Eszopiclone versus zopiclone in the treatment of insomnia
Clinics
;
71(1): 5-9, Jan. 2016. tab
Artículo
en Inglés
| LILACS
| ID: lil-771945
ABSTRACT
OBJECTIVE:
To determine the therapeutic effects of two selective GABA-A agonists, zopiclone and eszopiclone, in the treatment of insomnia.METHODS:
This study comprised a phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial. Patients were randomized to receive zopiclone 7.5 mg or eszopiclone 3 mg, both orally, for four weeks. In total, 199 patients were evaluated during two visits and then followed for at least six weeks. The primary endpoint was the Insomnia Severity Index after four weeks of treatment. Secondary endpoints were obtained through polysomnography data, including total sleep time, sleep latency and sleep efficiency. The frequency of adverse events was also analyzed. ClinicalTrials.gov NCT01100164.RESULTS:
The primary efficacy analysis demonstrated the non-inferiority of eszopiclone over zopiclone. Analysis of objective parameters assessed by polysomnography showed that eszopiclone increased total sleep time and also improved sleep efficiency. The safety profile of both study treatments was similar and the most common events reported in both groups were dysgeusia, headache, dizziness, irritability and nausea. Adverse events were observed in 223 patients, 109 (85.2%) in the eszopiclone group and 114 (87.7%) in the zopiclone group.CONCLUSION:
Based on the Insomnia Severity Index at the end of four weeks of treatment, eszopiclone demonstrated efficacy comparable to that of zopiclone in the treatment of insomnia, increasing total sleep time as well as sleep efficiency according to polysomnography.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Piperazinas
/
Compuestos de Azabiciclo
/
Eszopiclona
/
Hipnóticos y Sedantes
/
Trastornos del Inicio y del Mantenimiento del Sueño
Tipo de estudio:
Ensayo Clínico Controlado
Límite:
Adulto
/
Femenino
/
Humanos
/
Masculino
Idioma:
Inglés
Revista:
Clinics
Asunto de la revista:
Medicina
Año:
2016
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Universidade Federal de São Paulo (UNIFESP)/BR
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