N/A N=188 Randomized Single-blind Treatment

Sleep Without Insomnia or The Use of Chronic Hypnotics

Sleep Initiation and Maintenance Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03687086 ↗

Enrolled (actual)

188

Serious AEs

2.1%

Results posted

Dec 2024

Primary outcome: Primary: Rates of Hypnotic Discontinuation — 64; 52 Participants — p=.039

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Program A (Other); Program B (Other)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Rates of Hypnotic Discontinuation	76; 62	0.001 sig
SECONDARY Insomnia Severity Index	7.36; 7.71	0.880
SECONDARY Insomnia Severity Index	7.36; 7.71	0.880
SECONDARY Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale	3.37; 3.33	0.843
SECONDARY Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale	3.37; 3.33	0.843
SECONDARY Rates of Hypnotic Discontinuation	76; 62	0.001 sig
SECONDARY Hypnotic Dose	1.05; 1.32	0.409
SECONDARY Hypnotic Dose	1.05; 1.32	0.409

Summary

Sleeping medications, called hypnotics, are often prescribed for insomnia and are associated with adverse health outcomes in older adults. Response rates to hypnotic discontinuation programs are often inadequate, and many patients eventually resume use of hypnotics, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Current programs focus on the tapering of hypnotics and/or the treatment of insomnia symptoms. These programs employ strategies such as supervised gradual taper, cognitive behavioral therapy targeting hypnotic withdrawal, and/or cognitive behavioral therapy for insomnia. Evidence suggests that another mechanism involving "placebo" effects may be a viable target for achieving and sustaining higher discontinuation rates. Cognitive expectancies play a key role in producing placebo effects, which are characterized as real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. In this study, investigators are comparing two programs for discontinuing hypnotic medications-a program that addresses placebo effects associated with hypnotic use and a program that does not address these effects.

Eligibility Criteria

Inclusion Criteria

Age >= 55 years
Use of lorazepam, alprazolam, temazepam,and/or zolpidem for current or prior insomnia symptoms 2 or more nights per week for at least 3 months
Current or prior insomnia symptoms
Available to attend weekly in-person sessions over 9 weeks

Exclusion Criteria

High risk for complications in outpatient hypnotic discontinuation program:

Seizure disorder
Supratherapeutic or high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night).
High baseline risk of complicated withdrawal;benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g.,seizure, delirium at baseline (prior to taper))
Polydrug use (e.g., chronic high dose opioids)
Unable to keep study medications in secure location
Evidence of prescription fraud (e.g., multiple prescriptions for same drug filled at multiple pharmacies during overlapping time periods, diversion)

Discontinuation of hypnotic not appropriate:

•Study-targeted hypnotic used to treat another clinical condition (e.g., panic disorder)

Poor candidate for cognitive behavioral therapy for insomnia:

Presence of bipolar disorder
Cognitive impairment (e.g., Mini-Mental State Examination = 15 and =30)
Medically/psychiatrically unstable (e.g., planned major surgery during the study period;psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
Unstable housing situation

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Data sourced from ClinicalTrials.gov (NCT03687086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.