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Not yet taking people in United StatesPhase 2

Daridorexant sleep pill tested in alcohol use disorder with insomnia

Tests if daridorexant reduces drinking in insomnia plus alcohol use disorder.

Key facts

Who runs it
Sterling McPherson
Where
Spokane, United StatesSee the site
Trial code
Registry title
Daridorexant for People With Insomnia and Alcohol Use Disorder Study
Status
Not yet recruiting
Phase
Phase 2
People taking part
205 people, planned
Started
1 Sept 2026
Expected to end
Dec 2031
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Daridorexant
  • Placebo
  • Brief Counseling
  • MEMS and Medication Accounting
  • Contingency Management for Medication Adherence
Record updated
14 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with both alcohol use disorder (AUD) and insomnia who want treatment for both. It tests whether daridorexant, a sleep medicine, can reduce drinking compared with placebo.

Age
18 years and older
Sex
All sexes can join
Disease stage
Diagnosed insomnia disorder for at least 3 months, at least 3 nights a week, with an Insomnia Severity Index (ISI) score of 15 or more (moderate or severe). Diagnosed AUD, with 4 or more standard drinks on 4 or more occasions in the past 30 days.
Earlier treatment
People cannot join if they had any medicine for sleep or AUD in the past 30 days.
Biomarker or test result
Breath alcohol of 0.00 at consent. Women who can become pregnant need a negative blood pregnancy test at the start, must use reliable birth control and must not be breastfeeding.

Main reasons for not taking part

  • High risk of dangerous alcohol withdrawal, such as detox or a seizure in the last 12 months
  • Untreated severe substance use disorder other than nicotine
  • Suicide attempt in the last 2 years
  • Moderate liver problems that prevent taking the full dose of 50mg/day
  • History of narcolepsy or complex sleep behaviors with sleeping pills

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • DSM-5 diagnosis of an insomnia disorder (i.e., difficulty initiating/maintaining sleep, early morning awakening equal or greater than 3 nights a week for equal or greater than 3 months, daytime impairment, and exclusion of other causes)
  • Insomnia Severity Index (ISI) score equal or greater to 15 indicating the presence of moderate or severe insomnia
  • 4 or more standard drinks on 4 or more occasions in the past 30 days
  • Seeking insomnia and AUD treatment
  • Aged 18+ years
  • DSM-5 diagnosis of AUD
  • Ability to read and speak English
  • Breath Alcohol of 0.00 for informed consent
  • Ability to provide written informed consent
  • Non-lactating women of childbearing age using a reliable form of birth control with a negative serum pregnancy test at baseline

Who cannot take part

  • Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
  • Current DSM-5 diagnosis of sever substance use disorder that is not currently being treated, other than nicotine
  • Moderate hepatic impairment indicating an inability to receive the full dose of 50mg/day
  • History of narcolepsy or complex sleep behaviors with sedative-hypnotics
  • Any other medical (discernible by initial blood test) or psychiatric condition that our medical team determines would compromise safe participation
  • Receipt of any pharmacotherapy for sleep or AUD in the past 30 days
  • Suicide attempt in the last 2 years

Where in United States

  • WSU Research ClinicSpokane, United StatesContact: Research CoordinatorNo longer taking part

About the trial

What the trial wants to find out

The goal of this clinical trial is to see if a sleep medication, daridorexant (DTX), can help decrease drinking in people who have alcohol use disorder (AUD) and insomnia.

Read full original descriptionShow less

The main questions it aims to answer are:

* Can DTX decrease alcohol use in individuals with insomnia better than placebo? * Can DTX increase sleep time and other sleep related outcomes better than placebo?

Participants will:

* Take prescribed medication (DTX or Placebo based on which group they are randomized to). * Provide urine, breath, saliva, and blood samples. * Come in for bi-weekly (once every 2 weeks) in-person visits. * Answer questionnaires and surveys related to sleep, substance use, and physical/mental health. * Use an EEG headband to track brain activity at night. * Come in for 3 follow up visits one month, six months, and one year after treatment.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    Treatment: Placebo, Brief Counseling, MEMS and Medication Accounting, and Contingency Management for Medication Adherence

  • DaridorexantTreatment being tested

    Treatment: Daridorexant, Brief Counseling, MEMS and Medication Accounting, and Contingency Management for Medication Adherence

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework
Plain-language title
Daridorexant sleep pill tested in alcohol use disorder with insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
14 July 2026