Eszopiclone versus zopiclone in the treatment of insomnia

Eszopiclone versus zopiclone in the treatment of insomnia

Author Pinto Júnior, Luciano Ribeiro Autor UNIFESP Google Scholar
Bittencourt, Lia Rita Azeredo Autor UNIFESP Google Scholar
Treptow, Erika Cristine Autor UNIFESP Google Scholar
Braga, Luciano Rotella Autor UNIFESP Google Scholar
Tufik, Sergio Autor UNIFESP Google Scholar
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.
Keywords Insomnia
Zopiclone
Eszopiclone
PolysomnographySleep Disturbances
Nightly Treatment
Hypnotics
Prevalence
Efficacy
Adults
Index
Language English
Sponsor Associacao Fundo de Incentivo a Pesquisa (AFIP)
Date 2016
Published in Clinics. Sao paulo, v. 71, n. 1, p. 5-9, 2016.
ISSN 1807-5932 (Sherpa/Romeo, impact factor)
Publisher Hospital clinicas, univ sao paulo
Extent 5-9
Origin http://dx.doi.org/10.6061/clinics/2016(01)02
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000370621800002
SciELO ID S1807-59322016000100005 (statistics in SciELO)
URI http://repositorio.unifesp.br/handle/11600/49606

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