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Insomnia patients report better sleep when taking cannabis-based medical products
Patients reported better sleep as well as decreased anxiety and pain over 18 months of treatment
Insomnia patients taking cannabis-based medical products reported better quality sleep after up to 18 months of treatment, according to a study published August 27 in the open-access journal PLOS Mental Health by Arushika Aggarwal from Imperial College London, U.K., and colleagues.
About one out of every three people has some trouble getting a good night’s rest, and 10 percent of adults meet the criteria for an insomnia disorder. But current treatments can be difficult to obtain, and the drugs approved for insomnia run the risk of dependence. To understand how cannabis-based medical products might affect insomnia symptoms, the authors of this study analyzed a set of 124 insomnia patients taking medical cannabis products. They examined the patient’s reports of their sleep quality, anxiety/depression, and quality of life changes between one and 18 months of treatment.
The patients reported improved sleep quality that lasted over the 18 months of treatment. They also showed significant improvements in anxiety/depression as well as reporting less pain. About nine percent of the patients reported adverse effects such as fatigue, insomnia, or dry mouth, but none of the side effects were life-threatening. While randomized controlled trials will be needed to prove that the products are safe and effective, the authors suggest that cannabis-based medical products could improve sleep quality in insomnia patients.
Co-author Dr. Simon Erridge, Research Director at Curaleaf Clinic, summarizes: “Over an 18-month period, our study showed that treatment for insomnia with cannabis-based medicinal products was associated with sustained improvements in subjective sleep quality and anxiety symptoms. These findings support the potential role of medical cannabis as a medical option where conventional treatments have proven ineffective, though further randomised trials are needed to confirm long-term efficacy.”
He adds: “Conducting this long-term study provided valuable real-world evidence on patient outcomes that go beyond what we typically see in short-term trials. It was particularly interesting to observe signs of potential tolerance over time, which highlights the importance of continued monitoring and individualised treatment plans.”
Expert Reaction
These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.
Dr Jack Wilson is a Postdoctoral Researcher at The Matilda Centre for Research in Mental Health and Substance Use at The University of Sydney
These findings by Aggarwal and colleagues provide some encouraging signs that cannabis-based medicines may help people with insomnia, a condition for which there are very few effective treatments. However, because of this study’s limitations, it is important that we do not get ahead of ourselves. As the authors highlight, this observational study did not involve a comparison or ‘control group’, and the results relied on participants’ own reports, which can sometimes be biased.
Fortunately, we can look to several higher quality studies, called randomised-controlled trials (RCTs). These RCTs found that cannabis-based medicines increased sleep time compared to placebo among those with insomnia. Although, the same studies also found that there was no convincing evidence that cannabis improved general insomnia symptoms or sleep quality.
In Aggarwal’s study, around 1 in 10 participants reported an adverse event, but RCTs have recorded higher numbers, and at greater odds compared to those in the placebo group.
In the context of this study, and the wider literature, it is too soon to be convinced of cannabis as an effective treatment for insomnia. As the authors mention, there is a critical need for more high-quality studies that utilise representative samples.
Professor Anthony Hannan is Group Head of the Epigenetics and Neural Plasticity Group at the Florey Institute of Neuroscience and Mental Health
This new study reports a case series from these investigators, many of whom are associated with the Curaleaf Clinic, a private medicinal cannabis clinic (which the authors appropriately declare in the ‘Competing Interests’ section of the research article). It should be noted that treatment of conditions like insomnia are prone to placebo effects, which may have influenced the 124 participants (two thirds male) who had been using a range of cannabis-based medicinal products. This was a ‘case series’ which included a wide range of exposures, and variable doses, of cannabis-based products.
In order to provide a higher level of evidence, to follow up this study, a rigorous placebo-controlled clinical trial is required. Considering that cannabis appears to contain one or more molecules with medicinal potential, various companies are attempting to develop specific drugs targeting individual molecules, which will ultimately be tested in future placebo-controlled clinical trials (with both participants and researchers ‘blinded’ to treatment condition).
It should be noted that cannabis-based products are not without risks, and recreational cannabis use has been associated with increased risk of schizophrenia and other psychoses. Furthermore, there are various other treatments (both drug and non-drug/psychological/lifetyle approaches) used for insomnia, so anyone experiencing this increasingly common and debilitating condition should seek expert medical advice from a GP or other trained clinician.
Professor Mark Connor is from the Faculty of Medicine and Health Sciences at Macquarie University
Cannabis-based medicines have been investigated to reduce insomnia because of their history of community use for this indication and the possibility that they will alleviate some of the drivers of sleeplessness such as anxiety and pain. Pain, anxiety and disordered sleep are the main reasons why Australians use medical cannabis products. There have been a number of clinical trials of Cannabis products for insomnia in people, which have yielded uncertain but promising outcomes.
This study reports on a modest number of medicinal cannabis patients (124) drawn from a large patient registry associated with a private Cannabis clinic. Patients had been prescribed Cannabis products for insomnia, and had to have completed at least 18 months treatment.
The results show that there was a significant improvement in measures of sleep quality, anxiety and pain in the cohort after 1 month, which persisted to an extent for 18 months. Adverse events in these patients were rare and not serious. Interestingly, the doses of both cannabinoids prescribed – the psychoactive delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) increased by 6 fold and 10 fold respectively over the course of the 18 months the patients took them. Patients were taking much higher doses of THC than CBD.
The strengths of the study are that the patients were clinically diagnosed with insomnia, and their responses were followed for 18 months. There appeared to some benefit in this cohort to using Cannabis to improve sleep.
The major weakness of the study is that the patients included were highly likely to be responders – they continued to consume Cannabis products for 18 months after they were prescribed for insomnia, presumably because they felt that they were helping them sleep, or relieving another condition such as pain or anxiety. People who were prescribed Cannabis products for insomnia but stopped using them any time before 18 months were not included in the analysis.
This study provides more “real world” evidence that Cannabis products can safely help some people sleep better, but it does not help us understand what proportion of people with insomnia could be helped by Cannabis products. We don’t know how many people started consuming Cannabis products for insomnia but stopped, and whether they stopped because the drugs did not work or the adverse effects were not tolerable. While it is not realistic for a placebo comparison to be used in a retrospective study like this, the authors could have presented data on everyone who started on cannabis products after an insomnia diagnosis and compared outcomes.
The significant increase in the dose of THC to 120 mg day after 18 months suggests that patients adapted to the continued presence of the cannabinoid agonist - this is not surprising, but potentially concerning should they need to or want to stop consuming the drug.
