Almeida Montes Luis G, Ontiveros Uribe Marta P, Cortés Sotres José, Heinze Martin Gerardo
Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Calzada México Xochimilco No. 101, San Lorenzo Huipulco, Tlalpan México DF, Mexico.
J Psychiatry Neurosci. 2003 May;28(3):191-6.
To assess the hypnotic effect of melatonin in patients with primary insomnia.
Ten patients (mean age 50 yr, range 30-72 yr) who met the DSM-IV criteria for primary insomnia received, in random order, 0.3 mg of melatonin, 1.0 mg of melatonin or placebo 60 minutes before bedtime. A crossover design was used so that each patient received each of the 3 treatments for a 7-day period (with a 5-day washout period between). After each 7-day treatment, night time electroencephalographic (EEG) records were collected, and each morning, subjects completed sleep logs and analogue-visual scales to document the amount and subjective quality of sleep.
There were no significant differences in sleep EEG, the amount or subjective quality of sleep or side effects between the placebo, 0.3-mg melatonin or 1.0-mg melatonin treatments.
Melatonin did not produce any sleep benefit in this sample of patients with primary insomnia.
评估褪黑素对原发性失眠患者的催眠效果。
10名符合《精神疾病诊断与统计手册》第四版（DSM-IV）原发性失眠标准的患者（平均年龄50岁，范围30 - 72岁），在睡前60分钟按随机顺序分别服用0.3毫克褪黑素、1.0毫克褪黑素或安慰剂。采用交叉设计，使每位患者接受这3种治疗，每种治疗为期7天（中间有5天的洗脱期）。每次7天治疗后，收集夜间脑电图（EEG）记录，并且每天早晨，受试者完成睡眠日志和视觉模拟量表，以记录睡眠量和主观睡眠质量。
安慰剂、0.3毫克褪黑素或1.0毫克褪黑素治疗之间，睡眠脑电图、睡眠量、主观睡眠质量或副作用方面均无显著差异。
在该原发性失眠患者样本中，褪黑素未产生任何助眠效果。
