Centre for Sleep Science, School of Human Sciences, University of Western Australia, Crawley, WA, Australia.
West Australian Sleep Disorders Research Institute, Department of Pulmonary Physiology and Sleep Medicine, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.
Sleep. 2021 Nov 12;44(11). doi: 10.1093/sleep/zsab149.
This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).
Co-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
Twenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (-5.07 units [95% CI: -7.28 to -2.86]; p = 0.0001) and self-reported SOL (-8.45 min [95% CI: -16.33 to -0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2 min [95% CI: -16.2 to -4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.
ANZCTR; anzctr.org.au; ACTRN12618000078257.
这项随机、双盲、安慰剂对照、交叉研究旨在评估每晚舌下给予大麻素提取物（ZTL-101）治疗慢性失眠（症状≥3 个月）的安全性和疗效。
主要研究终点是根据不良事件报告评估药物的安全性和整体失眠症状（失眠严重程度指数[ISI]）。次要终点包括：自我报告（睡眠日记）、活动记录仪衍生和多导睡眠图测量的入睡潜伏期（SOL）、睡眠后觉醒（WASO）、总睡眠时间（TST）、睡眠效率（SE）；以及自我报告的睡眠质量（sSQ）和醒来后感觉休息情况。计算安慰剂和 ZTL-101 之间的调整平均差异。
24 名随机参与者中的 23 名（n=20 名女性，平均年龄 53±9 岁）完成了方案。没有报告严重不良事件。报告了 40 例轻度、非严重的不良事件（36 例发生在 ZTL-101 期间），除 1 例外，所有不良事件均在夜间或醒来后不久得到解决。与安慰剂相比，ZTL-101 降低了 ISI（-5.07 单位[95%置信区间：-7.28 至-2.86]；p=0.0001）和自我报告的 SOL（-8.45 分钟[95%置信区间：-16.33 至-0.57]；p=0.04），并增加了自我报告的 TST（64.6 分钟[95%置信区间：41.70 至 87.46]；p<0.0001）、sSQ（0.74 单位[95%置信区间：0.51 至 0.97]；p<0.0001）和醒来时感觉休息情况（0.51 单位[95%置信区间：0.24 至 0.78]；p=0.0007）。ZTL-101 还降低了活动记录仪衍生的 WASO（-10.2 分钟[95%置信区间：-16.2 至-4.2]；p=0.002），并增加了活动记录仪衍生的 TST（33.4 分钟[95%置信区间：23.07 至 43.76]；p<0.001）和 SE（2.9%[95%置信区间：2.0 至 3.8]；p=0.005）。
每晚舌下给予大麻素提取物（ZTL-101）治疗 2 周可耐受良好，并改善慢性失眠症状患者的失眠症状和睡眠质量。
ANZCTR；anzctr.org.au；ACTRN12618000078257。
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