2021 | Australia | Randomized placebo-controlled crossover trial
Walsh JH et al. Sleep. 2021;44:zsab149.
Methods:
Twenty-four adults with chronic insomnia were randomized in a crossover trial of two weeks of nightly sublingual ZTL-101, a THC/CBD/CBN extract, and placebo. Twenty-three completed the protocol. Assessments included questionnaires, sleep diaries, actigraphy, and polysomnography.
Findings: The extract improved insomnia severity by about five points over placebo and increased actigraphy-estimated total sleep by roughly 33 minutes. Most reported adverse events occurred during active treatment and were mild.
Limitations: The sample and treatment periods were small. The findings concern a cannabinoid mixture and do not isolate CBD or CBN effects, demonstrate long-term benefit, or establish restoration of REM sleep.