An open label pilot trial of suvorexant for the management of comorbid insomnia and alcohol use disorder
SAILOR (SuvorexAnt for Insomnia and aLcohOl use disordeR): An open label pilot feasibility trial of suvorexant for the management of comorbid insomnia and alcohol use disorder
Eastern Health
20 participants
Feb 1, 2026
Interventional
Conditions
Summary
This study aims to recruit participants with comorbid insomnia and AUD after completing a supervised alcohol withdrawal program (inpatient or outpatient) who are seeking to maintain abstinence post-detoxification. Potential participants will be recruited by advertising in participating hospital clinics, internet, as well as through hospital caseworkers and clinicians. Potentially eligible and interested individuals will then be asked to provide informed consent prior to undergoing a full eligibility assessment at a screening visit with a study medical officer. After eligibility is confirmed, participants will undergo a baseline visit, a study visit 7 days post-baseline, an end-of-treatment visit 14-days post-baseline, and a follow-up visit 21-days post-baseline. Study participants will self-administer suvorexant 20mg each evening for 14 days.
Eligibility
Inclusion Criteria9
- Moderate to severe Alcohol Use Disorder (AUD) within the past 12-months according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria.
- Recent (within 10 days of screening) supervised alcohol detoxification (inpatient or otherwise).
- At least 7 days and not more than 1 month since last alcoholic beverage intake at the time of study screening.
- Meet study criteria for insomnia, defined as an Insomnia Severity Index (ISI) score of 15 or more.
- Age 18-65 years at the time of enrolment.
- Body mass index > 30 at the time of screening
- Adequate cognition and English language skills to give valid consent and complete research interviews.
- Stable housing.
- Willingness to participate and give written informed consent.
Exclusion Criteria12
- Pregnancy or lactation (people of child-bearing capability will be advised to use reliable contraception during the study and a pregnancy test will be performed where necessary).
- Current use of antihistamines, strong or moderate inhibitors of CYP3A liver enzymes, strong CYP3A inducers, or digoxin and/ or other medications that are contraindicated with suvorexant (listed in the Exclusionary Medications document).
- Meeting DSM-5 criteria for any substance use disorder other than alcohol and/ or nicotine.
- Clinically significant or unstable systemic medical condition (e.g., cancer, end stage liver disease) or psychiatric disorder (e.g. a current major depressive disorder – informed by the BDI, severe anxiety – informed by the BAI, active suicide risk – informed by the SIDAS) that, in the opinion of the investigator, precludes study participation.
- Diagnosis of, or suspected sleep disorder other than insomnia (e.g. sleep apnoea defined by STOP-BANG score greater than or equal to 5, narcolepsy, restless legs syndrome)
- Any alcohol pharmacotherapy within 30 days prior to start of study treatment.
- Significant alcohol withdrawal [current Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score greater than or equal to 10]
- Severe hepatic or renal impairment [defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3× upper limit of normal (ULN), total bilirubin > 2× ULN, or creatinine > 1.5× ULN].
- Shift-worker.
- Inability to take oral medication.
- Known sensitivity to suvorexant.
- Currently participating in another clinical trial with an investigational drug.
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Interventions
An open label study investigating 20mg of suvorexant (oral tablet) once per evening, for 14 days. Intervention adherence will be assessed via pill count at Day 8 and Day 15. An initial screening visit will be conducted, a maximum of 14 days prior to enrolment in the study. During the Screening visit, potentially eligible individuals will be asked to provide informed consent prior to undergoing a full eligibility assessment at an appointment with a trial physician and study researcher at the study site.
Locations(1)
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ACTRN12625001226493