Neurofunctional phenotyping to investigate the role of the orexin system at the intersection of opioid use disorder and insomnia: a protocol for a randomised, placebo-controlled clinical trial of lemborexant in patients with insomnia receiving buprenorphine.

ABSTRACT:

Introduction

Insomnia is a common complaint among patients with opioid use disorder (OUD) maintained on buprenorphine (BUP). However, people with OUD have historically been excluded from insomnia clinical trials, leaving clinicians without evidence-based treatment options for this patient population. Lemborexant, the Food and Drug Administration (FDA)-approved dual orexin receptor antagonist for the treatment of insomnia, was recently shown to be safe and tolerable among a sample of patients with insomnia who were maintained on BUP. We hypothesise that pharmacologically antagonising the orexin system with lemborexant may improve insomnia symptoms in individuals with OUD and also enhance BUP treatment benefits by improving performance in neurofunctional domains identified in the Nat

SUBMITTER: Marcus MM 

PROVIDER: S-EPMC12570903 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature