Suvorexant pilot trial aims to improve sleep, reduce craving, and normalize HPA axis in substance use disorder patients
Background
Insomnia is a pervasive and undertreated issue in patients undergoing rehabilitation for substance use disorders (SUDs), often correlating with heightened drug craving and increased risk of relapse. Both insomnia and SUDs are independently linked to elevated cortisol, indicating dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. The orexin system, particularly the orexin 1 receptor, is implicated in both sleep/wakefulness and craving. While Suvorexant, an orexin 1/2 receptor antagonist, is FDA-approved for primary insomnia, its efficacy in improving sleep and reducing craving in SUD patients, or its impact on the HPA axis, remains unknown.
Study Design
This pilot open trial aimed to determine the efficacy of Suvorexant in patients with substance use disorders (SUDs) and insomnia. The study's primary objectives included assessing improvements in sleep quality, measured through wrist actigraphy and the Insomnia Severity Index (ISI). Researchers also planned to evaluate changes in daily mood, stress, craving, and sleep using Ecological Momentary Assessment (EMA) data. Additionally, the trial sought to determine if Suvorexant treatment would decrease total daily salivary cortisol, with samples collected at five time points over two consecutive days at two different study intervals. The study also aimed to assess the abuse liability of Suvorexant using a modified assessment battery in SUD patients.
Results
This abstract outlines the aims of a pilot open trial, rather than presenting specific findings or numerical results. The study's primary objective was to determine if Suvorexant would improve sleep quality in patients with substance use disorders (SUDs), specifically by increasing total sleep time and reducing awakenings.
The trial aimed to assess whether Suvorexant could modulate physiological dysregulation by decreasing total daily salivary cortisol levels over the course of treatment. Researchers also sought to evaluate changes in subjective measures of mood, stress, craving, and sleep through
Ecological Momentary Assessment (EMA)data. A crucial aim was to determine if patients treated with Suvorexant would endorse scale items on a modified abuse liability assessment battery, addressing safety concerns in this vulnerable population. The abstract emphasizes that previous animal studies reportedOrexin 1 receptorantagonists could decrease craving and normalize theHPA axis, forming the basis for investigating these effects in human SUD subjects.
Key Findings
- Aimed to determine if Suvorexant improves sleep quality (total sleep time, awakenings) via
actigraphyandISIin SUD patients. - Sought to assess if Suvorexant treatment decreases total daily salivary cortisol levels over the study course.
- Investigated changes in daily mood, stress, craving, and sleep using
Ecological Momentary Assessment (EMA)data. - Aimed to determine if Suvorexant treatment in SUD patients endorses items on a modified abuse liability assessment.
Why It Matters
If the aims of this pilot trial are met, Suvorexant could emerge as a valuable adjunctive therapy for substance use disorder (SUD) patients struggling with insomnia and craving. Improving sleep quality and reducing craving could significantly lower relapse rates, a critical unmet need in SUD treatment. The potential normalization of the HPA axis by an orexin antagonist suggests a broader impact on stress response, which is often dysregulated in SUDs. For clinicians, this could mean a new, FDA-approved option to address a complex comorbidity. For individuals, it could offer a pathway to better sleep and reduced craving without the abuse liability concerns of traditional hypnotics, potentially integrating into existing rehabilitation protocols to enhance long-term recovery.
suvorexant
insomnia
substance-use-disorder
orexin-antagonist
sleep
craving