Use of Blinded Tapering for Hypnotic Discontinuation
Use of Blinded Tapering for Hypnotic Discontinuation
The study will employ a randomized longitudinal clinical trial design to evaluate the
 relative efficacy of a blinded hypnotic tapering protocol when used in combination with
 therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic
 discontinuation rates. A blinded SMT+CBTI intervention will be compared to open-label
 SMT+CBTI.
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 hypnotic 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. Many 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. Our clinical and research observations
 suggest that psychological factors including sleep-related performance anxiety, low
 sleep-related self-efficacy and beliefs about needs for medications interact to lead to
 difficulties abstaining from hypnotic use. Moreover, our highly promising pilot data suggest
 that such factors may be mitigated by use of a blinded SMT protocol which appears to increase
 rates of medication abstinence. The current project will use a 2 x 4 randomized longitudinal
 clinical trial design to test the relative efficacy of our highly promising blinded tapering
 protocol, vis a vis open-label tapering, when combined with therapist delivered CBT-I. A
 sample of 260 will be enrolled, complete pre-intervention baseline measures and then be
 randomly assigned to: (1) a blinded hypnotic SMT + therapist delivered CBT-I; or (2)
 open-label tapering + CBT-I. During treatment all enrollees will first receive one on one
 treatment sessions with a trained CBT-I therapist over a 6 week period while maintaining
 baseline doses of their respective hypnotics. They then will begin a 10 week SMT during which
 they are provided a blinded or open-label tapering SMT protocol. During this phase they will
 have their hypnotic medication doses reduced by 25% every two weeks. Immediately after
 completing the SMT and again at 3- and 6-month follow-ups they will complete study outcome
 measures. The primary study outcome will be hypnotic discontinuance rates of the two
 treatment groups. Secondary outcomes include nights of hypnotic use per week, nightly average
 dosage of hypnotic used in diazepam equivalents as well as scores on sleep quality, daytime
 fatigue and quality of life. This study will lead to refining guidelines for tapering methods
 and providing a better understanding of treatment outcome predictors so as to provide more
 successful, person-centered interventions.
Inclusion Criteria:

 1. be currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia
 management;

 2. have been using one or more such agents at least 5 nights/week for at least the past
 12 months;

 3. express interest in discontinuing hypnotic use and learning to manage their insomnia
 without medications;

 4. report one or more failed attempts to discontinue hypnotic use in the past;

 5. provide written consent to participate.

 6. have an insomnia severity index score > 10 indicating at least mild insomnia symptoms
 without sleep medication

 Exclusion Criteria:

 1. an untreated, or unstable psychiatric disorder as suggested by current active symptoms
 or a medication regimen that has been changed within the past 2 months;

 2. a lifetime diagnosis of any psychotic or bipolar disorder

 3. an imminent risk for suicide

 4. evidence of alcohol or drug abuse (other than hypnotics) within the past year, since
 such abuse patterns suggest specialized substance abuse treatment may be indicated

 5. unstable or terminal physical illness (e.g., cancer), neurological degenerative
 disease (e.g., dementia) or sleep disruptive medical condition

 6. current use of medications known to cause insomnia (e.g., corticosteroids)

 7. screening evidence of circadian rhythm sleep disorder (e.g., delayed sleep phase
 syndrome) or other sleep disorder (e.g. narcolepsy, idiopathic hypersomnolence, Rapid
 Eye Movement (REM) behavior disorder) for which CBTI would not represent optimal
 therapy

 8. habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM;

 9. consuming > 2 alcoholic beverages/day or any cannabis products at least 5 times/week

 10. pregnant women or mothers with care-taking responsibilities for infants due to the
 sleep-disruption caused by such circumstances

 11. clinical or polysomnographic evidence of undiagnosed and untreated restless legs
 syndrome (RLS), sleep apnea or periodic limb movements (PLMS) that require alternative
 therapies and would limit participants' responses to CBTI