Tapering Strategies for Sleeping Pill Dependence

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Jewish Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

260 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for tapering strategies for sleeping pill dependence?

Research shows that combining gradual tapering of hypnotic medication with cognitive-behavioral therapy for insomnia (CBTI) is effective in helping patients reduce or stop their use of sleeping pills. Studies found that this combination improves sleep quality and reduces medication use more effectively than tapering alone. ^{1 2 3 4 5}

Is tapering off sleeping pills safe for humans?

Tapering off sleeping pills, especially when combined with cognitive behavioral therapy for insomnia (CBTI), is generally considered safe and can help reduce dependency. However, there are risks associated with hypnotic medications, such as increased risk of falls, memory impairments, and rare but serious adverse events like severe allergic reactions and complex sleep-related behaviors. ^{1 2 3 6 7}

How does the treatment for sleeping pill dependence differ from other treatments?

The treatment for sleeping pill dependence involves a unique approach of combining gradual tapering of hypnotic medication with cognitive-behavioral therapy for insomnia (CBTI), which has shown to be more effective than tapering alone. Additionally, a novel 'blinded tapering' method, where patients are unaware of their specific tapering schedule, aims to reduce withdrawal expectations and improve discontinuation success. ^{1 2 3 4 5}

Research Team

Jack D Edinger, PhD

Principal Investigator

National Jewish Health

Fredrick Wamboldt, M.D.

Principal Investigator

National Jewish Health

Eligibility Criteria

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

You have tried to stop taking sleep medication before, but it didn't work.

I am currently taking medication for insomnia at bedtime.

I have been using medication for my condition almost every night for the past year.

Exclusion Criteria

You usually go to bed after 2:00 AM or wake up after 10:00 AM.

My mental health is stable, and my medications haven't changed recently.

I have been diagnosed with a psychotic or bipolar disorder in my lifetime.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete pre-intervention baseline measures

1 week

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

6 weeks

Weekly in-person sessions

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

10 weeks

Follow-up

Participants are monitored for hypnotic discontinuation rates and secondary outcomes such as sleep quality and quality of life

6 months

3-month and 6-month follow-up visits

Treatment Details

Interventions

• Hypnotic Medication

Trial Overview The study tests two ways of stopping sleep meds while getting Cognitive Behavioral Therapy for Insomnia (CBTI). One group knows when their medication dose is reduced (open-label taper), the other doesn't (blinded taper). The goal is to see which method helps more people successfully quit these meds.

Participant Groups

Group I: Blinded Hypnotic Medication Taper (BT) Experimental Treatment 1 Intervention

Participants assigned to the Blinded Taper group will not know the medication dose they receive during the Structured Medication Taper (SMT) phase.

Group II: Open-Label Hypnotic Medication Taper (OLT) Active Control 1 Intervention

Participants assigned to the Open-Label Hypnotic Medication Taper group will know the medication dose they receive during the SMT phase.

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Discontinuation of benzodiazepines among older insomniac adults treated with cognitive-behavioural therapy combined with gradual tapering: a randomized trial. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Hypnotic Discontinuation Using a Blinded (Masked) Tapering Approach: A Case Series. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence to behavioral recommendations of cognitive behavioral therapy for insomnia predicts medication use after a structured medication taper. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hypnotic taper with or without self-help treatment of insomnia: a randomized clinical trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Management of Hypnotic Discontinuation in Chronic Insomnia. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative tolerability of newer agents for insomnia. [2021]