Clinical trial to compare digital CBT-I, trazodone, and daridorexant for menopause-related insomnia symptoms
Background
Insomnia is a prevalent and often debilitating symptom for peri- and post-menopausal women, significantly impacting their quality of life. Hormonal fluctuations, particularly declining estrogen levels, can disrupt sleep architecture and thermoregulation, exacerbating sleep disturbances. While various pharmacological and non-pharmacological treatments exist, including sedatives like trazodone, novel orexin receptor antagonists such as daridorexant, and cognitive behavioral therapy for insomnia (CBT-I), there remains a critical need for comparative effectiveness data. This trial aims to provide direct comparisons to guide personalized treatment decisions for menopause-related insomnia.
Study Design
This 12-month clinical trial will compare three current insomnia therapies in peri- and post-menopausal women. Participants will be randomized to one of three arms: taking trazodone every night, taking daridorexant every night, or participating in an online behavioral program for insomnia (digital CBT-I). The study involves one in-person visit and seven virtual visits (phone calls) over the 12-month duration. Participants will wear a Fitbit and complete a daily sleep diary for at least four weeks, alongside filling out online surveys four times throughout the study period. Primary endpoints include improvements in insomnia symptoms and the safety profile of each treatment.
Why It Matters
This comparative effectiveness trial is crucial for advancing the management of menopause-related insomnia, offering direct insights into which commonly used therapies are most effective and safe. For clinicians, the findings will provide evidence-based guidance for tailoring treatment plans, potentially leading to more personalized and successful outcomes for patients. Understanding the differential efficacy and safety across diverse backgrounds, menopausal stages, and co-existing conditions (e.g., sleep apnea, mood disturbance) will be a significant practical takeaway. This research will inform future clinical protocols, potentially optimizing the choice between pharmacological agents like trazodone (a serotonin modulator) and daridorexant (an orexin receptor antagonist), or non-pharmacological digital CBT-I, ultimately improving the quality of life for millions of women.
insomnia
menopause
trazodone
daridorexant
cbti
clinical-trial