Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.

Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third "rarely" or "never" hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

Eszopiclone for the treatment of primary insomnia: a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials.

STUDY OBJECTIVE: In this study, we performed a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the efficacy and safety of eszopiclone for the treatment of primary insomnia. METHODS: We searched MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials and PubMed from inception to June 2018. Additionally, we searched the ClinicalTrials.gov trials register for other relevant trials. According to participants, intervention, comparison, outcome (PICO) criteria, studies were included that focused on: adults diagnosed with primary insomnia, aged 18-65 and > 65 years; eszopiclone for the treatment of primary insomnia; comparison were made between eszopiclone and placebo; as well as primary outcomes, secondary outcomes, and adverse effects. RESULTS: A total of six randomized trials involving 2809 patients with primary insomnia were included in our analysis. Our analysis suggested that eszopiclone was associated with significant improvements in subjective sleep latency, wake after sleep onset, number of awakenings, total sleep time at one week, two weeks, one month, three months and six months. Meanwhile, eszopiclone was associated with increased quality of sleep, ability to function, daytime alertness and sense of physical well-being at one week, one month, three months and six months. Dizziness and unpleasant taste were the most common adverse effects in elderly subgroup. Alternately, non-elderly patients may be more prone to adverse effects such as infection, pharyngitis, somnolence, unpleasant taste and dry mouth. CONCLUSION: This meta-analysis showed that eszopiclone is an effective and safe therapy option for patients with primary insomnia, especially in elderly patients. However, due to the high clinical heterogeneity in some outcomes, further standardized preparation, large-scale and rigorously designed trials are needed.

Cognitive behavioral therapy for insomnia combined with eszopiclone for the treatment of sleep disorder patients transferred out of the intensive care unit: A single-centred retrospective observational study.

Patients transferred out of the intensive care unit (ICU) are always impaired by sleep disorders. Cognitive behavioral therapy for insomnia (CBT-I) and eszopiclone are 2 commonly prescribed strategies for insomnia. In the current study, the effect of the combined application of the 2 methods on sleep disorders in ICU transferred out patients was assessed.Twenty-nine insomnia patients receiving combined treatment of CBT-I and eszopiclone and a corresponding number of patients treated with eszopiclone were collected. The incidence of discomfort experiences in ICU was recorded. Polysomnogram (PSG), Pittsburgh Sleep Quality Index (PSQI), self-rating anxiety scale (SAS), self-rating depression scale (SDS), and treatment emergent symptom scale (TESS) were used to assess the treatment efficacy and side effects.Hospitalization for over 7 days, use of benzodiazepines, and experiencing anxiety, insomnia, and mechanical ventilation increased chances of sleep disorders. The sleep latency, awakening time, and total sleep time were further improved in patients treated with the combined therapy than patients treated with eszopiclone (t = -2.334, -2.412, 2.383, P < .05). Similar changing pattern was observed for PSQI score (t = -2.262, P < .05). The improvement effect of the combined therapy on the sleep efficacy, SWS phase III, and rapid eye movement sleep was also significantly stronger (t = 2.112, 2.268, 2.311, P < .05). Moreover, the SAS and SDS scores in patients treated with the combined therapy decreased more than those of patients treated with eszopiclone.The efficacy of CBT-I combined with eszopiclone in the treatment of sleep disorders in ICU transferred out patients was better than eszopiclone.