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Summary Insomnia or difficulty falling and or staying asleep is experienced by up to 30% of the general population. This randomised crossover double‐blind placebo‐controlled 6‐week trial aimed to assess the tolerability and effectiveness of the Entoura‐10:15 medicinal cannabis oil on sleep in adults with insomnia. A total of 29 participants with self‐reported clinical insomnia completed the crossover trial. Participants were randomly allocated to receive placebo or active oil containing 10 mg/ml tetrahydrocannabinol (THC) and 15 mg/ml cannabidiol (CBD) over 2‐weeks titrated 0.2–1.5 ml/day, followed by a 1‐week wash‐out period before crossover. Tolerability was assessed by daily diary. Effectiveness was measured by saliva midnight melatonin levels, validated questionnaires, i.e., the Insomnia Severity Index, and the Fitbit activity/sleep wrist tracker. Entoura‐10:15 medicinal cannabis oil was generally well tolerated, and was effective in improving sleep, whereby 60% of participants no longer classified as clinical insomniacs at the end of the 2‐week intervention period. Midnight melatonin levels significantly improved in the active group by 30% compared to a 20% decline in the placebo group ( p = 0.035). Medicinal cannabis oil improved both time and quality of sleep, in particular light sleep increased by 21 min/night compared to placebo ( p = 0.041). The quality of sleep improved overall by up to 80% in the active group ( p Phase2 = 0.003), including higher daily functioning ( p = 0.032). Observed effects were more pronounced in Phase 2 due to the period effect and loss of blinding. Entoura‐10:15 medicinal cannabis oil was well tolerated and effective in improving sleep in adults with insomnia.
Ried et al. (Tue,) studied this question.