Narayan Andrea J, Manning Brooke, Aitken Blair, Downey Luke A, Hayley Amie C
Centre for Mental Health and Brain Sciences, Swinburne University of Technology, Hawthorn, VIC, Australia.
Institute for Breathing and Sleep, Austin Hospital, Melbourne, VIC, Australia.
Clin Drug Investig. 2025 Jun 21. doi: 10.1007/s40261-025-01455-6.
Cannabinoid treatments are commonly used for sleep conditions, but the direct sedating effects of daytime treatment consumption and indirect effects on night-time sleep are unclear. This study measures the direct effects of low-dose cannabinoid treatments on daytime sleepiness and potential indirect night-time sleep effects in healthy adult, novice cannabis users.
Using a double-blind, randomised, placebo-controlled cross-over design, participants were orally administered a standardised dose of 1 mL oil containing THC:CBD ratios of either 1:1, 1:16 or a placebo over five weekly in-lab visits. Daytime sleepiness was measured at 40, 135 and 265 min post-dosing using the Karolinska Sleepiness Scale (KSS). Indirect night-time sleep effects on total sleep time (TST), sleep-onset latency (SOL), and number of awakenings after onset were measured using daily wrist-actigraphy and sleep-diary entries during the 7-day washout period between treatments.
Final analyses (N = 20) showed subjective sleepiness (KSS score) significantly increased (mean difference = 1.9, SE 0.25) from 40 min to 265 min post-treatment (p < 0.001). No significant differences were observed between treatments for KSS. Indirect sleep measures (TST, SOL, number of awakenings) showed no differences between treatments or over time (all p > 0.05).
Daytime consumption of low-dose cannabinoid oils did not induce direct sleepiness or indirect night-time effects post-dosing among adults. Future studies would benefit from exploring pharmacokinetics and the possibility of treatment amplification of daytime fatigue, mood and cognitive changes to assist the development of therapeutic guidelines for safe daytime medical cannabis use.
ACTRN12622001539729, 13 December 2022, prospectively registered.
大麻素疗法常用于睡眠状况，但日间治疗使用的直接镇静作用以及对夜间睡眠的间接影响尚不清楚。本研究测量低剂量大麻素疗法对健康成年、初次使用大麻者日间嗜睡的直接影响以及潜在的间接夜间睡眠影响。
采用双盲、随机、安慰剂对照交叉设计，在五次每周的实验室访视中，给参与者口服标准化剂量的1毫升油，其中四氢大麻酚（THC）与大麻二酚（CBD）的比例分别为1:1、1:16或安慰剂。使用卡罗林斯卡嗜睡量表（KSS）在给药后40、135和265分钟测量日间嗜睡情况。在各治疗之间的7天洗脱期内，使用每日腕部活动记录仪和睡眠日记记录来测量间接夜间睡眠对总睡眠时间（TST）、睡眠起始潜伏期（SOL）以及入睡后觉醒次数的影响。
最终分析（N = 20）显示，治疗后40分钟至265分钟，主观嗜睡（KSS评分）显著增加（平均差异 = 1.9，标准误0.25）（p < 0.001）。各治疗组之间的KSS评分无显著差异。间接睡眠指标（TST、SOL、觉醒次数）在各治疗组之间或随时间变化均无差异（所有p > 0.05）。
成人日间服用低剂量大麻素油在给药后未诱发直接嗜睡或间接夜间影响。未来的研究将受益于探索药代动力学以及治疗增强日间疲劳、情绪和认知变化的可能性，以协助制定安全的日间医用大麻使用治疗指南。
ACTRN12622001539729，2022年12月13日，前瞻性注册。
