Clinical Trial: Short-Term Use of Cannabinoids Effective in Patients with Chronic Insomnia

Crawley, Australia: The short-term use of plant-derived cannabis extracts is safe and effective in patients with chronic insomnia, according to placebo-controlled data published in the journal Sleep

Australian researchers assessed the use of a proprietary, sublingual cannabis extract product (ZTL-101, produced by the Australian-based company Zerila Therapeutics) versus placebo in 23 subjects with chronic insomnia. Extracts contained percentages of plant-derived THC, CBD, and CBN (cannabinol), as well as various terpenes. Subjects administered between 0.5ml and 1ml of ZTL-101 one hour prior to bedtime for a period of two weeks. 

Compared to placebo, cannabis extracts were associated with “significantly lower” Insomnia Severity Index scores. Participants receiving the extracts reported that they fell asleep faster, slept longer, and experienced improved sleep quality. No serious adverse events were reported.

Authors concluded: “This study has demonstrated that ZTL-101, a novel cannabinoid therapy, is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms. These improvements, observed over a two-week dosing period, are encouraging and support further investigation of ZTL-101 for the treatment of insomnia in studies with larger sample sizes.”

Data published in 2018 reported that the nighttime inhalation of herbal cannabis was associated with “clinically significant improvements” in patients with insomnia.

Findings of a more recent clinical trial, published last year in the journal BMJ Supportive & Palliative Care, reported that the use of herbal cannabis use is associated with an overall “positive effect on maintaining sleep throughout the night” in older subjects. Authors of the study concluded: “MC [medical cannabis] patients were less likely to report problems with staying asleep compared with non-MC patients. … These findings may have large public health impacts considering the aging of the population, the relatively high prevalence of sleep problems in this population along with increasing use of MC.”

Full text of the study, “Treating insomnia symptoms with medicinal cannabis: A randomized, cross-over trial of the efficacy of a cannabinoid medicine compared with placebo,” appears in Sleep.