Treatment-seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients, short-term or intermittent use provides satisfactory insomnia relief. However, more than 65% of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. A sizable proportion of insomnia patients who participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment. However, it is difficult for most long-term hypnotic users to convert from use of medications to a self-management approach. Interventions that combine CBT-I with supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50% of patients who receive this assistance either fail to discontinue their hypnotics or return to them even if they do achieve short-term abstinence. Previous research provides only a rudimentary understanding of how to help long-term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBT-I techniques. Limitations of existing research include failure to consider how: (1) the pace of hypnotic withdrawal influences outcomes; (2) patient characteristics such as belief in the need for sleep medications, and anxiety sensitivity moderate outcomes; and (3) hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes. This R34 project will gather key pilot data to address these limitations. Specifically, this project will compare the currently recommended tapering pace (25% dose reduction every two weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering condition to determine the influence of tapering pace on outcomes. The study also will examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic withdrawal symptoms and level of sleep disturbance during withdrawal we be tested as mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be randomized to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be examined to assess their influence on outcomes. Primary outcomes will include drop-out rates and hypnotic discontinuation rates observed for each SMT pace. We will tally rates of those who achieve hypnotic dose reductions during SMT and those who return to hypnotic use by a 3-month follow-up as secondary endpoints. Results will inform a future R01-level clinical trial focusing on tapering pace, patient characteristics that moderate the effect of tapering pace, and psychophysiological processes that mediate the effect of tapering pace. This line of research will inform clinical practice by helping to refine guidelines for tapering pace so as to provide more successful, person-centered interventions.
Long-term reliance on sedative hypnotics is common but may represent suboptimal insomnia management for many individuals. Hypnotic discontinuation/reduction and conversion to self-management of insomnia is difficult for many long-term hypnotic users. Interventions that combine supervised medication tapering (SMT) and cognitive behavioral insomnia therapy (CBT-I) help some who wish to discontinue hypnotic, but long-term hypnotic abstinence evades many provided such interventions. This pilot R-34 project will examine how such factors as the pace of hypnotic withdrawal, persons' beliefs in their need for sleep medications and their levels of anxiety sensitivity and hypnotic withdrawal symptoms and changes in subjective/objective markers of sleep quality might determine successful hypnotic discontinuation. Results should lead to a larger R01 trial that will test person-centered hypnotic withdrawal interventions designed to improve treatment outcomes
| Edinger, Jack D (2016) Should we finally include quantitative criteria in our definition of insomnia? Sleep Med 26:69-70 |
