Inappropriate PrescribingSOMNUSNCT06640023
The Study in Outpatient Medicine Using Nudges to Improve Sleep
A study testing Z-drug Default Quantity and Redirection + Accountable Justification in people with Inappropriate Prescribing, run by University of Southern California at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if electronic health record (EHR) nudges (changes to the EHR that do not restrict freedom of choice or alter incentives) can reduce Z-drug prescribing in primary care clinics for patients with insomnia. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inappropriate Prescribing
- What is being tested?
- Z-drug Default Quantity and Redirection + Accountable Justification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient primary care clinician at Northwestern Medicine
Who cannot join
- Clinician participated in pilot study
- Clinician-investigator for this trial
- Visit involves patient with ICD-10 F31.X diagnosis code (bipolar disorder) present in the last year or on active problem list
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study in Outpatient Medicine Using Nudges to Improve Sleep: The SOMNUS Trial
The goal of this clinical trial is to learn if electronic health record (EHR) nudges (changes to the EHR that do not restrict freedom of choice or alter incentives) can reduce Z-drug prescribing in primary care clinics for patients with insomnia. The main questions it aims to answer are:
- Can Z-drug prescribing be reduced by setting the dispense quantity default of new Z-drug orders in the EHR to 10 pills with 0 refills?
- Can Z-drug prescribing be reduced by an EHR alert that suggests clinicians remove a Z-drug and/or add an evidence-based behavioral treatment for insomnia, followed by a request to justify their reasoning if the suggestion is not followed?
- Does combining these two nudges reduce Z-drug prescribing?
Read more
Researchers will compare each nudge individually and in combination to an guideline education control group to see if each nudge (separately and in combination) can reduce Z-drug prescribing.
Clinician-participants will:
- Complete an introductory educational module about treating insomnia and relevant EHR changes.
- Complete their routine patient visits.
- Either experience EHR changes when prescribing Z-drugs, including a Z-drug dispense quantity default of 10 pills for new orders, a prompt to remove or justify Z-drug orders, both, or neither.
- Conditions
- Inappropriate Prescribing
- Being tested
- Z-drug Default Quantity, Redirection + Accountable Justification
- Keywords
- Sleep Aids, Pharmaceutical, Zolpidem, zaleplon, Eszopiclone, Cognitive Behavioral Therapy, Insomnia, Clinical Decision-Making, Decision Support Systems, Clinical, Economics, Behavioral
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-drug Default QuantityBehavioural
For new orders of oral Z-drugs tablets (zolpidem, zolpidem CR, zaleplon, and eszopiclone), the EHR dispense quantity default will be changed to 10 pills with 0 refills for all dosage levels. Dispense quantities for Z-drug reorders and renewals will not be changed.
Redirection + Accountable JustificationBehavioural
For qualifying Z-drug orders, an EHR alert will suggest removing the Z-drug, adding a CBT-I referral, or both. If the alert recommendation is not followed, clinicians will be asked to provide a justification for their decision when the order is signed. The justification will display in the Encounter Report.
The alert suggestion depends on the recent history of Z-drug prescriptions for a given patient. When a Z-drug is being ordered for patients with 180 days supply of Z-drugs or fewer in the last 365 days, the alert will prompt removal of the Z-drug and addition of a CBT-I referral to the order. When a Z-drug is being ordered for patients with 181 days supply of Z-drugs or more in the last 365 days, the alert will only prompt addition of a CBT-I referral to the order.
If a CBT-I referral is already in the current order or has been ordered for a patient in the past 180 days, the alert to add a CBT-I referral to the order will not display.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Clinicians randomized to this arm receive guideline education prior to the trial. |
| Z-drug Default Quantity | Experimental | Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults. Receives: Behavioral: Z-drug Default Quantity |
| Redirection + Accountable Justification | Experimental | Clinicians randomized to this arm receive guideline education + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians. Receives: Behavioral: Redirection + Accountable Justification |
| Combined | Experimental | Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians Receives: Behavioral: Z-drug Default Quantity; Behavioral: Redirection + Accountable Justification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-drug pill count
Dose-equivalent Z-drug pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.
