycle has been equivocal.
The researchers wanted to see if cannabis use might be linked to nightly sleep duration in a nationally representative sample of US adults (aged 20-59) who had taken part in the biennial National Health and Nutrition Examination Survey (NHANES) for the years 2005 to 2018 inclusive.
And they wanted to know if respondents reported difficulty falling asleep, staying asleep, or slept too much in the preceding 2 weeks; whether they had ever consulted a doctor about a sleep problem; and whether they regularly experienced daytime sleepiness on at least 5 of the preceding 30 days.
Survey respondents were characterised as recent or non-users if they had or hadn’t used cannabis in the past 30 days. Sleep duration was defined as short (less than 6 hours), optimal (6–9 hours), and long (more than 9 hours).
Information was gathered on potentially influential factors: age; race; educational attainment; weekly working hours; a history of high blood pressure, diabetes, and coronary artery disease; weight (BMI); smoking; heavy alcohol use (4 or more drinks daily); and prescriptions for opioids, benzodiazepines, ‘Z drugs’ (approved for insomnia), barbiturates, other sedatives, and stimulants.
Some 25,348 people responded to the surveys between 2005 and 2018, but the final analysis is based on 21,729 who answered all the questions, representing an estimated 146.5 million US adults.
The average nightly sleep duration was just short of 7 hours across the entire sample. Some 12% reported less than 6 hours, while 4% reported more than 9 hours a night.
A total of 3132 (14.5%) respondents said they had used cannabis in the preceding 30 days. Recent users were more likely to report not sleeping enough or sleeping too much.
They were 34% more likely to report short sleep and 56% more likely to report long sleep than those who hadn’t used cannabis in the preceding 30 days, after accounting for potentially influential factors.
And they were also 31% more likely to report difficulty falling asleep, staying asleep, or sleeping too much in the preceding 2 weeks, and 29% more likely to have discussed a sleeping problem with a doctor. But recent cannabis use wasn’t associated with frequent daytime sleepiness.
Further analysis of the frequency of cannabis use revealed that moderate users, defined as using on fewer than 20 out of the past 30 days, were 47% more likely to sleep 9 or more hours a night compared with non-users.
Heavy users, defined as using on 20 or more out of the preceding 30 days, were 64% more likely to experience short sleep and 76% more likely to experience long sleep compared with non-users.
These findings differed little across the survey years.
This is an observational study, and as such, can’t establish cause, or reverse causality, for that matter.
The researchers also point to several study limitations, including the reliance on self-reported data and the lack of information on cannabis dose. The historical and the historical and ongoing stigma associated with cannabis use may also have affected the responses to questions about cannabis use, they suggest.
But they say: “Increasing prevalence of both cannabis use and sleep deprivation in the population is a potential cause for concern.
“Despite the current literature demonstrating mixed effects of cannabis and various cannabinoid formulations on sleep architecture and quality, these agents are being increasingly used as both prescribed and unprescribed experimental therapies for sleep disturbances.”
They add: “Our findings highlight the need to further characterize the sleep health of regular cannabis users in the population. Sleep-wake physiology and regulation is complex and research about related endocannabinoid pathways is in its early stages.”
Notes for editors
Research: Recent cannabis use and nightly sleep duration in adults: a population analysis of the NHANES from 2005 to 2018 doi:10.1136/rapm-2021-103161I
Infographic: Recent cannabis use and nightly sleep duration in adults doi: 10.1136/rapm-2021-103294.pdf
Journal: Regional Anesthesia & Pain Medicine
Funding: None declared
Link to AMS press release labelling system
Externally peer reviewed? Yes
Evidence type: Observational; survey data
Sweet dreams: Using CBD oil for better sleep
At night, we sleep. It seems like the most obvious statement in the world, and yet it’s not as simple as when night falls, each of us falls into bed, ready to sleep – in one fell swoop – eight hours or more.
No, the truth is much crueler. Many of us suffer from falling asleep. For many of us, the bedtime routine involves hours of lying still, eyes closed, waiting for sleep to come out of nowhere. We end up getting fed up with this, and we start doing something else like surfing the internet or playing a video game, which doesn’t help us fall asleep either. The solution can be found in an online cbd store like ours.
Studies show that more than half of the population has difficulty falling asleep and about 25% of all of us sleep less than eight hours a night, which is the recommended amount.
CBD, thanks to its relaxing properties, is a great help for all those people who find it difficult to fall asleep.
It also helps you sleep better. Relaxing the muscles prevents many of the things that affect the quality of our sleep, such as muscle tension (avoiding bruxism, among others) and pains that could interrupt our precious sleep.
TO FALL ASLEEP:
There are two ways to use CBD oil for sleep so that, once our bedtime comes, we are closer to falling asleep much faster and easier than we usually do.
The simplest way is to take CBD oil at night. This dose should be quite high compared to a normal dose (five or six drops) and should be administered two to three hours before falling asleep. The idea is to establish a routine of starting sleep preparations at least one hour before bedtime. We take our CBD, and then we can get ready to shower, put on our pajamas, etc.
While all of this is going on, the CBD will take effect and by the time we are in bed we are very relaxed and ready for sleep.
The other way is to take CBD throughout the day in increments. Instead of relying on a sudden hit of relaxation, this method concentrates on building up this relaxation over the course of the day. We start with one to two drops in the morning, three to four drops at noon, and finally two to three drops one to half an hour before bedtime.
In this way our body arrives already relaxed at night and all it needs is a little push to be ready for rest.
TO SLEEP BETTER
The way CBD helps us to sleep better is the same: It relaxes our body and, thus, we adopt a better disposition to rest and relax.
For those who don’t have so much trouble falling asleep but have trouble sleeping well and without interruptions, it is best to administer CBD oil immediately before going to sleep. This means that we should have our bottle of CBD oil on our bedside table. Once we’ve gone to bed, are snuggled up and have seen all the new posts on social media, that’s the right time for CBD oil.
Having our CBD oil near our bed is important for people who are unable to sleep through the night. The moment you wake up and feel like you are going to be unable to fall back to sleep, take a small dose of CBD to remedy this and be able to fall back to sleep.
Napping is also important. For those of us who need a nap after lunch, it is important to administer a higher than usual dose before or during lunch. If your normal dose is two drops, for example, you are entitled to four drops before the nap. The nap is usually two to three hours, and the CBD effect lasts just over four hours.
Whichever way you look at it, CBD is extremely effective in treating a wide range of sleep disorders. As far back as a couple of decades ago, when CBD oil did not yet exist in the form it does today, marijuana was prescribed in many places to alleviate insomnia.
As a therapy, CBD oil is very successful, and is usually sufficient for most of those with mild problems, but if you need it, you can also accompany your CBD oil with other CBD-containing products. After all, this chemical compound is very safe to use and there is no risk of addiction or overdose.
Gaston is a Belgian writer born in 1975. He writes on various subjects, Health, Fashion, Technology, CBD and Art for various publications including Spirou. He is based in Brussels.