UK Medical Cannabis Registry: Assessment of clinical outcomes in patients with insomnia

• Published in: Brain and behavior 2024-02, Vol.14 (2), p.e3410-n/a
• Main Authors: Vivek, Kavyesh, Karagozlu, Zekiye, Erridge, Simon, Holvey, Carl, Coomber, Ross, Rucker, James J., Weatherall, Mark W., Sodergren, Mikael H
• Format: Article
• Language: English
• Subjects: Benzodiazepines; Cannabidiol; Cannabis; cannabis‐based medicinal products; Clinical outcomes; Clinical significance; Comorbidity; Humans; Insomnia; Medical marijuana; Medical Marijuana - adverse effects; Melatonin; Nervous system; Patients; Pharmaceuticals; Quality of Life; Registries; Sleep; Sleep Initiation and Maintenance Disorders - drug therapy; sleep quality; Tetrahydrocannabinol; THC; United Kingdom
• ISSN: 2162-3279; 2162-3279
• DOI: 10.1002/brb3.3410

Introduction The primary aim of this study was to assess changes in sleep‐specific health‐related quality of life (HRQoL) for those prescribed cannabis‐based medicinal products (CBMPs) for insomnia. Methods A case series of UK patients with insomnia was analyzed. Primary outcomes were changes in the Single‐Item Sleep‐Quality Scale (SQS), Generalized Anxiety Disorder‐7 (GAD‐7), and EQ‐5D‐5L at up to 6 months from baseline. Statistical significance was identified as a p value < .050. Results 61 patients were included in the analysis. There was an improvement in the SQS from baseline at 1, 3, and 6 months (p < .001). There were also improvements in the EQ‐5D‐5L Index value and GAD‐7 at 1, 3, and 6 months (p < .050). There were 28 (45.9%) adverse events recorded by 8 patients (13.1%). There were no life‐threatening/disabling adverse events. Conclusion Patients with insomnia experienced an improvement in sleep quality following the initiation of CBMPs in this medium‐term analysis. Fewer than 15% of participants reported one or more adverse events. However, due to the limitations of the study design, further investigation is required before definitive conclusions can be drawn on the efficacy of CBMPs in treating insomnia. This observational study evaluates the outcomes of patients with insomnia enrolled on the UK Medical Cannabis Registry. Changes in sleep quality were observed at up to 6 months, with 13.1% of patients reporting an adverse event.