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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21MH082280-01A1
Application #
7532616
Study Section
Adult Psychopathology and Disorders of Aging Study Section (APDA)
Program Officer
Chavez, Mark
Project Start
2008-06-13
Project End
2010-03-31
Budget Start
2008-06-13
Budget End
2009-03-31
Support Year
1
Fiscal Year
2008
Total Cost
$199,800
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Physiology
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Roth, Alicia J; McCall, W Vaughn; Liguori, Anthony (2011) Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs. J Sleep Res 20:552-8