Measured: 36 months
Secondary outcomes (8)
Z-drug pill count among short-term users
Dose-equivalent Z-drug pill count prescribed at eligible encounters with short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in last 365 days) by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.
Measured: 36 months
Z-drug pill count among long-term users
Dose-equivalent Z-drug pill count prescribed at eligible encounters of long-term Z-drug use patients (greater than 180 days of Z-drugs prescribed in last 365 days) by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.
Measured: 36 months
CBT-I referrals
Number of patients who are referred to CBT-I from intervention start to 18 months after the intervention start.
Measured: 18 months
CBT-I referrals among short-term users
Number of short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in last 365 days) who are referred to CBT-I from intervention start to 18 months after the intervention start.
Measured: 18 months
CBT-I referrals among long-term users
Number of long-term Z-drug use patients (greater than 180 days of Z-drugs prescribed in last 365 days) who are referred to CBT-I from intervention start to 18 months after the intervention start.
Measured: 18 months
Monthly Z-drug pill count
Total monthly dose-equivalent Z-drug pill count prescribed by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.
Measured: 36 months
Benzodiazepine pill count
Dose-equivalent benzodiazepine pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.
Measured: 36 months
Z-drug guideline discordant duration
Proportion of eligible encounters when patients were prescribed more than 35 Z-drug pills for use within a 5 week period from 18 months prior to the intervention start to 18 months after the intervention start.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Dec 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Medicine, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jason Doctor, University of Southern California
- Investigators
- Jason Doctor, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640023
- Sponsor's protocol ID
- UP-23-00317
- Other IDs
- 1R01HL167023-01
- Acronym
- SOMNUS
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data as part of a HIPAA compliant limited data set may be shared with researchers under a signed Data Use Agreement.
Publications
Cloughesy JN, Linder JA, Knight TK, Persell SD, Sullivan MD, Meeker D, Brown T, Lee JY, Stewart EP, Fox CR, Goldstein NJ, Sumitro RG, Vitiello MV, Mack WJ, Doctor JN. The Study in Outpatient Medicine using Nudges to Improve Sleep (SOMNUS): study protocol for an 18-month factorial, cluster-randomized trial to increase guideline-concordant treatment of insomnia in primary care. Trials. 2025 Dec 23;27(1):85. doi: 10.1186/s13063-025-09385-6.
PubMed 41430294
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study in Outpatient Medicine Using Nudges to Improve Sleep: The SOMNUS Trial
- ClinicalTrials.gov ID
- NCT06640023
- Acronym / sponsor ID
- SOMNUS / UP-23-00317
- Conditions
- Inappropriate Prescribing
- Keywords
- Sleep Aids, Pharmaceutical, Zolpidem, zaleplon, Eszopiclone, Cognitive Behavioral Therapy, Insomnia, Clinical Decision-Making, Decision Support Systems, Clinical
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 444 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Northwestern Medicine, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if electronic health record (EHR) nudges (changes to the EHR that do not restrict freedom of choice or alter incentives) can reduce Z-drug prescribing in primary care clinics for patients with insomnia. The main questions it aims to answer are:
- Can Z-drug prescribing be reduced by setting the dispense quantity default of new Z-drug orders in the EHR to 10 pills with 0 refills?
- Can Z-drug prescribing be reduced by an EHR alert that suggests clinicians remove a Z-drug and/or add an evidence-based behavioral treatment for insomnia, followed by a request to justify their reasoning if the suggestion is not followed?
- Does combining these two nudges reduce Z-drug prescribing?
Researchers will compare each nudge individually and in combination to an guideline education control group to see if each nudge (separately and in combination) can reduce Z-drug prescribing.
Clinician-participants will:
- Complete an introductory educational module about treating insomnia and relevant EHR changes.
- Complete their routine patient visits.
