Tapering Strategies for Sleeping Pill Dependence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores methods to help individuals stop relying on sleeping pills. It compares two dose-reduction strategies: one where participants know their dose and another where they do not. Both groups receive therapy to manage insomnia without medication. This trial suits individuals who have used sleeping pills most nights over the past year, wish to stop, and have previously attempted to quit without success. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
Yes, participants will need to stop taking their current sleeping pills as the trial is focused on helping them discontinue hypnotic use.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that many individuals who rely on sleeping pills can safely reduce their use by gradually decreasing the dosage. This reduction can occur without hospitalization.
However, long-term use of sleeping pills carries risks, including an increased chance of serious health issues. Therefore, it is important to seek a doctor's guidance when reducing these medications. Most people manage the process well, though experiences can vary.
In summary, while sleeping pills pose some risks, many can safely reduce their use with professional guidance.12345Why are researchers excited about this trial?
Researchers are excited about these tapering strategies for sleeping pill dependence because they offer innovative approaches to reducing medication use. Unlike simply cutting back on doses, the Open-Label Hypnotic Medication Taper (OLT) allows participants to know their medication dose, potentially empowering them and reducing anxiety about tapering. On the other hand, the Blinded Hypnotic Medication Taper (BT) keeps participants unaware of their dose changes, which may help minimize psychological dependence on the medication. These strategies aim to provide more effective, personalized ways to manage sleeping pill dependence, which is a significant step beyond current standard practices.
What evidence suggests that this trial's treatments could be effective for sleeping pill dependence?
Studies have shown that gradually reducing the use of sleeping pills, combined with Cognitive Behavioral Therapy for Insomnia (CBTI), can help people stop using these medications. Specifically, research found that supervised reduction led to a 90% decrease in the amount of benzodiazepines used and an 80% decrease in their frequency. Successfully stopping sleeping pills was linked to better sleep, less anxiety, and improved overall health. In this trial, participants will be assigned to different tapering strategies. One method, "blinded tapering," might make it easier to quit sleeping pills, as participants will not know the medication dose they receive. Another group will follow an open-label tapering strategy, where participants will know their medication dose. These findings suggest that a structured plan to slowly reduce sleeping pill use could be a good option for those wanting to cut back or stop altogether.678910
Who Is on the Research Team?
Jack D Edinger, PhD
Principal Investigator
National Jewish Health
Fredrick Wamboldt, M.D.
Principal Investigator
National Jewish Health
Are You a Good Fit for This Trial?
This trial is for adults who've been using certain sleep medications nightly for over a year, want to stop but have failed before. They must have mild insomnia without meds and can't join if they have unstable mental health issues, substance abuse (except hypnotics), severe illnesses like cancer or dementia, other untreated sleep disorders, or use meds that disrupt sleep.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete pre-intervention baseline measures
Treatment
Participants 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
Structured Medication Taper (SMT)
Participants undergo a 10-week SMT with either a blinded or open-label tapering protocol, reducing hypnotic medication doses by 25% every two weeks
Follow-up
Participants are monitored for hypnotic discontinuation rates and secondary outcomes such as sleep quality and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Hypnotic Medication
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Jewish Health
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator