Treating Insomnia Symptoms with Medicinal Cannabis: A Randomized, Cross-Over Trial of the Efficacy of a Cannabinoid Medicine Compared with Placebo

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Abstract

STUDY OBJECTIVES: This randomized, double-blind, placebo-controlled, cross-over study was conducted to evaluate the safety and efficacy of two-weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥three 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±9years) completed the protocol. No serious adverse events were reported. Forty mild, non-serious, 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 (-5.07units [95%CI: -7.28 to -2.86]; p=0.0001) and self-reported SOL (-8.45mins [95%CI: -16.33 to -0.57]; p=0.04) and increased self-reported TST (64.6mins [95%CI: 41.70 to 87.46]; p<.0001), sSQ, (0.74units [95%CI: 0.51 to 0.97]; p<0.0001) and feeling of being rested on waking (0.51units [95%CI: 0.24 to 0.78]; p=0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2mins [95%CI: -16.2 to -4.2]; p=0.002), and increased actigraphy-derived TST (33.4mins [95%CI: 23.07 to 43.76]; p<0.001) and SE (2.9% [95%CI: 2.0 to 3.8]; p=0.005).

CONCLUSION: 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.

Original languageEnglish
Article numberzsab149
JournalSleep
Volume44
Issue number11
Early online date11 Jun 2021
DOIs
Publication statusPublished - 1 Nov 2021

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