# Use of blinded tapering for hypnotic discontinuation

> **NIH NIH R01** · NATIONAL JEWISH HEALTH · 2023 · $366,012

## Abstract

PROJECT SUMMARY/ABSTRACT
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...

## Key facts

- **NIH application ID:** 10609458
- **Project number:** 5R01DA047341-05
- **Recipient organization:** NATIONAL JEWISH HEALTH
- **Principal Investigator:** Elizabeth Devon Smith
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $366,012
- **Award type:** 5
- **Project period:** 2019-07-01 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10609458

## Citation

> US National Institutes of Health, RePORTER application 10609458, Use of blinded tapering for hypnotic discontinuation (5R01DA047341-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10609458. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*