Sleep Disorders
Study register · detail RCT (cross-over, doppelblind) · Sleep Disorders · 2023

Medicinal cannabis improves sleep in adults with insomnia: a randomised double-blind placebo-controlled crossover study

Clear benefit GRADE Moderate 71 citations
Samplen = 29 Pat.
Duration6 weeks total study duration
ControlPlacebo oil
EndpointISI
Blindingdoppelblind
DesignRCT (cross-over, doppelblind)
Cannabinoidkombination
THC:CBD2:3
Max. dose37.5 mg
Routeoral
Key finding

Medicinal cannabis significantly improved sleep: 60% of participants were no longer clinical insomniacs after 2 weeks, melatonin increased by 30% (vs. a 20% decrease under placebo), light sleep increased by 21 min/night (p=0.041), sleep quality improved by up to 80% (p=0.003).

Summary

n=29 adults with clinical insomnia, randomized double-blind placebo-controlled crossover over 6 weeks (2 weeks active/placebo, 1 week wash-out). Entoura-10:15 oil (10 mg/ml THC + 15 mg/ml CBD, titrated 0,2–1,5 ml/day): 60% no longer met clinical insomnia criteria after 2 weeks; midnight melatonin +30% vs. −20% placebo (p=0,035); light sleep +21 min/night vs. placebo (p=0,041); sleep quality improvement up to 80% in phase 2 (p=0,003).

P
PopulationAdults with clinically self-reported insomnia, n=29
I
InterventionEntoura-10:15 medicinal cannabis oil (10 mg/ml THC + 15 mg/ml CBD), oral, 0,2–1,5 ml/day titrated, 2 weeks
C
ControlPlacebo oil (identical appearance)
O
OutcomeInsomnia Severity Index: 60% of participants no longer classified as clinical insomniacs; midnight melatonin +30% (active) vs. –20% (placebo), p=0,035; light sleep +21 min/night vs. placebo, p=0,041; sleep quality improved by up to 80% (phase 2, p=0,003)
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding Double-blind
Effect size Clear benefit
Citations / year
Authors
Ried K, Tamanna T, Matthews S et al.
DOI 10.1111/jsr.13793
Design: RCT (cross-over, doppelblind)
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