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To ensure the adequacy of the matching procedure, one participant of each pair had his treatment blindly chosen between the two treatment options available and the other participant matched to the first one was assigned to the remaining option.
Schematic representation of the participants selection and of the protocol — this was a four period crossover study. The exclusion criteria for the trial were: Thus, the volunteers were all non-smokers and had not taken any medications for at least 3 months before the study. Moreover, none of them had used marijuana more than five times in their lives no use in the last year and none had ever used any other illegal drug.
The following instruments were used: The apparatus used for the polysomnography exams consisted of different devices including electroencephalogram with the international 10—20 system to rule out the occurrence of epileptic seizures , electrooculogram, electromyogram of chin muscles and upper and lower limbs, nasal pressure cannula, oral thermistor, thoracic and abdominal respiratory inductive plethysmography straps, pulse oximetry, electrocardiogram, and snoring and body position sensors.
Video and sound were also recorded during the exam. Sleep stages were recorded in periods of 30 s, according to the criteria established by Rechtschaffen and Kales The following polysomnographic parameters were evaluated: Cannabidiol mg , The same amount of corn oil was used as placebo. The drug and placebo were packed in identical gelatin capsules. The mg dose was chosen based on previous studies that detected the acute anxiolytic effect of this dose Zuardi et al.
The time of drug delivery was based on previous studies that showed that the peak plasma concentration of an oral dose of CBD normally occurs 1—2 h after ingestion Agurell et al. Subjects were instructed to abstain from alcohol for 24 h and caffeine for at least 24 h before each visit to the laboratory. Subjects who reported having less than 6 h of sleep the previous night were excluded from the trial. After at least 8 h of fasting, subjects were instructed to have a light, standardized meal 2 h before the experiment.
For the present study, a randomized, double blind, and crossover model was used. Once one volunteer gave up participating the study, the 26 participants were assessed on two different occasions, in a 2-week interval, with identical procedures except for the substance that was administered.
In each visit, participants were first submitted to a cognitive and subjective evaluation, then an oral dose of CBD mg or placebo was administered 30 min before the polysomnographic recordings began. Polysomnography recordings were performed over 8 h.
The Kolmogorov-Smirnov test was used to check for normality. Non-parametric Wilcoxon or Friedman tests analyzed results that failed this test. A preliminary analysis indicated no gender effect; thus, the factors analyzed were drug, order of drug administration placebo-CBD versus CBD-placebo , and the interaction between drug and phase. A three-way repeated-measures ANOVA was employed to analyze data throughout the three phases of each exam.
In cases where sphericity conditions were not reached, the degrees of freedom of the repeated factor were corrected with the Huynh-Feldt epsilon. The results are presented according to the seven components assessed in the PSQI. The data obtained in the seven components and the total PSQI score are indicative of good sleep quality.
Total PSQI scores greater than five suggest difficulties in at least two components or moderate difficulties in more than three components Buysse et al.
The comparative analyses between CBD and placebo indicate that none of the parameters evaluated presented statistically significant changes. To check if this interaction could have potentially interfered with the results, we split the subjects, comparing the placebo and CBD groups separately in the two orders first placebo or CBD.
Again, there was no difference between groups in the two situations. We found no significant differences in polysomnography results following the administration of CBD and placebo to healthy volunteers. Likewise, there were no statistically significant changes in the subjective and cognitive measures collected during the two nights of polysomnographic exams.
Several parameters were recorded during polysomnography, considering that the essential tests for sleep staging are electroencephalogram, electrooculogram, and electromyogram. Given the lack of studies on the effect of CBD on human polysomnography-monitored sleep, other parameters were selected based on studies that tested the effect of other drugs in healthy volunteers Orr et al.
When comparing our polysomnographic data with results from other studies that used placebo in healthy volunteers, similar findings were observed Buysse et al. No statistically significant changes were found between the three different time points in the four factors evaluated by the VAMS and, as well as in the STAI. These results suggest that none of the different moments of the exams were subjectively rated as anxiogenic, sedative, uncomfortable or as producing cognitive impairment.
It should be noted here that, unlike other medications, the anxiolytic effect of CBD is only observed when given to subjects in obviously anxiogenic situations Zuardi et al. In the present study, we found no residual effects of CBD on cognitive or psychomotor functions compared to placebo, as measured by the Digit Symbol Substitution and Symbol Copying subscales of the WAIS, which have been described as sensitive measures of residual drug effects Garber et al.
Although no previous study on sleep and CBD applied these specific measures, our findings are consistent with a study on multiple sclerosis that used the digits test to assess possible changes in disease status following the administration of CBD associated with THC, in which no significant change was recorded Vaney et al.
It is known that lack of sleep can interfere with certain aspects of cognitive functioning, such as attentional levels Goel et al. However, the results of the present study did not show any significant impairment in either the reaction time or number of errors measured by the PVT, suggesting that the attention levels of the volunteers were preserved in the morning after the sleep assessment, regardless of the administration of CBD or placebo.
Not having administered the PVT test before CBD and placebo administration does not significantly affect the conclusions once the study does not intend to assess the effect of CBD on baseline vigilance which would require comparison with baseline PVT results , but to rather evaluate if CBD may be safely administered to patients without affecting their vigilance state overall, such that the patients may safely conduct every-day tasks, like for example driving.
