Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.
Mental Illness Research, Education, and Clinical Center, VA Palo Alto Health Care System, Palo Alto, California.
JAMA Netw Open. 2020 Jun 1;3(6):e206614. doi: 10.1001/jamanetworkopen.2020.6614.
Many shift workers have difficulty sleeping during the daytime owing to an inappropriately timed circadian drive for wakefulness.
To determine whether a dual hypocretin receptor antagonist would enable shift workers to have more daytime sleep.
DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled randomized clinical trial included 2 weeks of baseline data and 3 weeks of intervention data, from March 2016 to December 2018. Individuals were recruited through poster advertisements in the broader San Francisco Bay area in California. From an initial voluntary recruitment cohort of 38 shift workers, 19 individuals with self-reported difficulty sleeping during the daytime following night work shift were included. Data were analyzed from Janaury to March 2019.
1 week of 10 mg suvorexant or placebo, titrated upward to 20 mg suvorexant or placebo for 2 additional weeks.
Objective (ie, actigraphy) and subjective (ie, sleep logs) measures of sleep.
Among 19 participants who completed the study (mean [SD] age, 37.7 [11.1] years; 13 [68%] men), 8 participants (42%) were assigned to the suvorexant group and 11 participants (58%) were assigned to the placebo group. Compared with individuals in the placebo group, individuals in the suvorexant group increased their objective total sleep time by a mean (SE) of 1.04 (0.53) hours (P = .05) at the end of 1 week of 10-mg doses and by 2.16 (0.75) hours (P = .004) by the end of the 2 weeks of 20-mg doses. Subjective sleep was similarly improved as, compared with the placebo group, individuals in the suvorexant group increased their subjective total sleep time by a mean (SE) of 2.08 (0.47) hours (P < .001) at the end of 1 week of 10-mg doses and by 2.97 (0.56) hours (P < .001) by the end of the 2 weeks of 20-mg doses. Physician ratings of daytime sleep aligned with these measures, as there was no change in the placebo group and a much improved change in the suvorexant group. No adverse events were reported in the suvorexant group.
This pilot study found that the use of a dual hypocretin receptor antagonist in shift workers under real-world conditions resulted in more than 2 extra hours of daytime sleep per episode. Future research should confirm this pilot finding in a larger sample size and examine whether, over the long term, use of this medication has a concomitant improvement in medical and psychiatric health as well as workplace performance and safety.
ClinicalTrials.gov Identifier: NCT02491788.
许多轮班工人由于昼夜节律驱动清醒的时间安排不当，白天难以入睡。
确定双重食欲素受体拮抗剂是否能使轮班工人在白天有更多的睡眠时间。
设计、设置和参与者：这是一项双盲、安慰剂对照的随机临床试验，包括 2 周的基线数据和 3 周的干预数据，时间为 2016 年 3 月至 2018 年 12 月。通过在加利福尼亚州旧金山湾区的海报广告招募个人。从最初自愿招募的 38 名轮班工人队列中，纳入了 19 名自述夜班后白天睡眠困难的个体。数据分析于 2019 年 1 月至 3 月进行。
1 周的 10mg 苏沃雷生或安慰剂，滴定至 20mg 苏沃雷生或安慰剂，再服用 2 周。
客观（即活动记录仪）和主观（即睡眠日志）睡眠测量。
在完成研究的 19 名参与者中（平均[SD]年龄 37.7[11.1]岁；13[68%]名男性），8 名参与者（42%）被分配到苏沃雷生组，11 名参与者（58%）被分配到安慰剂组。与安慰剂组相比，苏沃雷生组在 1 周 10mg 剂量结束时，客观总睡眠时间平均（SE）增加了 1.04（0.53）小时（P=0.05），在 2 周 20mg 剂量结束时增加了 2.16（0.75）小时（P=0.004）。主观睡眠也得到了类似的改善，与安慰剂组相比，苏沃雷生组在 1 周 10mg 剂量结束时主观总睡眠时间平均（SE）增加了 2.08（0.47）小时（P<0.001），在 2 周 20mg 剂量结束时增加了 2.97（0.56）小时（P<0.001）。医生对白天睡眠的评分与这些测量结果一致，因为安慰剂组没有变化，而苏沃雷生组则有明显改善。苏沃雷生组没有报告不良事件。
这项初步研究发现，在现实环境中，使用双重食欲素受体拮抗剂可使轮班工人白天的睡眠时间增加 2 个多小时。未来的研究应在更大的样本量中证实这一初步发现，并研究这种药物的长期使用是否会同时改善医疗和精神健康以及工作场所的表现和安全。
ClinicalTrials.gov 标识符：NCT02491788。
