Laboratory of Clinical Neurophysiology, Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil.
Sleep Med. 2013 Jan;14(1):20-3. doi: 10.1016/j.sleep.2012.09.003. Epub 2012 Dec 4.
To compare the efficacy of sublingual Zolpidem (5 and 10mg) to conventional oral Zolpidem (10mg).
This was an open, randomized, double-blind, double-dummy, controlled, and single center study. The study took place at the Laboratory of Clinical Neurophysiology and total number of participants was 58 volunteers completed the study whose demographics of age, gender, body mass index (BMI) were similar among everyone. Scores in Epworth, Pittsburgh, Beck and Hamilton Scales did not differ among groups. A model of transient insomnia was determined by the sleep anticipation in 120minute. Subjects were randomly divided in three groups for drug administration (5mSL; 10mgSL and 10mg oral), given in a single dose prior to polysomnography (PSG). Sleep parameters were assessed by PSG and post-sleep questionnaires.
A significant main treatment effect was evident considering the sleep onset latency (SOL) and persistent sleep latency (PSL). An earlier sleep onset was induced by SL Zolpidem 10mg (SOL=p<0.004; PSL=p<0.006) and SL Zolpidem 5mg (SOL=p<0.025; PSL=p<0.046) compared to oral Zolpidem 10mg. Subjects that received SL Zolpidem 10mg reported an earlier sleep onset (latency to sleep and latency until persistent sleep) when compared to subjects from other groups (p<0.005).
Sublingual Zolpidem, both 5 and 10mg, induced faster sleep initiation than 10mg oral Zolpidem. A subjective perception of earlier sleep onset was reported by subjects using SL 10mg.
比较舌下给予唑吡坦（5mg 和 10mg）与口服给予唑吡坦（10mg）的疗效。
这是一项开放、随机、双盲、双模拟、对照和单中心研究。研究地点在临床神经生理学实验室，共有 58 名志愿者完成了这项研究，他们的年龄、性别和体重指数（BMI）在组间相似。各组的 Epworth、匹兹堡、贝克和汉密尔顿量表评分无差异。通过 120 分钟的睡眠预期来确定短暂性失眠模型。受试者被随机分为三组进行药物给药（5mSL；10mgSL 和 10mg 口服），在多导睡眠图（PSG）前单次给药。通过 PSG 和睡眠后问卷评估睡眠参数。
考虑到睡眠潜伏期（SOL）和持续睡眠潜伏期（PSL），明显存在主要治疗效果。与口服唑吡坦 10mg 相比，SL 唑吡坦 10mg（SOL<p0.004；PSL<p0.006）和 SL 唑吡坦 5mg（SOL<p0.025；PSL<p0.046）诱导更早的睡眠开始。与其他组的受试者相比，接受 SL 唑吡坦 10mg 的受试者报告更早的睡眠开始（入睡潜伏期和持续睡眠潜伏期）（p<0.005）。
舌下给予唑吡坦，无论是 5mg 还是 10mg，均能比口服给予 10mg 唑吡坦更快地诱导睡眠。使用 SL 10mg 的受试者报告了更早的睡眠开始的主观感觉。
