Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Summary

Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse.

This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.

Conditions

• Insomnia
• Alcohol Use Disorder

Interventions

DRUG

Suvorexant 20 mg

Placebo controlled double blind suvorexant vs placebo

OTHER

placebo

Placebo controlled double blind suvorexant vs placebo

Sponsors & Collaborators

• St Vincent's Hospital Melbourne

  collaborator OTHER

• Melbourne Health

  collaborator OTHER

• The Florey Institute of Neuroscience and Mental Health

  lead OTHER

Principal Investigators

• Andrew Lawrence · Florey Institute of Neuroscience & Mental Health

• Yvonne Bonomo · St Vincent's Hospital Melbourne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-26

Primary Completion

2022-07-31

Completion

2022-07-31

FDA Drug

Yes

Countries

• Australia

Study Locations