- Either experience EHR changes when prescribing Z-drugs, including a Z-drug dispense quantity default of 10 pills for new orders, a prompt to remove or justify Z-drug orders, both, or neither.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Clinicians randomized to this arm receive guideline education prior to the trial. |
| Z-drug Default Quantity | Experimental | Behavioral: Z-drug Default QuantityClinicians randomized to this arm receive guideline education + 10 pill quantity defaults. |
| Redirection + Accountable Justification | Experimental | Behavioral: Redirection + Accountable JustificationClinicians randomized to this arm receive guideline education + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians. |
| Combined | Experimental | Behavioral: Z-drug Default Quantity, Behavioral: Redirection + Accountable JustificationClinicians randomized to this arm receive guideline education + 10 pill quantity defaults + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatient primary care clinician at Northwestern Medicine
Key exclusion criteria (3 listed)
- Clinician participated in pilot study
- Clinician-investigator for this trial
- Visit involves patient with ICD-10 F31.X diagnosis code (bipolar disorder) present in the last year or on active problem list
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 |
|---|---|---|
| Z-drug Default QuantityFor new orders of oral Z-drugs tablets (zolpidem, zolpidem CR, zaleplon, and eszopiclone), the EHR dispense quantity default will be changed to 10 pills with 0 refills for all dosage levels. Dispense quantities for Z-drug reorders and renewals will not be changed. | Behavioural | Combined, Z-drug Default Quantity |
| Redirection + Accountable JustificationFor qualifying Z-drug orders, an EHR alert will suggest removing the Z-drug, adding a CBT-I referral, or both. If the alert recommendation is not followed, clinicians will be asked to provide a justification for their decision when the order is signed. The justification will display in the Encounter Report. The alert suggestion depends on the recent history of Z-drug prescriptions for a given patient. When a Z-drug is being ordered for patients with 180 days supply of Z-drugs or fewer in the last 365 days, the alert will prompt removal of the Z-drug and addition of a CBT-I referral to the order. When a Z-drug is being ordered for patients with 181 days supply of Z-drugs or more in the last 365 days, the alert will only prompt addition of a CBT-I referral to the order. If a CBT-I referral is already in the current order or has been ordered for a patient in the past 180 days, the alert to add a CBT-I referral to the order will not display. | Behavioural | Combined, Redirection + Accountable Justification |
Primary outcome
Z-drug pill count
Time frame: 36 months
Dose-equivalent Z-drug pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.
8 secondary outcomes
Z-drug pill count among short-term users
Time frame: 36 months
Z-drug pill count among long-term users
Time frame: 36 months
CBT-I referrals
Time frame: 18 months
CBT-I referrals among short-term users
Time frame: 18 months
CBT-I referrals among long-term users
Time frame: 18 months
Monthly Z-drug pill count
Time frame: 36 months
Benzodiazepine pill count
Time frame: 36 months
Z-drug guideline discordant duration
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 41430294Cloughesy JN, Linder JA, Knight TK, Persell SD, Sullivan MD, Meeker D, Brown T, Lee JY, Stewart EP, Fox CR, Goldstein NJ, Sumitro RG, Vitiello MV, Mack WJ, Doctor JN. The Study in Outpatient Medicine using Nudges to Improve Sleep (SOMNUS): study protocol for an 18-month factorial, cluster-randomized trial to increase guideline-concordant treatment of insomnia in primary care. Trials. 2025 Dec 23;27(1):85. doi: 10.1186/s13063-025-09385-6.
- Individual participant dataSharing planned: Yes. Individual participant data as part of a HIPAA compliant limited data set may be shared with researchers under a signed Data Use Agreement.
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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.
Jason Doctor, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-drug Default Quantity and Redirection + Accountable Justification in people with Inappropriate Prescribing, run by University of Southern California at 1 site 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Z-drug pill count (time frame: 36 months). 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 NCT06640023, which also lists 1 linked publication.
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 26 Jun 2026.