Therapeutic efficacy of zolpidem combined with cognitive-behavioral therapy on primary insomnia

BACKGROUND: In this study, we intend to assess the efficacy of zolpidem combined with cognitive-behavioral therapy (CBT) for patients with primary insomnia (PI). METHODS: A predefined search strategy will be used to search for associated literature from inception to the July 1, 2019: PubMed, EMBASE, Cochrane Library, Scopus, Web of Science, Google Scholar, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure with no language limitation. In addition, we will also retrieve reference lists of included studies and relevant reviews, as well as the conference proceedings. All randomized controlled trials related to the zolpidem and CBT for PI will be included. Two authors will perform study selection, data collection, and study quality, respectively. We will also apply RevMan 5.3 software for statistical analysis. RESULTS: This study will provide a comprehensive overview of the available evidence of the benefits and safety of zolpidem and CBT for PI. Primary outcomes are sleep quality and severity of sleep disorders. Secondary outcomes consist of sleep-onset latency, total sleep duration, sleep efficiency, and frequency and adverse events. CONCLUSION: The results of this study will inform clinical and policy decisions regarding the benefits and harm of zolpidem and CBT for patients with PI. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019142796.