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

Summary & key facts

This small trial tested a medicinal cannabis oil in 29 adults who reported clinical insomnia. Each person took either the active oil (10 mg per ml THC and 15 mg per ml CBD) or a placebo for two weeks, had one week off, then switched to the other treatment. The oil was generally well tolerated and helped sleep: about 60% of people no longer met the study's insomnia threshold after two weeks on the active oil, midnight melatonin (a sleep-related hormone) rose with the oil while it fell with placebo, and light sleep increased by roughly 20 minutes per night. The results were stronger in the second treatment period, but the study was short, had few people, and some loss of blinding, so we can’t assume these effects last long-term or apply to everyone.

Key facts:

• Study setup: 29 adults with self-reported clinical insomnia took part. Each person used the active oil or a placebo for two weeks, then had one week without treatment, and then switched to the other treatment.
• Dose details: the active oil contained about 10 mg of THC per millilitre and 15 mg of CBD per millilitre. Participants’ doses were slowly adjusted to between about 0.2 and 1.5 ml per day.
• How sleep was measured: researchers used saliva tests for midnight melatonin (a hormone that helps control sleep), a standard insomnia questionnaire, and a Fitbit wrist tracker to measure sleep time and stages.
• Main sleep result: about 60% of people were no longer classed as clinical insomniacs after two weeks on the active oil.
• Melatonin result: midnight melatonin levels rose by about 30% with the active oil, while they fell by about 20% with placebo.
• Sleep-stage result: light sleep increased by about 21 minutes per night on the active oil compared with placebo.
• Self-reported effects: people reported bigger improvements in overall sleep quality—up to about an 80% improvement in some measures—and better daily functioning when on the active oil.
• Tolerability: the oil was generally well tolerated according to daily diaries.
• Limitations: the trial was short and small, and researchers reported a period effect and loss of blinding (people may have guessed when they were on the active oil), which could make the results less certain and harder to generalise.

Abstract

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.

Topics

Cannabis and Cannabinoid Research Sleep and related disorders Sleep and Wakefulness Research

Categories

Cognitive Neuroscience Life Sciences Neuroscience

Tags

Adverse effect Alternative medicine Anesthesia Bedtime Crossover study Environmental health Insomnia Internal medicine Medicine Pathology Placebo Population Psychiatry Randomized controlled trial Sleep onset Tolerability

Substances

medical cannabis

Conditions & symptoms

Sleep disorder Poor sleep