Study register · detailRCT · Sleep Disorders · 2024
Cannabidiol for moderate–severe insomnia: a randomized controlled pilot trial of 150 mg of nightly dosing
Narayan et al.·Journal of Clinical Sleep MedicineImpact 2.7
MixedGRADEModerate24 citations
Samplen = 30 Pat.
Duration2 weeks double-blind phase plus…
ControlPlacebo sublingual
EndpointISI
Blindingeinfachblind
DesignRCT
Cannabinoidcbd
Max. dose150.0 mg
Routeoromukosal
”Key finding
CBD 150 mg was similar to placebo on most sleep measures, but showed greater wellbeing and better objective sleep efficiency after 2 weeks.
Summary
n=30 pilot RCT, CBD 150 mg sublingual (n=15) vs. placebo (n=15) in primary insomnia over 2 weeks. No significant difference in insomnia severity, SOL, SE or WASO (all p>0.05). CBD group showed higher wellbeing over the entire period (difference=2,60; SE=1,20; p<0.05) and better objective sleep efficiency after 2 weeks (difference=6,85%; SE=2,95; p<0.05). Conclusion: 150 mg CBD similar to placebo on most sleep outcomes, with superior psychological wellbeing.
P
PopulationAdults with primary insomnia (moderate to severe), n=30
I
InterventionCBD 150 mg sublingual, daily 60 min before bedtime, 2 weeks
C
ControlPlacebo sublingual
O
OutcomeNo significant differences in insomnia severity, subjective sleep latency, sleep efficiency or WASO (all p>.05); CBD group showed higher wellbeing (MD=2.60, SE=1.20, p<.05) and superior objective sleep efficiency after 2 weeks (MD=6.85, SE=2.95, p<.05)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Study Objectives: Low-dose cannabidiol (CBD) has become readily available in numerous countries; however, little consensus exists on its efficacy as a sleep aid. This trial explored the efficacy of 150 mg of CBD (n = 15) compared with placebo (n = 15) as a sleep aid in primary insomnia. CBD supplementation was hypothesized to decrease insomnia symptoms and improve aspects of psychological health, relative to placebo.
Methods: Using a randomized, placebo-controlled, parallel design featuring a single-blind placebo run-in week followed by a 2-week double-blind randomized dosing phase, participants consumed the assigned treatment sublingually 60 minutes before bed nightly. Wrist-actigraphy and sleep diaries measured daily sleep. Sleep quality, sleep effort, and well-being were measured weekly over 4 in-laboratory visits. Insomnia severity and trait anxiety were measured at screening and study conclusion.
Results: Insomnia severity, self-reported sleep-onset latency, sleep efficiency, and wake after sleep onset did not differ between treatments throughout the trial (all P > .05). Compared with placebo, the CBD group reported greater well-being scores throughout the trial (trial end mean difference = 2.60; standard error: 1.20), transient elevated behavior following wakefulness scores after 1 week of treatment (mean difference = 3.93; standard error: 1.53), and had superior objective sleep efficiency after 2 weeks of treatment (mean difference = 6.85; standard error: 2.95) (all P < .05). No other significant treatment effects were observed.
Conclusions: Nightly supplementation of 150 mg CBD was similar to placebo regarding most sleep outcomes while sustaining greater well-being, suggesting more prominent psychological effects. Additional controlled trials examining varying treatment periods and doses are crucial.
Clinical Trial Registration: Registry: Australian New Zealand Clinical Trials Registry; Name: Cannabidiol (CBD) treatment for insomnia;
Url: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000070932; Identifier: ACTRN12620000070932.
Citation: Narayan AJ, Downey LA, Rose S, Di Natale L, Hayley AC. Cannabidiol for moderate-severe insomnia: a randomized controlled pilot trial of 150 mg of nightly dosing. J Clin Sleep Med. 2024;20(5):753-763.