Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Neurology Business Group, Eisai, Inc., Woodcliff Lake, NJ.
Sleep. 2019 Apr 1;42(4). doi: 10.1093/sleep/zsy260.
To assess potential effects of lemborexant on next-morning driving performance in adult and elderly healthy volunteers.
Randomized, double-blind, double-dummy, placebo and active-controlled, four period incomplete crossover study in 48 healthy volunteers (22 females), 23-78 years old. Participants were treated at bedtime for eight consecutive nights with two of three dose levels of lemborexant (2.5, 5, or 10 mg), zopiclone 7.5 mg (on the first and last night with placebo on intervening nights), or placebo. Driving performance was assessed in the morning on days 2 and 9 using a standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug-placebo differences in SDLP >2.4 cm were considered to reflect clinically meaningful driving impairment.
Mean drug-placebo differences in SDLP following lemborexant 2.5, 5, and 10 mg on days 2 and 9 were 0.74 cm or less. The upper bound of the 95% confidence intervals (CIs) for lemborexant treatment groups were all below 2.4 cm and the 95% CIs included zero, indicating that the effects were neither clinically meaningful nor statistically significant. Symmetry analysis further supported the lack of clinically meaningful impairment with lemborexant.
When assessed starting ~9 h after lemborexant administration at bedtime the previous night, there was no statistically significant or clinically meaningful effect on driving performance in healthy adults and elderly, as assessed by either mean differences in SDLP relative to placebo or symmetry analysis. In this study, lemborexant at doses up to 10 mg was well-tolerated.
clinicaltrials.gov, NCT02583451. https://clinicaltrials.gov/ct2/show/NCT02583451.
评估雷美替胺对成年和老年健康志愿者次日清晨驾驶表现的潜在影响。
在 48 名健康志愿者（22 名女性，23-78 岁）中进行了一项随机、双盲、双模拟、安慰剂和阳性对照、四周期不完全交叉研究。参与者连续 8 晚在睡前接受雷美替胺（2.5、5 或 10 mg）、佐匹克隆 7.5 mg（第一晚和最后一晚用安慰剂，中间几晚用安慰剂）或安慰剂治疗。在第 2 天和第 9 天的早晨，通过在正常交通中进行标准化高速公路驾驶测试来评估驾驶表现，测量侧向位置标准差（SDLP）。认为 SDLP 药物-安慰剂差异>2.4 cm 反映了临床上有意义的驾驶障碍。
雷美替胺 2.5、5 和 10 mg 组在第 2 天和第 9 天的 SDLP 药物-安慰剂平均差异均小于 0.74 cm。雷美替胺治疗组的 95%置信区间（CI）上限均低于 2.4 cm，95%CI 包含零，表明这些影响既无临床意义也无统计学意义。对称分析进一步支持雷美替胺无临床上有意义的损伤。
在前一天晚上睡前服用雷美替胺约 9 小时后评估，健康成年人和老年人的驾驶表现未受到药物的统计学显著或临床上有意义的影响，无论是通过与安慰剂相比 SDLP 的平均差异还是通过对称分析来评估。在这项研究中，雷美替胺的剂量高达 10 mg 是可以耐受的。
clinicaltrials.gov，NCT02583451。https://clinicaltrials.gov/ct2/show/NCT02583451。
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