Update Jun 2023:  The Cannabis Sleep Trial 1: ‘Medicinal Cannabis improves Sleep in Adults with Insomnia’ has now been published


In this randomised placebo-controlled cross-over 6-week trial participants used the Entoura 10:15 (THC:CBD) Medicinal Cannabis Oil.


Poster: Medicinal Cannabis improves Sleep in Adults with Insomnia – The Cannabis Sleep Study 1


doi: 10.1111/jsr.13793. Epub 2022 Dec 20.

Medicinal cannabis improves sleep in adults with insomnia: a randomised double-blind placebo-controlled crossover study


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 (pPhase2 = 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.


Update June 2023: The Cannabis Sleep Study 2 (The CANN Sleep Study) has now been closed

A randomised placebo-controlled 3-month clinical trial of medicinal cannabis for sleep disturbances in a healthy population.

NIIM was part of the trial conducted at four sites in Australia, located in Lismore, Brisbane, Sydney and Melbourne.

This trial tested a CBD only product in more than 400 participants.

Results to be published soon.