Next-day Behavioral Effects of Trazodone

曲唑酮的第二天行为影响

• 批准号: 7532616
• 负责人: ANTHONY LIGUORI
• 金额: $ 19.98万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-13 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7532616
• 关键词: Accidents; Acute; Adverse effects; Automobile Driving; Behavioral; Belief; Chronic; Controlled Study; Coupled; Data; Deterioration; Development; Dose; Equilibrium; Goals; Grant; Growth; Hip Fractures; Measures; Memory; Mental Depression; Musculoskeletal Equilibrium; Outcome Measure; Patients; Perception; Performance; Pharmaceutical Preparations; Physicians; Physiological; Placebos; Polysomnography; Primary Insomnia; Provider; Public Health; Publishing; Reaction Time; Reporting; Risk; Shapes; Simulate; Sleep; Sleeplessness; Standards of Weights and Measures; Time; Trazodone; day; design; falls; hypnotic; improved; long term memory; placebo controlled study; prescription document; prescription procedure; size; sleep onset; vehicular accident

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.

描述（由申请人提供）：曲唑酮，在美国使用最广泛的睡眠辅助剂，适用于抑郁症，不适用于失眠症。影响曲唑酮作为睡眠辅助剂使用的因素尚不清楚，但据推测包括医生对标准催眠药监管限制的谨慎，以及提供者未经证实的曲唑酮安全有效的信念。标准催眠药与福尔斯、机动车事故、反应时间延迟、白天嗜睡和记忆问题的风险增加有关。医生对曲唑酮的处方优于批准的催眠药，表明医生可能认为曲唑酮是催眠药的更安全的替代品。这是一个重要且尚未回答的问题，因为在失眠症患者中尚未系统研究睡前服用曲唑酮的风险。这项资助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的替代品。将在受试者内设计中比较曲唑酮的常规初始催眠剂量50 mg与安慰剂。所有给药均在睡前进行。本开发性和探索性建议将估计睡前给药后早晨和曲唑酮稳态时观察到的各种不良反应的效应量。结果指标包括近端强度、姿势平衡、模拟驾驶性能、次日生理睡眠倾向、顺行性文字记忆和急性主观和多导睡眠图催眠功效。这些目标的完成将有助于改善公共卫生，澄清存在或不存在与这种经常处方的睡眠辅助相关的可能风险。最终，这些结果可能会改变这种无害的化合物的认知和处方。公共卫生相关性：这些项目目标的完成将有助于改善公共卫生，澄清是否存在与这种经常处方的助眠剂相关的可能风险。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。