Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
The Florey Institute of Neuroscience and Mental Health