The Safety and Comparative Effectiveness of Non-Psychoactive Cannabinoid Formulations for the Improvement of Sleep: A Double-Blinded, Randomized Controlled Trial

Summary & key facts

Researchers gave about 1,800 adults with sleep problems one of six capsule products for four weeks. The capsules contained either 15 mg of CBD or 5 mg of melatonin, sometimes mixed with small amounts of other cannabis-related chemicals. Most people reported a clear improvement in sleep. Low-dose CBD appeared safe and helped sleep, but it did not work better than 5 mg melatonin, and adding the extra minor cannabinoids did not seem to add benefit.

Key facts:

• About 1,800 adults who said they had sleep disturbance took part. They were randomly put into six groups and took a 4-week supply of capsules.
• The capsules contained either 15 mg of CBD or 5 mg of melatonin. Some capsules also included small amounts of cannabinol (CBN) or cannabichromene (CBC).
• Sleep was measured over five weeks (one week before treatment and four weeks during treatment) using weekly online questionnaires that ask about sleep disturbance.
• Between about 56% and 75% of people across the different products had a clinically important improvement in sleep quality.
• There were no clear differences in sleep improvement between 15 mg CBD alone and the versions that added CBN or CBC.
• There were also no clear differences in sleep improvement between 15 mg CBD alone and 5 mg melatonin, whether melatonin was used alone or combined with the minor cannabinoids.
• The study reported that using a low dose of CBD for this period appeared safe, but its effects did not exceed those of 5 mg melatonin.

Abstract

BACKGROUND: Clinical evidence on the use of cannabidiol (CBD) for sleep remains limited. Even fewer studies have tested the comparative effectiveness of cannabinoid formulations found within CBD products used for sleep or how they compare to other complementary therapies such as melatonin. METHODS: Participants (N = 1,793 adults experiencing symptoms of sleep disturbance) were randomly assigned to receive a 4-week supply of 1 of 6 products (all capsules) containing either 15 mg CBD or 5 mg melatonin, alone or in combination with minor cannabinoids. Sleep disturbance was assessed over a period of 5 weeks (baseline week and 4 weeks of product use) using Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8A, administered via weekly online surveys. A linear mixed-effects regression model was used to assess the differences in the change in sleep disturbance through time between each active product arm and CBD isolate. RESULTS: < 0.001 in within-group comparisons). Most participants (56% to 75%) across all formulations experienced a clinically important improvement in their sleep quality. There were no significant differences in effect, however, between 15 mg CBD isolate and formulations containing 15 mg CBD and 15 mg cannabinol (CBN), alone or in combination with 5 mg cannabichromene (CBC). There were also no significant differences in effect between 15 mg CBD isolate and formulations containing 5 mg melatonin, alone or in combination with 15 mg CBD and 15 mg CBN. CONCLUSIONS: Our findings suggest that chronic use of a low dose of CBD is safe and could improve sleep quality, though these effects do not exceed that of 5 mg melatonin. Moreover, the addition of low doses of CBN and CBC may not improve the effect of formulations containing CBD or melatonin isolate.

Topics

Cannabis and Cannabinoid Research Forensic Toxicology and Drug Analysis Psychedelics and Drug Studies

Categories

Health Sciences Medicine Pharmacology

Tags

Anesthesia Cannabidiol Cannabinoid Cannabis Computer science Insomnia Internal medicine Medicine Melatonin Operating system Pharmacology Psychiatry Randomized controlled trial Receptor Sleep (system call) Sleep disorder

Substances

Cannabis Other

Conditions & symptoms

Sleep disorder Poor sleep