Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations.
OBJECTIVE
To evaluate 6 months' eszopiclone treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations.


METHODS
Randomized, double blind, controlled clinical trial.


METHODS
54 research sites in the U.S.


METHODS
830 primary insomnia patients who reported mean nightly total sleep time (TST) < or = 6.5 hours/night and/or mean nightly sleep latency (SL) >30 min.


METHODS
Eszopiclone 3 mg or matching placebo.


METHODS
Patient-reported sleep measures, Insomnia Severity Index, Medical Outcomes Study Short-Form Health Survey (SF-36), Work Limitations Questionnaire, and other assessments measured during baseline, treatment Months 1-6, and 2 weeks following discontinuation of treatment.


RESULTS
Patient-reported sleep and daytime function were improved more with eszopiclone than with placebo at all months (P <0.001). Eszopiclone reduced Insomnia Severity Index scores to below clinically meaningful levels for 50% of patients (vs 19% with placebo; P <0.05) at Month 6. SF-36 domains of Physical Functioning, Vitality, and Social Functioning were improved with eszopiclone vs placebo for the Month 1-6 average (P < 0.05). Similarly, improvements were observed for all domains of the Work Limitations Questionnaire with eszopiclone vs placebo for the Month 1-6 average (P <0.05).


CONCLUSIONS
This is the first placebo-controlled investigation to demonstrate that long-term nightly pharmacologic treatment of primary insomnia with any hypnotic enhanced quality of life, reduced work limitations, and reduced global insomnia severity, in addition to improving patient-reported sleep variables.
Walsh
James K
JK
Sleep Medicine and Research Center, St. John's/St. Luke's Hospitals and the Department of Psychology, Saint Louis University, St. Louis, MO 63017, USA. jwalsh@stlo.mercy.net
Krystal
Andrew D
AD
Amato
David A
DA
Rubens
Robert
R
Caron
Judy
J
Wessel
Thomas C
TC
Schaefer
Kendyl
K
Roach
James
J
Wallenstein
Gene
G
Roth
Thomas
T
D000328:Adult; D001143:Arousal / Q000187:drug effects; D053961:Azabicyclo Compounds; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000523:psychology; D012917:Social Adjustment; D014851:Wakefulness / Q000187:drug effects; D014938:Work Capacity Evaluation
D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; C515050:zopiclone
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