The Safety and Comparative Effectiveness of Non-Psychoactive Cannabinoid Formulations for the Improvement of Sleep: A Double-Blinded, Randomized Controlled Trial.
Study Goal
The researchers aimed to compare the effectiveness of CBD, alone or combined with minor cannabinoids, versus melatonin for improving sleep disturbance in adults.
Results Summary
All CBD formulations were safe and improved sleep disturbance, but the effects did not surpass those of 5 mg melatonin. Adding minor cannabinoids (CBN, CBC) did not enhance the efficacy of CBD or melatonin.
Population
1,793 adults experiencing symptoms of sleep disturbance.
Effective Dosage
15 mg CBD or 5 mg melatonin, alone or with minor cannabinoids (capsules).
Duration
4 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
cannabidiol (CBD) | increase | sleep quality | adults experiencing symptoms of sleep disturbance | - | could improve | #1 |
15 mg CBD | increase | sleep disturbance | adults experiencing symptoms of sleep disturbance | - | led to significant improvements | #2 |
5 mg melatonin | increase | sleep disturbance | adults experiencing symptoms of sleep disturbance | - | led to significant improvements | #3 |
CBD isolate | increase | sleep disturbance | adults experiencing symptoms of sleep disturbance | - | led to significant improvements | #4 |
low dose of CBD | no change | - | - | - | is safe | #5 |
low doses of CBN and CBC | no change | effect of formulations containing CBD or melatonin isolate | - | - | may not improve | #6 |
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: All formulations exhibited a favorable safety profile (12% of participants reported a side effect and none were severe) and led to significant improvements in sleep disturbance ( 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.