Howard Ryan, Roth Thomas, Drake Christopher L
From the Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI.
J Clin Psychopharmacol. 2014 Jun;34(3):369-73. doi: 10.1097/JCP.0000000000000136.
Armodafinil is a medication used to treat excessive sleepiness in individuals with shift work disorder (SWD). In the present study, we investigate whether armodafinil can normalize nocturnal sleepiness in a group of typical SWD patients.
Participants were 12 night workers (aged 33.8 ± 8.57 years, 7 female subjects) with excessive sleepiness (≥10 on the Epworth Sleepiness Scale; mean, 14.8 ± 3.16), meeting the International Classification of Sleep Disorders, Second Edition criteria for SWD, with no other sleep or medical disorders verified by polysomnogram. The multiple sleep latency test (MSLT) was not used as an entry criteria. Armodafinil was administered at 10:30 pm in a randomized, double-blind, placebo-controlled, crossover design with experimental nights separated by 1 week. Primary end point was the MSLT, with naps at 1:30, 3:30, 5:30, and 7:30 am. Other study measures included a sleepiness-alertness visual analog scale administered before each nap, and 2 computer-based performance tests evaluating attention and memory.
Subjects with SWD had a mean MSLT of 5.3 ± 3.25 minutes, indicating a mean level of pathological sleepiness. Armodafinil significantly improved MSLT score to 11.1 ± 4.79 minutes (P = 0.006). Subjective levels of alertness on the visual analog scale also improved (P = 0.008). For performance, reaction time to central (P = 0.006) and peripheral (P = 0.003) stimuli and free recall memory (P = 0.05) were also improved.
Armodafinil 150 mg administered at the beginning of a night shift normalizes nocturnal sleepiness in individuals with SWD unselected for objective sleepiness. Subjective measures of sleepiness and cognitive performance are also improved. This suggests that armodafinil can improve levels of nocturnal alertness to within normal daytime levels in the majority of patients with SWD.
阿莫达非尼是一种用于治疗轮班工作障碍（SWD）患者过度嗜睡的药物。在本研究中，我们调查了阿莫达非尼是否能使一组典型的SWD患者的夜间嗜睡恢复正常。
参与者为12名夜班工作者（年龄33.8±8.57岁，7名女性受试者），有过度嗜睡症状（爱泼沃斯嗜睡量表得分≥10分；平均为14.8±3.16分），符合《国际睡眠障碍分类》第二版中SWD的标准，经多导睡眠图检查未发现其他睡眠或医学疾病。多次睡眠潜伏期试验（MSLT）不作为入选标准。阿莫达非尼于晚上10:30给药，采用随机、双盲、安慰剂对照、交叉设计，试验夜间间隔1周。主要终点是MSLT，于凌晨1:30、3:30、5:30和7:30进行小睡。其他研究指标包括每次小睡前使用的嗜睡-警觉视觉模拟量表，以及两项评估注意力和记忆力的计算机性能测试。
SWD患者的平均MSLT为5.3±3.25分钟，表明存在病理性嗜睡的平均水平。阿莫达非尼显著提高了MSLT得分至11.1±4.79分钟（P = 0.006）。视觉模拟量表上的主观警觉水平也有所提高（P = 0.008）。在性能方面，对中央（P = 0.006）和外周（P = 0.003）刺激的反应时间以及自由回忆记忆（P = 0.05）也有所改善。
在夜班开始时服用150毫克阿莫达非尼可使未因客观嗜睡而被选择的SWD患者的夜间嗜睡恢复正常化。嗜睡的主观指标和认知表现也有所改善。这表明阿莫达非尼可使大多数SWD患者的夜间警觉水平提高到正常白天水平。
