Sleep Initiation and Maintenance DisordersSWITCHNCT03687086
Sleep Without Insomnia or The Use of Chronic Hypnotics
A study testing Program A and Program B in people with Sleep Initiation and Maintenance Disorders, run by University of California, Los Angeles at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Program A and Program B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2018to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 < 24)
- Sleep/wake difficulty is better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders
- Untreated sleep-disordered breathing (respiratory event index >= 15 and < 30 plus excessive daytime sleepiness, or REI >=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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Greater Los Angeles
Los Angeles, California, 90073
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills
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.
Read the detailed description
Investigators will complete a 5-year randomized trial, recruiting participants from two healthcare systems using a three-step screening process that minimizes time and travel burden to participants. Step 1 (identification of participants): Investigators will identify participants aged >= 55 years who have current prescriptions for lorazepam, temazepam, alprazolam, and/or zolpidem for >= 3 months. Investigators will use three sources to identify these patients: medication lists from electronic health records/administrative data, consults to insomnia clinic, and referrals from providers. The research team will mail a recruitment letter (with opt-out card) to patients identified from these sources. Step 2 (phone screening for current or prior insomnia and current hypnotic use); Patients who endorse a history of insomnia symptoms and current hypnotic use will be invited for an in-person screening. Step 3 (in-person screening for remaining eligibility criteria (and baseline assessments): After written consent, the in-person screening visit consists of a comprehensive sleep, mental health, and brief physical health assessment. Individuals who meet study criteria and agree to continue will be randomized to receive either the Program A (N=94) or Program B (N=94). The interventions are approximately 2 months. Following intention-to-treat principles, all randomized participants will complete an assessment immediately after the intervention ends and 6 months after completing treatment. Participants will be compensated monetarily for assessment visits. Investigators will measure hypnotic expectancies, hypnotic discontinuation, and insomnia severity post-treatment and at 6-months follow-up.
- Being tested
- Program A, Program B
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program AOther
Cognitive behavioral therapy type A plus medications prepared in packaging type A.
Program BOther
Cognitive behavioral therapy type B plus medications in packaging type B.
| Study group | Role | What they receive |
|---|---|---|
| Program A | Experimental | cognitive behavioral therapy type A plus medications in packaging type A Receives: Other: Program A |
| Program B | Active comparator | cognitive behavioral therapy type B plus medications in packaging type B Receives: Other: Program B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Hypnotic Discontinuation
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Measured: 6 months after treatment ends (which is an average of 8 months from randomization)
Secondary outcomes (7)
Insomnia Severity Index
Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms.
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: One week post intervention (which is an average of 9 weeks from randomization)
Insomnia Severity Index
Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms.
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: 6 months after treatment ends (which is an average of 8 months from randomization)
Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale
These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy). The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.
Measured: One week post intervention (which is an average of 9 weeks from randomization)
Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale
These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy).The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.
Measured: 6 months after treatment ends (which is an average of 8 months from randomization)
Rates of Hypnotic Discontinuation
The percentage of participants who had stopped taking a benzodiazepine or z-drug one week after the end of treatment . This outcome was measured with 7-day self-reported medication logs.
Measured: One week post intervention (which is an average of 9 weeks from randomization)
Hypnotic Dose
The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).
Measured: One week post intervention (which is an average of 9 weeks from randomization)
Hypnotic Dose
The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).
Measured: 6 months after treatment ends (which is an average of 8 months from randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start11 Dec 2018
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Virginia Commonwealth University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Constance Fung, MD, MSHS, University of California, Los Angeles
- Investigators
- Constance Fung, MD, MSHS, Principal investigator, UCLA, VA Greater Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687086
- Sponsor's protocol ID
- 18-001009
- Other IDs
- R01AG057929
- Acronym
- SWITCH
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2018
- Last updated
- 7 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Compliance at one of the sites is not permitting data sharing.
Publications
Ghadimi S, Erickson AJ, Vaughan M, Mitchell MN, Josephson K, Badr MS, Martin JL, Zeidler M, Alessi C, Fung CH. Sleep aid usage following benzodiazepine receptor agonist tapering and cognitive behavioral therapy for insomnia in middle-aged and older adults. J Clin Sleep Med. 2026 May 21;22(1):80. doi: 10.1007/s44470-026-00089-5.
PubMed 42168527Fung CH, Alessi C, Martin JL, Josephson K, Kierlin L, Dzierzewski JM, Moore AA, Badr MS, Zeidler M, Kelly M, Smith JP, Cook IA, Der-Mcleod E, Ghadimi S, Naeem S, Partch L, Guzman A, Grinberg A, Mitchell M. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456. doi: 10.1001/jamainternmed.2024.5020.