Earlier preclinical studies have suggested that the therapeutic effects of CBD might depend on the presence of specific clinical conditions. As an example, Campos et al. Thus, the absence of changes in the sleep of healthy volunteers treated with CDB in our study should not be considered as a final indication that CBD could not have positive effects in patients with sleep disorders.
It is known that a major problem of several medications used in the treatment of clinical anxiety and depression is their effect on sleep architecture. Long-term use of benzodiazepines may also cause reduction of SWS, loss of efficacy in the treatment of insomnia, alterations in electroencephalogram results during sleep Poyares et al.
Likewise, selective serotonin reuptake inhibitors SSRIs and selective serotonin and norepinephrine reuptake inhibitors SNRIs may interfere with sleep architecture and decrease restorative sleep, leading to increased awakenings, reduced REM sleep, increased REM latency, as well as increased periodic limb movement during sleep Feige et al. Additionally, studies on the anxiolytic, antipsychotic and antiparkinson effects of CBD described no sedation or drowsiness side effects in their volunteers Zuardi et al.
These findings complement the literature on the few significant side effects resulting from the administration of CBD to humans in a wide range of doses, administered chronically or acutely Bergamaschi et al.
It seems, therefore, that CBD has an adequate safety profile with good tolerability and does not affect psychomotricity or cognition Hayakawa et al. The relative representativeness of the small sample size and the use of a single dose of CBD can perhaps be regarded as a limitation of our study, as it does not allow the assessment of the effects of chronic treatment with CBD on sleep. In the study by Chagas et al. Since the effects of CBD are biphasic Zuardi et al.
Moreover, monitoring changes in sleep using a conventional polysomnography presents some intrinsic limitations, as it is insufficient alone to detect drug-induced changes of the sleep EEG. For this purpose, a spectral analysis or a similar procedure is also needed. Conversely, the use of preclinical polysomnography to characterize drug-induced sleep disturbances has been increasingly recommended in the regulatory context Authier et al.
Finally, it is essential to evaluate the effects of CBD in a larger sample and in individuals diagnosed with sleep disorders in addition to healthy volunteers. Despite these limitations, this is the first controlled study to evaluate the effects of CBD on sleep architecture using polysomnography. Although the absence of interference with the sleep cycle is not sufficient for concluding that sleep is not affected, the results obtained contribute for the understanding of the effects of CBD in the modulation of sleep in humans.
We found no differences between CBD and placebo in respect to polysomnographic findings or cognitive and subjective measures in a sample of healthy subjects. Unlike widely used anxiolytic and antidepressant drugs such as benzodiazepines and SSRIs, the acute administration of an anxiolytic dose of CBD does not appear to interfere with the sleep cycle of healthy volunteers. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as evaluate the chronic effects of CBD in larger samples of patients with sleep and neuropsychiatric disorders.
The other authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. National Center for Biotechnology Information , U. Journal List Front Pharmacol v. Published online Apr 5. Guimaraes , 3 Alan Eckeli , 1, 2 Ana C. Crippa , 4 Antonio W. Zuardi , 1, 2 Jose D. Souza , 1, 2 Jaime E. Author information Article notes Copyright and License information Disclaimer. This article was submitted to Translational Pharmacology, a section of the journal Frontiers in Pharmacology.
Received Nov 6; Accepted Mar The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Abstract Cannabidiol CBD is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders.
Introduction Cannabidiol CBD , one of the major compounds of Cannabis sativa , has been shown to have several therapeutic effects including antipsychotic Zuardi et al. Open in a separate window. Instruments The following instruments were used: Polysomnography The apparatus used for the polysomnography exams consisted of different devices including electroencephalogram with the international 10—20 system to rule out the occurrence of epileptic seizures , electrooculogram, electromyogram of chin muscles and upper and lower limbs, nasal pressure cannula, oral thermistor, thoracic and abdominal respiratory inductive plethysmography straps, pulse oximetry, electrocardiogram, and snoring and body position sensors.
Here's what went down: One serving—about half a dropper—contains 5mg. I did feel sleepy about 45 minutes after taking it the last time I checked my phone but I'm pretty sure I was still awake a while longer.
I did sleep soundly, with some groggy effects when I woke up. The next two nights, I doubled my dosage to 10mg but I didn't fall asleep any faster. And right around 45 minutes, I felt my whole body downshift into a lower stress gear. It was actually so obvious that I stopped reading and thought, "Huh, I must be relaxed now! One tablespoon contains 15mg of CBD plus 2mg of melatonin, and the cherry flavor tasted like Nyquil, which I kind of liked.
Again, I could feel the effects of the CBD working through my system after about 40 minutes or so, but I didn't think I actually fell completely asleep any early than the other nights.
But I actually liked this product the least. I know they didn't contain actual marijuana, but it sure tasted like they did, and I hated having that lingering in my mouth even after brushing my teeth. It did not do that.
And while it didn't seem to have any wild effects on how long it took me to get to sleep, the quality of my pre-sleep bedtime was way more relaxed than that of the week before, when I would lie awake thinking about deadlines, to-dos, and the way I really wish I had responded to that text. Did I mention I'm Type A? And it'll involve a fair amount of trial and error to figure out what dosage is right for you.
Maybe if I had stuck with one type of CBD for the whole two weeks, my body would have become more adjusted to it and I would have noticed more dramatic effects. While it was certainly relaxing most nights , it wasn't a miracle sleep aid.
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