Updated: Dec 29, 2022
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A June 2021 study entitled "Treating Insomnia Symptoms with Medicinal Cannabis: A Randomized, Crossover Trial of the Efficacy of a Cannabinoid Medicine Compared with Placebo" that was published in the journal Sleep evaluated "the safety and efficacy of two weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months)."
The design of the study was that of a "double-blind, randomized, placebo-controlled, crossover study conducted between May and December 2019 at The University of Western Australia's Centre for Sleep Science" involving 23 participants.
Insomnia, technically called chronic insomnia disorder, is characterized by "difficulty initiating or maintaining sleep at least three nights per week for at least three months."
The study reported that insomnia, technically called chronic insomnia disorder, is characterized by "difficulty initiating or maintaining sleep at least three nights per week for at least three months" and that it is present in six to 15 percent of the population. It reported that insomnia often results in "poor health outcomes and reduced productivity."
The researchers reported that conventional treatments for insomnia often feature adverse effects that include "dependence, abuse potential, tolerance, daytime sedation, psychomotor impairment manifesting as falls and cognitive impairment, and increased risk of head injury or fracture. Based on the shortcomings of mainstream pharmaceutical options for insomnia patients, "cannabinoids have emerged as a possible alternative therapy for patients with insomnia who are considering therapeutic options."
"This Phase 1b study demonstrated that nightly sublingual administration of a novel cannabinoid formulation for two weeks improved insomnia symptoms without significant adverse events in participants with chronic insomnia symptoms.
"When taking [the synthetic cannabinoid] ZTL-101, participants reported an improvement in the time taken to fall asleep, time spent asleep, and feelings of being more rested/refreshed on waking.
"This study has demonstrated that ZTL-101, a novel cannabinoid improves insomnia symptoms and sleep quality in individuals with chronic insomnia."
"These data suggest that for patients with sleep onset insomnia, dosing 2–4 hours before desired bedtime might be optimal, while those with sleep maintenance insomnia should dose one hour before desired bedtime.
"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."
View the original study.
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