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
GemischtGRADEHoch12 Zitate
Stichproben = 125 Pat.
Dauer4 Wochen
KontrollePlacebo
EndpunktSWS+REM-Schlafanteil
Verblindungdoppelblind
DesignRCT
Cannabinoidcbd
Max. Dosis300.0 mg
Applikationoral
”Kernaussage
Marginale Erhöhung des kombinierten Anteils von Tiefschlaf und REM-Schlaf um 1,3% gegenüber Placebo (p=0,03), ohne Effekt auf Gesamtschlafzeit, Ruheherzfrequenz oder Herzratenvariabilität.
Zusammenfassung
n=125 Personen mit Insomnie, doppelblinde Cross-over-RCT über 4 Wochen. CBD 300 mg + Terpene (je 1 mg Linalool, Myrcen, Phytol, Limonen, α-Terpinen, α-Terpineol, α-Pinen, β-Caryophyllen) vs. Placebo. Primärer Endpunkt (SWS+REM-Schlaf-Prozentsatz): marginal signifikante Zunahme um 1.3% (SE 0.60%, 95% CI 0.1–2.5%, p=0.03). Stärkere Effekte bei Teilnehmenden mit niedrigem Baseline-SWS+REM (bis zu 48 min/Nacht Zunahme). Keine Effekte auf Gesamtschlafzeit, Ruhepuls oder HRV. Keine unerwünschten Ereignisse.
OutcomeCBD-Terpene erhöhte den SWS+REM-Schlafanteil marginal um 1,3% vs. Placebo (95%-KI 0,1–2,5%; p=0,03); ausgeprägtere Effekte bei Teilnehmern mit niedrigem Baseline-SWS+REM-Anteil sowie bei Tagschläfern (bis zu 48 min/Nacht zusätzlich)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
Qualitätsprofil
Größe★★★★★
VerblindungDoppelblind
EffektstärkeGemischt
Zitate / Jahr★★★★★
Autoren
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.