Phase 4 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 80 years of age
• People who have been formally diagnosed with Insomnia Disorder based on standard diagnostic guidelines (DSM-5)
• People who score 15 or higher on a standard insomnia questionnaire called the Insomnia Severity Index (ISI)
• People who have trouble falling asleep and/or staying asleep for at least 30 minutes, on 3 or more nights per week, for at least 3 months
• People who are willing to stop taking any sleep medications before joining the study
• People who are able to complete a 2-week period without sleep medications before the study begins
• People whose doctor is willing to confirm it is appropriate for them to take part

Who may not be able to join:

• People younger than 18 or older than 80 years of age
• People who are not able to understand English well enough to participate
• People who are not comfortable or able to use a smartphone, computer, tablet, or the internet
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• Women of childbearing age who are not using a reliable form of birth control
• People with an unstable or acute (sudden/active) mental health condition
• People with an unstable or serious medical condition or recent acute illness within the past month, as determined by their primary care doctor
• People with significant liver or kidney problems
• People with certain rare medical conditions called pheochromocytoma or porphyria (confirm with trial site)
• People with epilepsy or a seizure disorder
• People with glaucoma or difficulty urinating (urinary retention)
• People with increased pressure in the eyes (confirm with trial site)
• People diagnosed with alcohol or substance use disorder within the past 2 years
• People who are unable to avoid alcohol or substance use for at least 3 days in a row
• People with any history of breathing-related sleep problems, including sleep apnea or COPD
• People who work night shifts (approximately 11pm to 7am) and sleep during the day, or who work rotating shift schedules
• People with circadian rhythm sleep disorders, such as advanced or delayed sleep phase syndrome (confirm with trial site)
• People who regularly nap during the day for 1 hour or more, on 3 or more days per week
• People who have a known allergy or medical reason to avoid any of the study medications or similar medications
• People who are currently taking certain medications that affect the brain or nervous system and cannot stop them before the study (confirm with trial site)
• People who smoke heavily (one pack or more of cigarettes per day) or who cannot avoid smoking during the night
• People taking certain medications that interact with the study drugs (specifically strong CYP3A4 inhibitors) and who are unable or unwilling to stop them (confirm with trial site)
• People with a history of suicide attempts or who are currently having thoughts of suicide

Important: Always verify eligibility with the trial site directly before applying.