Clinical Trial Finds Cannabis Oil is Well-Tolerated, Effective Insomnia Treatment

Insomnia is often listed among the qualifying conditions to obtain a medical cannabis card.
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Many will attest, alongside myriad additional studies, to the sedative, relaxing qualities of cannabis as a sleep aid. Now, a new study published in the Journal of Sleep Research adds additional insight surrounding the benefits of cannabis for treating insomnia, finding that the short-term use of plant-derived cannabis extracts is well-tolerated and effective for patients diagnosed with insomnia.

Insomnia involves difficulty falling or staying asleep and is relatively common, experienced by up to 30% of the general population. In their introduction, the authors point to the potential for cannabis to help alleviate sleep dysfunction along with the impact of individual cannabinoids on sleep. Specifically, they reference the sedative effect of THC and the potential of CBD as a sedative in higher doses.

The trial looked to assess the tolerability and effectiveness of medicinal cannabis oil on sleep in adults with insomnia. The study was conducted between May 2020 and May 2021 at the National Institute of Integrative Medicine in Melbourne, Australia. Researchers assessed the use of a cannabis oil product, versus placebo, in 29 subjects with chronic insomnia. 

Each extract contained 10mg of THC and 15mg of CBD per milliliter, along with a lesser amount of other cannabinoids and naturally occurring terpenes, and each participant consumed either the extract or a placebo for a two-week period. Participants were instructed to take the oil in the evening with food, increasing their doses by 0.1ml (1mg THC/1.5mg CBD) increments each day, starting with 0.2ml on the first day and maxing out at 1.5ml (15mg HC/22.5mg CBD).

The six-week study consisted of a one-week run-in period, a two-week intervention period, a one-week wash-out period and a second two-week intervention period, with four total assessments taken at the start and completion of each intervention phase. Primary outcome measures included saliva midnight melatonin levels and insomnia symptoms assessed by the ISI questionnaire.

Ultimately, investigators reported that participants using cannabis extracts experienced improved sleep quality by up to 80%, and 60% of participants were no longer classified as clinical insomniacs at the end of the two-week intervention period. Four of the total participants (14%) had no side effects, while 24 (83%) reported non-serious side effects, possibly related to the active medication, like dry mouth, diarrhea, nausea and vertigo. 

Researchers also noted that, aside from dry mouth, all side effects were only experienced on one or two non-consecutive days. About half of the participants in the active group reached the maximum dose over two weeks, though 20% stopped increasing their dose at 0.4-0.6ml due to side effects like vertigo or dizziness. Two participants reported more serious side effects, acute onset tachycardia (accelerated heart rate) and extreme dizziness, both of which were alleviated by lowering the dose.

At the conclusion of the trial, all but one participant (96%) found that cannabis oil was an acceptable treatment for insomnia, and the majority of participants (79%) requested an ongoing prescription for the medicinal cannabis oil, even the participant who had tachycardia. Five of the six participants who chose not to continue taking the cannabis oil cited reasons other than side effects (like work restrictions, driving a vehicle) for discontinuing treatment.

“Our short-term trial suggests Entoura 10:15 medicinal cannabis oil, containing THC:CBD 10:15 and lesser amounts of other [cannabinoids] and naturally occurring terpenes, to be well tolerated and effective in significantly improving sleep quality and duration, midnight melatonin levels, quality of life, and mood within 2-weeks in adults with insomnia,” researchers concluded. “Long-term studies are needed to assess whether chronic medicinal cannabis intake can restore natural circadian rhythm without the need for ongoing cannabis intake.”

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