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      Zolpidem and Gender : Are Women Really At Risk?

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          Abstract

          In 2013 the Food and Drug Administration (FDA) claimed the existence of new data showing women to be at risk for excessive daytime sedation and impaired driving proficiency following bedtime doses of zolpidem. The putative explanation was the reduced metabolic clearance of zolpidem and higher morning blood concentrations in women compared to men. The FDA acted to reduce the recommended dosage for women down to 50% of the dose for men. No other regulatory agency worldwide has taken similar action.

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          Digit Symbol Substitution Test

          Judith Jaeger (2018)
          Abstract Purpose/Background Development of the Digit Symbol Substitution Test (DSST) was initiated over a century ago as an experimental tool to understand human associative learning. Its clinical utility, owing to its brevity and high discriminant validity, was first recognized in the 1940s, and now the DSST is among the most commonly used tests in clinical neuropsychology. Methods Specific studies and articles were reviewed to illustrate what the test measures, to evaluate its sensitivity to change, and to discuss its use in clinical practice. Results The DSST is a valid and sensitive measure of cognitive dysfunction impacted by many domains. Performance on the DSST correlates with real-world functional outcomes (eg, the ability to accomplish everyday tasks) and recovery from functional disability in a range of psychiatric conditions including schizophrenia and major depressive disorder. Importantly, the DSST has been demonstrated to be sensitive to changes in cognitive functioning in patients with major depressive disorder and offers promise as a clinical decision-making tool for monitoring treatment effects in this and other disorders affecting cognition. Implications/Conclusions The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function across a wide range of clinical populations but has low specificity to determine exactly which cognitive domain has been affected. However, the DSST offers a practical and effective method to monitor cognitive functions over time in clinical practice.
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            National use of prescription medications for insomnia: NHANES 1999-2010.

            Suzanne M Bertisch, Shoshana Herzig, John Winkelman … (2014)
            To determine current patterns and predictors of use of prescription medications commonly used for insomnia (MCUFI) in the U.S.
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              Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration

              Tania Huedo-Medina, Irving Kirsch, Jo Middlemass … (2012)
              Objectives To investigate the effectiveness of non-benzodiazepine hypnotics (Z drugs) and associated placebo responses in adults and to evaluate potential moderators of effectiveness in a dataset used to approve these drugs. Design Systematic review and meta-analysis. Data source US Food and Drug Administration (FDA). Study selection Randomised double blind parallel placebo controlled trials of currently approved Z drugs (eszopiclone, zaleplon, and zolpidem). Data extraction Change score from baseline to post-test for drug and placebo groups; drug efficacy analysed as the difference of both change scores. Weighted raw and standardised mean differences with their confidence intervals under random effects assumptions for polysomnographic and subjective sleep latency, as primary outcomes. Secondary outcomes included waking after sleep onset, number of awakenings, total sleep time, sleep efficiency, and subjective sleep quality. Weighted least square regression analysis was used to explain heterogeneity of drug effects. Data synthesis 13 studies containing 65 separate drug-placebo comparisons by type of outcome, type of drug, and dose were included. Studies included 4378 participants from different countries and varying drug doses, lengths of treatment, and study years. Z drugs showed significant, albeit small, improvements (reductions) in our primary outcomes: polysomnographic sleep latency (weighted standardised mean difference, 95% confidence interval −0.57 to −0.16) and subjective sleep latency (−0.33, −0.62 to −0.04) compared with placebo. Analyses of weighted mean raw differences showed that Z drugs decreased polysomnographic sleep latency by 22 minutes (−33 to −11 minutes) compared with placebo. Although no significant effects were found in secondary outcomes, there were insufficient studies reporting these outcomes to allow firm conclusions. Moderator analyses indicated that sleep latency was more likely to be reduced in studies published earlier, with larger drug doses, with longer duration of treatment, with a greater proportion of younger and/or female patients, and with zolpidem. Conclusion Compared with placebo, Z drugs produce slight improvements in subjective and polysomnographic sleep latency, especially with larger doses and regardless of type of drug. Although the drug effect and the placebo response were rather small and of questionable clinical importance, the two together produced to a reasonably large clinical response.
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                Author and article information

                Journal
                Title: Journal of Clinical Psychopharmacology
                Abbreviated Title: Journal of Clinical Psychopharmacology
                Publisher: Ovid Technologies (Wolters Kluwer Health)
                ISSN (Print): 0271-0749
                Publication date Created: 2019
                Publication date (Print): 2019
                Volume: 39
                Issue: 3
                Pages: 189-199
                Article
                DOI: 10.1097/JCP.0000000000001026
                PubMed ID: 30939589
                SO-VID: 3625edcd-dabd-499f-816a-8809909c3f0f
                Copyright © © 2019
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