The Study in Outpatient Medicine Using Nudges to Improve Sleep (SOMNUS)

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:

1. 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?
2. 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?
3. 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:

1. Complete an introductory educational module about treating insomnia and relevant EHR changes.
2. Complete their routine patient visits.
3. 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 Overview

• Status: Enrolling by invitation
• Conditions: Inappropriate Prescribing
• Intervention / Treatment: Behavioral: Z-drug Default Quantity; Behavioral: Redirection + Accountable Justification

• Study Type: Interventional
• Enrollment (Estimated): 444
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Outpatient primary care clinician at Northwestern Medicine

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Clinicians randomized to this arm receive guideline education prior to the trial.
Experimental: Z-drug Default Quantity; Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults.	Behavioral: Z-drug Default Quantity; 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.
Experimental: Redirection + Accountable Justification; 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.	Behavioral: Redirection + Accountable Justification; 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.
Experimental: Combined; 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	Behavioral: Z-drug Default Quantity; 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.; Behavioral: Redirection + Accountable Justification; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBT-I referrals	Number of patients who are referred to CBT-I from intervention start to 18 months after the intervention start.	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.	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.	18 months
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.	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.	36 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.	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.	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.	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBT-I referrals at follow-up	Number of patients who are referred to CBT-I from intervention start to 30 months after the intervention start.	30 months
CBT-I referrals at follow-up 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 30 months after the intervention start.	30 months
CBT-I referrals at follow-up 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 30 months after the intervention start.	30 months
Z-drug pill count at follow-up	Dose-equivalent Z-drug pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.	48 months
Z-drug pill count at follow-up among short-term users	Dose-equivalent Z-drug pill count prescribed at eligible encounters of short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in the last 365 days) by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.	48 months
Z-drug pill count at follow-up 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 the last 365 days) by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.	48 months
Monthly Z-drug pill count at follow-up	Total monthly dose-equivalent Z-drug pill count prescribed by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.	48 months
Benzodiazepine pill count at follow-up	Dose-equivalent benzodiazepine pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.	48 months
Z-drug guideline discordant duration at follow-up	Proportion of eligible encounters when patients were prescribed more than 35 Z-drug pills for at least 5 consecutive weeks from 18 months prior to the intervention start to 30 months after the intervention start.	48 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Northwestern Medicine
• Investigators: Principal Investigator: Jason Doctor, PhD, University of Southern California

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Insomnia; Cognitive Behavioral Therapy; Zolpidem; Eszopiclone; Decision Support Systems, Clinical; Clinical Decision-Making; zaleplon; Economics, Behavioral; Sleep Aids, Pharmaceutical
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Behavior
• Other Study ID Numbers: UP-23-00317; 1R01HL167023-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data as part of a HIPAA compliant limited data set may be shared with researchers under a signed Data Use Agreement.
• IPD Sharing Time Frame: Data will be available for one year following study completion date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No