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Orexin A 2019-07-01 ClinicalTrials

Suvorexant evaluated to improve sleep in **opioid use disorder** patients undergoing buprenorphine withdrawal

Medical Management of Sleep Disturbance During Opioid Tapering

Background

Opioid use disorder (OUD) is a significant public health crisis, and supervised withdrawal is a critical step towards recovery. However, severe sleep disturbances, including insomnia and fragmented sleep, are common during opioid tapering and post-tapering phases. These sleep issues contribute to patient discomfort, increase the risk of relapse, and hinder long-term abstinence. Current management strategies often fall short in effectively addressing these complex sleep disruptions. Targeting the orexin system, which plays a crucial role in wakefulness and arousal via orexin-1/2 receptors, offers a novel therapeutic avenue to restore sleep architecture and potentially improve treatment outcomes in this vulnerable population.

Study Design

This randomized, placebo-controlled, parallel-group, dose-finding clinical trial (NCT04262193) enrolled 37 patients with opioid use disorder seeking supervised withdrawal. Participants were admitted into a clinical research unit and stabilized on buprenorphine for three days before randomization. They then underwent a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Patients were randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO (specifically, suvorexant 20 mg/day PO was mentioned in a related description). The investigators hypothesized that one or both doses of suvorexant would improve total sleep time relative to placebo. A single follow-up session was scheduled 5-10 days post-discharge.

Why It Matters

Improving sleep quality during opioid withdrawal could significantly enhance patient comfort and reduce the likelihood of relapse, a major challenge in OUD treatment. If suvorexant proves effective, it could become a valuable adjunct therapy, making the arduous process of opioid tapering more tolerable and potentially increasing long-term abstinence rates. This study's dose-finding nature is crucial for establishing an optimal and safe suvorexant protocol for this specific patient population. Effectively managing sleep disturbances could stabilize patients during a critical recovery phase, improving adherence and long-term recovery outcomes.


suvorexant opioid-use-disorder sleep-disturbance opioid-withdrawal orexin-antagonist clinical-trial
Source: clinicaltrials:NCT03789214 · Ingested 2026-06-03 · Digest: gemini-2.5-flash