First clinical trial of cannabis for insomnia shows positive results

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An Australian-based research team finds good results in using cannabis to treat sleeplessness

Having a clinical trial approved to test the effects of medicinal cannabis for a specific ailment is an important step before presenting an official medicinal product to the public. The world’s first placebo-controlled clinical trial for cannabis effects on chronic insomnia is currently ongoing, and it is showing positive results in its initial phases. Through the use of a new cannabis-based medication, Australian researchers are finding positive results that are showing statistically significant improvements in sleep quality, which is also sensitive to dosage.

“This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia,” said Peter Eastwood, lead researcher on the project. “The fact that ZTL-101 treatment achieved statistically significant, dose-responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window.” This study began in 2018 with the design of the formulation that is now being tested. The medical cannabis company behind this new medication is Zelira Therapeutics, although the trials are being conducted by the University of Western Australia.

The trial was placebo-controlled and double-blind and recruited 23 subjects suffering from chronic insomnia. The method of administration is an oil that is used under the tongue, and the subjects could choose from a single or double dose, depending on the severity of their symptoms. “Positive patient experiences with minimal side-effects are critical to the success of any insomnia drug and highlights the potential for ZTL-101 to address a key area of unmet need,” Eastwood says. “It is likely that further improvements in efficacy could be achieved by dosing over a longer period and potentially at higher doses.”