Treatment of insomnia in depressed insomniacs: effects on health-related quality of life, objective and self-reported sleep, and depression.
OBJECTIVE
Insomnia is associated with poor health related quality of life (HRQOL) in depressed patients. Prior clinical trials of hypnotic treatment of insomnia in depressed patients have shown improvement in HRQOL, but in these studies HRQOL was relegated to a secondary outcome, and objective measures of sleep were not undertaken.


METHODS
Double-blind, randomized, placebo-controlled clinical trial.


METHODS
Outpatient clinic and sleep laboratory.


METHODS
60 depressed, insomniac outpatients.


METHODS
One week of open-label fluoxetine (FLX), followed by 8 more weeks of FLX combined with either eszopiclone (ESZ) 3 mg or placebo at bedtime.


METHODS
The primary HRQOL measure was the daily living and role functioning subscale (DLRF) of the Basis-32. Other measures included the Q-LES-Q, self-reported sleep, PSG, actigraphy, depression severity (HRSD).


RESULTS
At the end of randomized treatment, patients receiving ESZ had lower (better) DLRF scores (0.81 +/- 0.64) than those receiving placebo (1.2 +/- 0.72), p = 0.01. The effect size for DLRF was 0.62, indicating a moderate effect. An advantage for ESZ was also seen in other measures of HRQOL, and most assessments of antidepressant efficacy and sleep. Women reported better end of treatment HRQOL scores than men.


CONCLUSIONS
ESZ treatment of insomnia in depressed patients is associated with multiple favorable outcomes, including superior improvement in HRQOL, depression severity, and sleep.
McCall
W Vaughn
WV
Department of Psychiatry and Behavioral Medicine, Wake Forest University Health Sciences, Winston-Salem, NC 27157, USA. vmccall@wfubmc.edu
Blocker
Jill N
JN
D'Agostino
Ralph
R
Kimball
James
J
Boggs
Niki
N
Lasater
Barbara
B
Haskett
Roger
R
Krystal
Andrew
A
McDonald
William M
WM
Rosenquist
Peter B
PB
D000203:Activities of Daily Living / Q000523:psychology; D000339:Affect / Q000187:drug effects; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D053961:Azabicyclo Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000069582:Eszopiclone; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D017060:Patient Satisfaction; D010555:Personality Inventory; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000523:psychology*; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D005473:Fluoxetine; D000069582:Eszopiclone