Eszopiclone versus zopiclone in the treatment of insomnia
| Autor: | Sergio Tufik, Lia Bittencourt, Luciano Ribeiro Pinto, Luciano Rotella Braga, Erika Treptow |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Insomnia PolysomnographySleep Disturbances Efficacy Polysomnography Dysgeusia Piperazines law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Sleep Initiation and Maintenance Disorders medicine Clinical endpoint Prevalence Zopiclone Humans Hypnotics and Sedatives Adults 030212 general & internal medicine Eszopiclone lcsh:R5-920 medicine.diagnostic_test Therapeutic effect Headache General Medicine Clinical Science Middle Aged Index Treatment Outcome Anesthesia Female medicine.symptom Psychology lcsh:Medicine (General) Azabicyclo Compounds Nightly Treatment 030217 neurology & neurosurgery Hypnotics medicine.drug |
| Zdroj: | Clinics, Vol 71, Iss 1, Pp 5-9 (2016) Clinics, Volume: 71, Issue: 1, Pages: 5-9, Published: JAN 2016 Repositório Institucional da UNIFESP Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP Clinics Clinics; v. 71 n. 1 (2016); 5-9 Clinics; Vol. 71 Núm. 1 (2016); 5-9 Clinics; Vol. 71 No. 1 (2016); 5-9 Universidade de São Paulo (USP) instacron:USP |
| ISSN: | 1980-5322 1807-5932 |
| Popis: | Associacao Fundo de Incentivo a Pesquisa (AFIP) 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. Universidade Federal de São Paulo (UNIFESP), Departamento de Psicobiologia, São Paulo/, SP, Brazil Universidade Federal de São Paulo (UNIFESP), Departamento de Psicobiologia, São Paulo/, SP, Brazil Web of Science |
| Databáze: | OpenAIRE |
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