Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations.
Sleep
; 30(8): 959-68, 2007 Aug.
Article
em En
| MEDLINE
| ID: mdl-17702264
ABSTRACT
STUDY OBJECTIVES:
To evaluate 6 months' eszopiclone treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations.DESIGN:
Randomized, double blind, controlled clinical trial.SETTING:
54 research sites in the U.S. PATIENTS 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. INTERVENTION Eszopiclone 3 mg or matching placebo. MEASUREMENTS 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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Piperazinas
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Qualidade de Vida
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Avaliação da Capacidade de Trabalho
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Hipnóticos e Sedativos
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Distúrbios do Início e da Manutenção do Sono
Tipo de estudo:
Clinical_trials
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Qualitative_research
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article