PubMed 39374004Ghadimi S, Grinberg A, Mitchell MN, Alessi C, Moore AA, Martin JL, Dzierzewski JM, Kelly M, Badr MS, Guzman A, Smith JP, Zeidler M, Fung CH. Sleep characteristics and use of multiple benzodiazepine receptor agonists in older adults. J Am Geriatr Soc. 2023 Dec;71(12):3924-3927. doi: 10.1111/jgs.18528. Epub 2023 Aug 1. No abstract available.
PubMed 37526436
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills
- ClinicalTrials.gov ID
- NCT03687086
- Acronym / sponsor ID
- SWITCH / 18-001009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Virginia Commonwealth University, National Institute on Aging (NIA)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 30 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators will complete a 5-year randomized trial, recruiting participants from two healthcare systems using a three-step screening process that minimizes time and travel burden to participants. Step 1 (identification of participants): Investigators will identify participants aged >= 55 years who have current prescriptions for lorazepam, temazepam, alprazolam, and/or zolpidem for >= 3 months. Investigators will use three sources to identify these patients: medication lists from electronic health records/administrative data, consults to insomnia clinic, and referrals from providers. The research team will mail a recruitment letter (with opt-out card) to patients identified from these sources. Step 2 (phone screening for current or prior insomnia and current hypnotic use); Patients who endorse a history of insomnia symptoms and current hypnotic use will be invited for an in-person screening. Step 3 (in-person screening for remaining eligibility criteria (and baseline assessments): After written consent, the in-person screening visit consists of a comprehensive sleep, mental health, and brief physical health assessment. Individuals who meet study criteria and agree to continue will be randomized to receive either the Program A (N=94) or Program B (N=94). The interventions are approximately 2 months. Following intention-to-treat principles, all randomized participants will complete an assessment immediately after the intervention ends and 6 months after completing treatment. Participants will be compensated monetarily for assessment visits. Investigators will measure hypnotic expectancies, hypnotic discontinuation, and insomnia severity post-treatment and at 6-months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program A | Experimental | Other: Program Acognitive behavioral therapy type A plus medications in packaging type A |
| Program B | Active comparator | Other: Program Bcognitive behavioral therapy type B plus medications in packaging type B |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program ACognitive behavioral therapy type A plus medications prepared in packaging type A. | Other | Program A |
| Program BCognitive behavioral therapy type B plus medications in packaging type B. | Other | Program B |
Primary outcome
Rates of Hypnotic Discontinuation
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
7 secondary outcomes
Insomnia Severity Index
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Insomnia Severity Index
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Rates of Hypnotic Discontinuation
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Hypnotic Dose
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Hypnotic Dose
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42168527Ghadimi S, Erickson AJ, Vaughan M, Mitchell MN, Josephson K, Badr MS, Martin JL, Zeidler M, Alessi C, Fung CH. Sleep aid usage following benzodiazepine receptor agonist tapering and cognitive behavioral therapy for insomnia in middle-aged and older adults. J Clin Sleep Med. 2026 May 21;22(1):80. doi: 10.1007/s44470-026-00089-5.
- Derived from this study: PubMed 39374004Fung CH, Alessi C, Martin JL, Josephson K, Kierlin L, Dzierzewski JM, Moore AA, Badr MS, Zeidler M, Kelly M, Smith JP, Cook IA, Der-Mcleod E, Ghadimi S, Naeem S, Partch L, Guzman A, Grinberg A, Mitchell M. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456. doi: 10.1001/jamainternmed.2024.5020.
- Derived from this study: PubMed 37526436Ghadimi S, Grinberg A, Mitchell MN, Alessi C, Moore AA, Martin JL, Dzierzewski JM, Kelly M, Badr MS, Guzman A, Smith JP, Zeidler M, Fung CH. Sleep characteristics and use of multiple benzodiazepine receptor agonists in older adults. J Am Geriatr Soc. 2023 Dec;71(12):3924-3927. doi: 10.1111/jgs.18528. Epub 2023 Aug 1. No abstract available.
- Individual participant dataSharing planned: No. Compliance at one of the sites is not permitting data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance Fung, MD, MSHS principal investigator
UCLA, VA Greater Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program A and Program B in people with Sleep Initiation and Maintenance Disorders, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Hypnotic Discontinuation (time frame: 6 months after treatment ends (which is an average of 8 months from randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687086, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.