2nd August 2021
By Emily Ledger

Insomnia is a common chronic sleep condition in which sufferers have trouble getting to sleep and/or staying asleep. There are a number of conventional treatment options for insomnia and other sleep conditions, however, research and anecdotal evidence is increasingly suggesting that cannabis-based products may also be effective in some cases.

Estimations by the Mental Health Foundation suggest that only a third of people in the UK are classed as “good sleepers”. In addition, a further third may also have what is known as chronic insomnia. Sleep conditions, including insomnia, are often associated with disruption to personal and professional aspects of everyday life and are often linked to heightened levels of anxiety, stress, and depression.

Conventional treatment options for insomnia include lifestyle changes such as limiting your alcohol use, increased exercise, and going to bed at a set time, however, if these do not work then sleep aids such as melatonin or cognitive behavioural therapy may also be considered.

There is a growing body of anecdotal evidence that cannabis may be useful in treating sleep conditions, including insomnia. Medical cannabis products are also increasingly being considered as a treatment option for treatment-resistant chronic insomnia. A recent trial aimed to assess how a cannabinoid formulation can affect symptoms in patients with chronic insomnia disorder.

Design and Methods of the Study

A sample of 24 participants aged between 25-70 years with self-reported chronic insomnia – defined as difficulty initiating sleep and/or maintaining sleep on three or more nights per week, for three months in addition to an Insomnia Severity Index (ISV) score of more than 10 – were recruited for the study.

A cannabinoid formulation containing THC, CBD, and CBN (ZTL-101) was used as the trial medication. Prior to medical cannabis treatment, the researchers established a two-week baseline period, during which participants wore a wrist-based activity monitor.

On the 14th night of the baseline period and both treatment arms of the study, a polysomnography (PSG) study was performed, and the results were aligned with AASM criteria (using for respiratory events). Studies were scored according to these criteria by a single experienced scorer who was blinded to treatment.

After being screened for potential reactions to the study medication (THC 3mg; CBN 0.3mg; CBD 0.15mg + 0.15ml placebo) followed by a one-week washout period, participants were randomly allocated to either ZTL-101 or placebo for two weeks. Participants were then put through another one-week washout period before being crossed over to the alternate study arm for a further two weeks.

In addition to measuring sleep quality and quantity through the use of self-reported sleep diaries, actigraphy, Insomnia Severity Index scores, and PSGs, the researchers also aimed to determine the frequency, type, and severity of adverse events throughout each arm of the study.

Results of the Study

Of the 24 participants who proceeded to dosing, 23 completed the protocol. Of these 23, 12 (52%) were taking a double dose of ZTL-101 on the 14th night of the active arm of the study, compared with 16 (69.5%) who were taking a double dose of placebo. One hundred per cent of the participants guessed that they were receiving active treatment when using ZTL-101 – 17 (81%) of these participants stated that the reason for their guess was “Improvement in sleep quality”.

Insomnia Symptoms

At the end of two weeks of ZTL-101 treatment, ISI scores were significantly lower than scores following the placebo arm of the study (an adjusted mean difference of -5.1). According to the self-reported sleep diaries, participants perceived that they went to sleep faster, slept for longer, had improved sleep quality, and felt more rested/refreshed on waking.

The novel cannabinoid formulation used in this study was well tolerated with only one participant withdrawal, due to a non-serious adverse event. At least one adverse event was experienced by 17 of the remaining 23 participants, with dry mouth and dizziness being the most frequently reported. This was comparable to other trials using medicinal cannabis formulations.

The mean total time spent asleep across the two-week active treatment period was over 7 hours – the minimum amount of sleep recommended for adults, and above average for individuals of comparable age without insomnia. However, the average time spent awake during the night remained high and the time taken to fall asleep was unchanged.

Conclusions

The researchers concluded that this study “demonstrated that ZTL-1010, a novel cannabinoid therapy, is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms”.

However, it is noted that further dedicated studies are needed to confirm the findings of this trial. Nonetheless, these results are encouraging and support further investigations on the potential of cannabinoids for the treatment of insomnia and other sleep conditions

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