Next-day Behavioral Effects of Trazodone

描述（由申请人提供）：曲唑酮是美国使用最广泛的助眠药物，适用于抑郁症，不适用于失眠。影响曲唑酮作为助眠剂使用的因素尚不清楚，但据推测，其中包括医生对标准催眠药监管限制的谨慎态度，以及提供者对曲唑酮安全有效的未经证实的信念。标准催眠药会增加跌倒、机动车事故、反应时间延迟、白天嗜睡和记忆问题的风险。医生对曲唑酮的优先处方优于经批准的催眠药物，这表明医生可能认为曲唑酮是一种更安全的催眠药物替代品。这是一个重要且未解决的问题，因为睡前服用曲唑酮的风险尚未对失眠症患者进行系统的调查。这项拨款的主要目的是检查曲唑酮在慢性失眠症患者中的事故风险替代物。曲唑酮通常的初始催眠剂量为50毫克，将在受试者内设计中与安慰剂进行比较。所有的剂量将在睡前进行。本发展和探索性提案将评估曲唑酮在就寝后早晨和稳定状态下的各种不良反应的效应大小。结果测量是近端强度、姿势平衡、模拟驾驶表现、第二天生理性睡眠倾向、顺行性言语记忆、急性主观和多导睡眠图催眠效果。这些目标的完成将有助于改善公众健康，通过澄清与这种经常开处方的助眠剂相关的可能风险的存在或不存在。最终，研究结果可能会改变人们对这种假定安全的化合物的看法和处方。公共卫生相关性：完成这些项目目标将有助于改善公众健康，因为它阐明了与这种经常开处方的助眠剂相关的可能风险是否存在。最终，结果可能会改变这种普遍接受的化合物的看法和处方。

DESCRIPTION (provided by applicant): Trazodone, the most widely used sleep aid in the U.S., is indicated for depression, and is not indicated for insomnia. The factors shaping the use of trazodone as a sleep aid are unknown, but have been speculated to include physician wariness over the regulatory limitations governing standard hypnotics, coupled with providers' unsubstantiated belief that trazodone is safe and effective. Standard hypnotics have been implicated in increased risk of falls, motor vehicle accidents, delayed reaction time, daytime sleepiness, and memory problems. The preferential prescription by physicians of trazodone over approved hypnotics suggests that physicians may believe trazodone is a safer substitute for hypnotic medication. This is an important and unanswered question as the risk of bedtime dosing of trazodone has not been systematically investigated in insomniacs. The primary goal of this grant is to examine surrogates of accident risk with trazodone in chronic insomniacs. The usual initial hypnotic dose of trazodone, 50 mg, will be compared with placebo in a within-subject design. All dosing will be conducted at bedtime. This Developmental and Exploratory Proposal will estimate the effect size of various adverse effects seen the morning after bedtime dosing and at steady state of trazodone. The outcome measures are proximal strength, postural equilibrium, simulated driving performance, next-day physiologic sleep tendency, anterograde verbal memory, and acute subjective and polysomnographic hypnotic efficacy. Completion of these aims will contribute to improved public health by clarifying the presence or absence of possible risks associated with this frequently prescribed sleep aid. Ultimately, the results may alter the perception and prescription of this putatively safe compound. PUBLIC HEALTH RELEVANCE: Completion of these project aims will contribute to improved public health by clarifying the presence or absence of possible risks associated with this frequently prescribed sleep aid. Ultimately, the results may alter the perception and prescription of this generally well-accepted compound.