The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
Summary
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.