A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia (NCT07542756) | Clinical Trial Compass
RecruitingPhase 4
A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
United States1,200 participantsStarted 2026-05-01
Plain-language summary
The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Adults aged 18-80 years.
* Meet DSM-5 criteria for Insomnia Disorder.
* Score ≥15 on the Insomnia Severity Index (ISI).
* Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months.
* Willingness to discontinue use of all sleep-related medications prior to enrollment.
* Completion of a 2-week washout period before starting any study medication.
* Willingness to provide clinician assent for participation.
Exclusion Criteria
Patients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a history of suicidal attempts or current ideation, acute or chronic psychiatric or medical condition not controlled by therapy (according to their primary care physician), or current alcohol or drug misuse; or the diagnoses of (or high risk for) other sleep disorders, including circadian rhythm disorders (phase advance or phase delay syndromes), shift work related sleep disorder ("day sleepers" who work \~11pm to 7am) and those with rotating shiftwork schedules. To determine eligibility, all subjects will be screened using a multitier process including: an online screener; an intake interview; a review of the subjects EMR; and, finally, the receipt of the patient's PCP's assent. The following provides additional listing and details (AD) for the Exclusion Criteria:
General Considerations
* Age \< 18 or \> 80 years old
* Inade…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative treatment response rates during acute (1-month) treatment phase
Timeframe: From treatment initiation to 1 month after treatment initiation
2
Relative safety and tolerability based on side effects during acute (1-month) treatment phase
Timeframe: From treatment initiation to 1 month after treatment initiation
3
Relative effects on daytime symptoms and function during acute (1-month) treatment phase
Timeframe: From treatment initiation to 1 month after treatment initiation
4
Durability of treatment response during longer-term maintenance (1-6 months) treatment phase
Timeframe: From the start of the 2nd month after treatment initiation to 6 months after treatment initiation
5
Relative safety and tolerability based on side effects during longer-term maintenance (1-6 months) phase
Timeframe: From the start of the 2nd month after treatment initiation to 6 months after treatment initiation
6
Durability of effects on daytime symptoms and function during longer-term maintenance (1-6 months) phase
Timeframe: From the start of the 2nd month after treatment initiation to 6 months after treatment initiation