Zolpidem Use and Risk of Fracture in Elderly Insomnia Patients

Abstract

ObjectivesTo evaluate the risk of fractures related with zolpidem in elderly insomnia patients.MethodsHealth claims data on the entire South Korean elderly population from January 2005 to June 2006 were extracted from the Health Insurance Review and Assessment Service database. We applied a case-crossover design. Cases were defined as insomnia patients who had a fracture diagnosis. We set the hazard period of 1 day length prior to the fracture date and four control periods of the same length at 5, 10, 15, and 20 weeks prior to the fracture date. Time independent confounding factors such as age, gender, lifestyle, cognitive function level, mobility, socioeconomic status, residential environment, and comorbidity could be controlled using the casecrossover design. Time dependent confounding factors, especially co-medication of patients during the study period, were adjusted by conditional logistic regression analysis. The odds ratios and their 95% confidence intervals (CIs) were estimated for the risk of fracture related to zolpidem.ResultsOne thousand five hundred and eight cases of fracture were detected in insomnia patients during the study period. In our data, the use of zolpidem increased the risk of fracture significantly (adjusted odds ratio [aOR], 1.72; 95% CI, 1.37 to 2.16). However, the association between benzodiazepine hypnotics and the risk of fracture was not statistically significant (aOR, 1.00; 95% CI, 0.83 to 1.21). Likewise, the results were not statistically significant in stratified analysis with each benzodiazepine generic subgroup.ConclusionsZolpidem could increase the risk of fracture in elderly insomnia patients. Therefore zolpidem should be prescribed carefully and the elderly should be provided with sufficient patient education.

Cognitive Behavioral Therapy in the Treatment of Insomnia

“…Low-strength evidence showed that eszopiclone decreased wake time after sleep onset more than placebo, but there was substantial heterogeneity between trials (I 2 = 70%). Within the two 6-month trials, Walsh et al 109 reported greater improvement in wake time after sleep onset with eszopiclone compared with placebo (mean difference of 18 minutes) and Krystal et al 108 reported eszopiclone was not more effective than placebo. …”

“…108 Neither 6-month trial reported evidence of tolerance or withdrawal symptoms following discontinuation. 108,109 Specific adverse effects associated with eszopiclone use were somnolence (9% vs. 3% for placebo), unpleasant taste (23% vs. 3%), and myalgia (9% vs. 4%).…”

“…109 Eszopiclone more often resulted in remission or no clinically significant insomnia compared with placebo, indicated by an ISI score <7 at endpoint (50% vs. 19%) (low strength evidence). The difference in the mean change of ISI scores from baseline at 12 weeks of was -4.6 points (95% CI, -5.3 to -3.9) but this difference did not reach our minimum important difference of 7 points, indicating 'responder' to treatment.…”

“…Participants were randomized to 2 mg 110 or 3 mg eszopiclone. [108][109][110] One trial lasted 6 weeks 110 and two lasted 6 months. 108,109 All trials reported industry sponsorship and had moderate risk of bias.…”

“…Three moderate risk of bias RCTs (n=1929) analyzed the efficacy of eszopiclone 2-3 mg daily [108][109][110] (Table 13). The mean age was 49 years; 63 percent were female.…”