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Published (Version of Record)CC BY V4.0, Open Access
Journal article
Treating insomnia symptoms with medicinal cannabis: a randomized, crossover trial of the efficacy of a cannabinoid medicine compared with placebo
Sleep (New York, N.Y.), Vol.44(11)
2021
PMID: 34115851
Abstract
Study Objectives
This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).
Methods
Co-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
Results
Twenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (−5.07 units [95% CI: −7.28 to −2.86]; p = 0.0001) and self-reported SOL (−8.45 min [95% CI: −16.33 to −0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (−10.2 min [95% CI: −16.2 to −4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
Conclusions
Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.
Details
- Title
- Treating insomnia symptoms with medicinal cannabis: a randomized, crossover trial of the efficacy of a cannabinoid medicine compared with placebo
- Authors/Creators
- Jennifer H Walsh - The University of Western AustraliaKathleen J Maddison - The University of Western AustraliaTim Rankin - The University of Western AustraliaKevin Murray - The University of Western AustraliaNigel McArdle - Sir Charles Gairdner HospitalMelissa J Ree - The University of Western AustraliaDavid R Hillman - The University of Western AustraliaPeter R Eastwood - The University of Western Australia
- Publication Details
- Sleep (New York, N.Y.), Vol.44(11)
- Publisher
- Oxford University Press
- Identifiers
- 991005592656107891
- Copyright
- © Sleep Research Society 2021
- Murdoch Affiliation
- Vice Chancellery
- Language
- English
- Resource Type
- Journal article
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- Collaboration types
- Domestic collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.100 Substance Abuse
- 1.100.625 Cannabinoids
- Web Of Science research areas
- Clinical Neurology
- Neurosciences
- ESI research areas
- Neuroscience & Behavior