Radicle Science, Encinitas, California, USA.
Center for Neuroscience, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
J Am Nutr Assoc. 2024 Jan;43(1):1-11. doi: 10.1080/27697061.2023.2203221. Epub 2023 May 10.
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.
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.
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 ( < 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.
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.
关于大麻二酚（CBD）用于睡眠的临床证据仍然有限。测试用于睡眠的 CBD 产品中发现的大麻素配方的比较有效性的研究更少，也没有研究它们与褪黑素等其他补充疗法相比如何。
参与者（N=1793 名有睡眠障碍症状的成年人）被随机分配接受 4 周剂量的 6 种产品（均为胶囊）中的 1 种，每种产品均含有 15mg CBD 或 5mg 褪黑素，单独或与少量大麻素联合使用。使用通过每周在线调查进行的患者报告的结局测量信息系统（PROMIS™）睡眠障碍 SF 8A 在 5 周的时间内（基线周和产品使用的 4 周）评估睡眠障碍。使用线性混合效应回归模型评估每个活性产品组与 CBD 分离物之间随时间变化的睡眠障碍变化的差异。
所有配方均表现出良好的安全性（12%的参与者报告有副作用，且均不严重），并显著改善了睡眠障碍（组内比较<0.001）。所有配方中，大多数参与者（56%至 75%）的睡眠质量均有明显改善。然而，在 15mg CBD 分离物与含有 15mg CBD 和 15mg大麻酚（CBN）的配方之间，无论是单独使用还是与 5mg大麻色烯（CBC）联合使用，在效果上没有显著差异。在 15mg CBD 分离物与含有 5mg 褪黑素的配方之间，无论是单独使用还是与 15mg CBD 和 15mg CBN 联合使用，在效果上也没有显著差异。
我们的研究结果表明，慢性使用低剂量 CBD 是安全的，可能会改善睡眠质量，但这些效果并不超过 5mg 褪黑素。此外，添加低剂量的 CBN 和 CBC 可能不会改善含有 CBD 或褪黑素分离物的配方的效果。
