Study register · detailRCT · Sleep Disorders · 2025
Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study.
Wang et al.·Journal of clinical sleep medicineImpact 2.7
MixedGRADEHigh12 citations
Samplen = 125 Pat.
Duration4 weeks
ControlPlacebo
EndpointSWS+REM sleep proportion
Blindingdoppelblind
DesignRCT
Cannabinoidcbd
Max. dose300.0 mg
Routeoral
”Key finding
Marginal increase in the combined proportion of deep sleep and REM sleep by 1,3% compared to placebo (p=0,03), with no effect on total sleep time, resting heart rate, or heart rate variability.
Summary
n=125 persons with insomnia, double-blind crossover RCT over 4 weeks. CBD 300 mg + terpenes (1 mg each of linalool, myrcene, phytol, limonene, α-terpinene, α-terpineol, α-pinene, β-caryophyllene) vs. placebo. Primary endpoint (SWS+REM sleep percentage): marginally significant increase of 1.3% (SE 0.60%, 95% CI 0.1–2.5%, p=0.03). Stronger effects in participants with low baseline SWS+REM (up to 48 min/night increase). No effects on total sleep time, resting heart rate, or HRV. No adverse events.
ControlPlacebo (oral, identical without active ingredient)
O
OutcomeCBD-terpenes marginally increased the SWS+REM sleep proportion by 1,3% vs. placebo (95% CI 0,1–2,5%; p=0,03); more pronounced effects in participants with low baseline SWS+REM proportion as well as in day sleepers (up to 48 min/night additional)
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeMixed
Citations / year★★★★★
Authors
Wang M, Faust M, Abbott S, Patel V, Chang E, Clark JI, Stella N, Muchowski PJ
Study Objectives: Cannabidiol (CBD) is increasingly used as a health supplement, though few clinical studies have demonstrated benefits. The primary objective of this study was to evaluate the effects of an oral CBD-terpene formulation on sleep physiology in individuals with insomnia.
Methods: In this double-blind, placebo-controlled, randomized clinical trial, 125 individuals with insomnia received an oral administration of CBD (300 mg) and terpenes (1 mg each of linalool, myrcene, phytol, limonene, alpha-terpinene, alpha-terpineol, alpha-pinene, and beta-caryophyllene) for >/= 4 days/wk over 4 weeks using a crossover design. The study medication was devoid of Delta(9)-tetrahydrocannabinol. The primary outcome measure was the percentage of time participants spent in the combination of slow-wave sleep (SWS) and rapid eye movement (REM) sleep stages, as measured by a wrist-worn sleep-tracking device.
Results: This CBD-terpene regimen marginally increased the mean nightly percentage of time participants spent in SWS + REM sleep compared to the placebo (mean [standard error], 1.3% [0.60%]; 95% confidence interval, 0.1-2.5%; P = .03). More robust increases were observed in participants with low baseline SWS + REM sleep, as well as in day sleepers. For select participants, the increase in SWS + REM sleep averaged as much as 48 minutes/night over a 4-week treatment period. This treatment had no effect on total sleep time, resting heart rate, or heart rate variability, and no adverse events were reported.
Conclusions: Select CBD-terpene ratios may increase SWS + REM sleep in some individuals with insomnia and may have the potential to provide a safe and efficacious alternative to over-the-counter sleep aids and commonly prescribed sleep medications.
Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia;
Url: https://clinicaltrials.gov/study/NCT05233761; Identifier: NCT05233761.
Citation: Wang M, Faust M, Abbott S, et al. Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study. J Clin Sleep Med. 2025;21(1):69-80.