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Drug Class Review on Newer Sedative Hypnotics

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Drug Class Review on Newer Sedative Hypnotics Drug Class Review on Newer Sedative Hypnotics Final Report December 2005 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Susan Carson, MPH Po-Yin Yen, MS Marian S. McDonagh, PharmD Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2005 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved. Final Report Drug Effectiveness Review Project TABLE OF CONTENTS Introduction....................................................................................................................... 4 Scope and Key Questions ............................................................................................. 4 Methods.............................................................................................................................. 6 Literature Search........................................................................................................... 6 Study Selection ............................................................................................................. 6 Data Abstraction ........................................................................................................... 7 Validity Assessment...................................................................................................... 7 Data Synthesis............................................................................................................... 7 Results ................................................................................................................................8 Overview of included studies........................................................................................ 8 Key Questions 1 and 2. Benefits and Harms ..................................................................... 9 Summary of the Evidence............................................................................................. 9 Detailed Assessment ................................................................................................... 11 Zolpidem vs zaleplon............................................................................................ 11 Zolpidem vs zopiclone.......................................................................................... 17 Zolpidem vs eszopiclone....................................................................................... 18 Eszopiclone vs zaleplon........................................................................................ 23 Zaleplon vs zopiclone ........................................................................................... 24 Newer sedative hypnotics vs benzodiazepines ..................................................... 26 Newer sedative hypnotics vs trazodone................................................................ 27 Long-term effectiveness and safety ...................................................................... 27 Key Question 3. Subgroups .............................................................................................. 29 Summary of the Evidence........................................................................................... 29 Detailed Assessment ................................................................................................... 30 Older adults........................................................................................................... 30 Gender and Racial Groups.................................................................................... 30 Use in Pregnancy .................................................................................................. 30 Patients with Comorbid Conditions...................................................................... 30 References........................................................................................................................... 34 In-Text Tables Table 1. Newer sedative hypnotic drugs...................................................................... 5 Table 2. Total numbers of head-to-head trials of sedative hypnotics.......................... 8 Table 3. Median sleep latency in studies of zolpidem vs zaleplon............................ 12 Table 4. Median sleep duration in trials of zaleplon versus zolpidem....................... 13 Table 5. Median number of awakenings in studies of zaleplon vs zolpidem ............ 14 Table 6. Adverse events in head-to-head studies of zaleplon vs zolpidem ............... 16 Table 7. Objective wake time after sleep onset in placebo controlled studies of eszopiclone............................................................................................................ 23 Table 8. Summary of short-term efficacy by drug and outcome ............................... 25 Newer Sedative Hypnotics Page 2 of 595 Final Report Drug Effectiveness Review Project Figures Figure 1. Newer sedative hypnotics: Results of Literature Search............................. 44 Figure 2. Rebound sleep latency: zolpidem vs zaleplon............................................. 15 Figure 3. Sleep latency at one week in placebo controlled trials of zolpidem vs zaleplon................................................................................................................. 17 Figure 4. Sleep latency at one week in placebo controlled trials of zolpidem vs zopiclone............................................................................................................... 18 Figure 5. Objective WASO head to head comparison of eszopiclone vs zolpidem ... 19 Figure 6. Sleep outcomes at one week in placebo controlled trials of zolpidem vs eszopiclone............................................................................................................ 20 Figure 7. Sleep outcomes at one month in placebo controlled trials of zolpidem vs eszopiclone............................................................................................................ 22 Figure 8. Sleep latency at one week in placebo controlled trials of eszopiclone vs zaleplon................................................................................................................. 23 Figure 9. Sleep latency at one week in placebo controlled trials of zaleplon vs zopiclone............................................................................................................... 24 Appendices Appendix A. Literature search strategies.................................................................... 45 Appendix B. Quality assessment methods.................................................................. 46 Appendix C. Excluded trials....................................................................................... 50 Appendix D. Newer sedative hypnotics vs benzodiazepines...................................... 69 Evidence Tables Evidence Table 1. Head to head controlled trials: Efficacy........................................ 73 Evidence Table 2. Head to head controlled trials: Rebound Insomnia....................... 97 Evidence Table 3. Head to head controlled trials: Adverse Events.......................... 105 Evidence Table 4. Active controlled trials (Adults): Efficacy.................................. 119 Evidence Table 5. Active controlled trials (Adults): Rebound Insomnia................. 201 Evidence Table 6. Active controlled trials (Adults): Adverse Events...................... 224 Evidence Table 7. Active controlled trials (Older adults): Efficacy......................... 292 Evidence Table 8. Active controlled trials (Older adults): Rebound Insomnia........ 308 Evidence Table 9. Active controlled trials (Older adults): Adverse Events............. 313 Evidence Table 10. Active controlled trials (Other Subgroups): Efficacy ............... 326 Evidence Table 11. Active controlled trials (Other Subgroups): Rebound Insomnia .............................................................................................. 350 Evidence Table 12. Active controlled trials (Other Subgroups): Adverse Events ... 351 Evidence Table 13. Placebo controlled trials: Efficacy............................................ 366 Evidence Table 14. Placebo controlled trials: Rebound Insomnia ........................... 437 Evidence Table 15. Placebo controlled trials: Adverse Events ................................ 448 Evidence Table 16. Quality Assessment................................................................... 484 Evidence Table 17. Observational Studies ............................................................... 556 Evidence Table 18. Case Reports ............................................................................. 589 Newer Sedative Hypnotics Page 3 of 595 Final Report Drug Effectiveness Review Project INTRODUCTION Insomnia is a serious health problem that affects millions of people. Population surveys have estimated the prevalence of insomnia to be about 30% to 50% of the general population, but estimates vary depending on the methods and definitions used to define insomnia.1 About three-fourths
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