Cannabidiol for moderate-severe insomnia: a randomized controlled pilot trial of 150 mg of nightly dosing.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 38174873 · doi:10.5664/jcsm.10998
What was done
A randomized, double-blind, placebo-controlled parallel pilot trial evaluated sublingual cannabidiol (CBD, 150 mg nightly) compared with placebo taken 60 minutes before bed in 30 participants with primary insomnia (n = 15 CBD, n = 15 placebo). Following a 1-week single-blind placebo run-in, participants underwent a 2-week double-blind dosing phase. Sleep was monitored daily using wrist-actigraphy and sleep diaries. Sleep quality, sleep effort, and well-being were evaluated weekly across 4 laboratory visits, with insomnia severity and trait anxiety assessed at screening and study completion.
What was found
Insomnia severity, self-reported sleep-onset latency, sleep efficiency, and wake after sleep onset did not differ significantly between CBD and placebo (all P > .05). Compared with placebo, the CBD group showed significantly higher well-being scores at trial end (mean difference = 2.60, SE = 1.20, P < .05), higher behavior following wakefulness scores after 1 week (mean difference = 3.93, SE = 1.53, P < .05), and improved objective sleep efficiency measured by actigraphy after 2 weeks (mean difference = 6.85, SE = 2.95, P < .05). No other significant treatment effects were observed.
Why it matters
Nightly low-to-moderate dose CBD (150 mg) did not outperform placebo on subjective insomnia severity or most sleep parameters, though it showed modest positive associations with well-being and actigraphy-measured sleep efficiency.
Limits
The pilot study had a very small sample size (n = 30 total), which increases the risk of type II errors for sleep outcomes and false positives from multiple testing. The active treatment duration was short (2 weeks), only a single dose level (150 mg) was evaluated, and long-term efficacy and safety were not assessed.
Cited by
- partial Low-dose CBD acts as a wake-promoting agent, whereas high-dose CBD promotes sleep consistency.