Kayumov L, Brown G, Jindal R, Buttoo K, Shapiro C M
Department of Psychiatry, University of Toronto, and University Health Network, Toronto Western Hospital, Ontario, Canada.
Psychosom Med. 2001 Jan-Feb;63(1):40-8. doi: 10.1097/00006842-200101000-00005.
The effects of exogenous melatonin on sleep, daytime sleepiness, fatigue, and alertness were investigated in 22 patients with delayed sleep phase syndrome whose nocturnal sleep was restricted to the interval from 24:00 to 08:00 hours. This study was a randomized, double-blind, placebo-controlled crossover trial. Subjects received either placebo or melatonin (5 mg) daily for 4 weeks, underwent a 1-week washout period, and then were given the other treatment for an additional 4 weeks. Patients could take the melatonin between 19:00 and 21:00 hours, which allowed them to select the time they felt to be most beneficial for the phase-setting effects of the medication.
Two consecutive overnight polysomnographic recordings were performed on three occasions: at baseline (before treatment), after 4 weeks of melatonin treatment, and after 4 weeks of placebo treatment.
In the 20 patients who completed the study, sleep onset latency was significantly reduced while subjects were taking melatonin as compared with both placebo and baseline. There was no evidence that melatonin altered total sleep time (as compared with baseline total sleep time), but there was a significant decrease in total sleep time while patients were taking placebo. Melatonin did not result in altered scores on subjective measures of sleepiness, fatigue, and alertness, which were administered at different times of the day. After an imposed conventional sleep period (from 24:00 to 08:00), subjects taking melatonin reported being less sleepy and fatigued than they did while taking placebo.
Melatonin ameliorated some symptoms of delayed sleep phase syndrome, as confirmed by both objective and subjective measures. No adverse effects of melatonin were noted during the 4-week treatment period.
在22例睡眠时相延迟综合征患者中研究外源性褪黑素对睡眠、日间嗜睡、疲劳和警觉性的影响，这些患者的夜间睡眠被限制在00:00至08:00之间。本研究为一项随机、双盲、安慰剂对照的交叉试验。受试者每天接受安慰剂或褪黑素（5毫克）治疗，为期4周，经过1周的洗脱期，然后再接受另一种治疗4周。患者可在19:00至21:00之间服用褪黑素，这使他们能够选择自己认为对药物相位设定效果最有益的时间。
在三个时间点进行连续两次夜间多导睡眠图记录：基线（治疗前）、褪黑素治疗4周后和安慰剂治疗4周后。
在完成研究的20例患者中，与安慰剂和基线相比，服用褪黑素时入睡潜伏期显著缩短。没有证据表明褪黑素改变了总睡眠时间（与基线总睡眠时间相比），但患者服用安慰剂时总睡眠时间显著减少。褪黑素并未导致不同时间进行的嗜睡、疲劳和警觉性主观测量得分的改变。在规定的常规睡眠时间（0:00至08:00）后，服用褪黑素的受试者报告的嗜睡和疲劳程度低于服用安慰剂时。
客观和主观测量均证实，褪黑素改善了睡眠时相延迟综合征的一些症状。在4周治疗期间未观察到褪黑素的不良反应。
