Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT03034018
Eligibility Criteria:
Inclusion Criteria:
* Peri- or postmenopausal women
* DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
* Some awakenings co-occur with a hot flash
* Score on the Insomnia Severity Index (ISI) measure ≥15
* Hot flashes present, including at night
Exclusion Criteria:
* Diagnosis of other primary sleep disorders
* Shift workers
* Current or expected use of hypnotic medications
* Current major depressive episode
* Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
* Current alcohol/substance use disorder
* Obesity
* Renal or hepatic disease
* Pregnancy or breastfeeding
* Recent malignancy
* Recent surgery
* Neurological disorder or cardiovascular disease raising safety concerns
* Medical instability considered to interfere with study procedures
* Concomitant medications with drug interaction or co-administration concerns
* Contraindications or allergic responses to suvorexant
* Recent or planned travel across time zones
* Excessive coffee or cigarette use
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03034018
Study Brief:
Protocol Section:
NCT03034018