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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent 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 as cognitive behavioral insomnia therapy or Cognitive Behavioral Therapy For Insomnia (CBTI) achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control (CTRL) condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
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 or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent 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 as cognitive behavioral insomnia therapy or CBTI achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering or SMT have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control CTRL condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Participants will not have their soporific hypnotic medication dosage changed during a 20 week blinded tapering period
Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 20 week blinded tapering period.
Participants will have their soporific hypnotic medication dosage reduced by 10% every two weeks during a 20 week blinded tapering period.
National Jewish Health
Denver, Colorado, United States
Participant Dropout Rate As Assessed By Analysis of Participant Register
Measurement will be taken by analysis of participant register of the proportion of participants in each tapering group who drop out before the end of the 20-week tapering period.
Time frame: 20-week tapering phase
Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records
Measurement will be taken by analysis of study pharmaceutical records of the proportion of participants in each tapering group who achieve full withdrawal of their hypnotic medication at or before the end of the tapering protocol.
Time frame: 20-week tapering phase
Hypnotic Relapse Rate As Assessed by Analysis of Participant Reports
Measurement will be taken by analysis of participant reports of the proportion of participants in each tapering group who achieve medication abstinence but subsequently return to hypnotic use by the 3-month follow-up visit.
Time frame: Three-month follow-up phase
Time to Drop Out of the Tapering Protocol As Assessed by Analysis of Participant Register
Measurement will be taken by analysis of participant register and drop out dates of the time between the beginning of the 20-week and the effective date of participant drop out.
Time frame: 20-week tapering phase
Absolute Change/Reduction in Diazepam Equivalents of Medication Being Used Nightly As Assessed by Study Pharmaceutical Records
Measurement will be taken by analysis of study pharmaceutical records of the absolute change or reduction in diazepam equivalents of medication being used nightly by study participants.
Time frame: 20-week tapering phase and three-month follow-up phase
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