Phase 3 Sleep Disorders Trial, Recruiting

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

Who might be able to join this trial:

• People between 20 and 60 years old
• People who have been working rotating shift schedules for at least 3 months and will continue doing so until the study ends
• People who have sleep problems, such as sleeping less than 6 hours total or not being able to sleep effectively, meeting at least one sleep disorder criterion from a standard diagnostic checklist (confirm with trial site)
• People who feel sleepy while working and score 10 points or higher on a standard daytime sleepiness questionnaire (the Epworth Sleepiness Scale, measured during shift hours)

Who may not be able to join:

• People taking certain medications that strongly or moderately interact with a liver enzyme called CYP3A4 (confirm with trial site for specific medicines)
• People with an untreated mental health condition, or whose mental health medication is currently being adjusted
• People with severe liver disease (classified as Child-Pugh C)
• People who are pregnant
• People who are breastfeeding
• People whose medications — such as those for mental health, neurology, insomnia, or contraception — are currently being adjusted
• People diagnosed with obstructive sleep apnea (with or without the use of a CPAP machine), restless leg syndrome, circadian rhythm disorders, or narcolepsy
• People who experience complex sleep behaviours such as driving, using a phone, or cooking while asleep
• People who score 24 or higher on a standard depression assessment scale (HAM-D)
• People who score 24 or higher on a standard anxiety assessment scale (HAM-A)
• People who consume more than 400 mg of caffeine per day, or who are unable to avoid caffeine in the 4 hours before sleeping
• People with a history of substance abuse or alcoholism within the past 2 years
• People whose weekly alcohol intake exceeds 140 g (for women) or 210 g (for men), or who cannot limit alcohol to less than 20 g on any single day, or who cannot avoid alcohol in the 3 hours before sleeping
• People who have used cannabis within the past week
• People with certain existing health conditions, including stroke, irregular heart rhythm (atrial fibrillation), chronic obstructive pulmonary disease, liver impairment, severe kidney impairment, cognitive impairment, cancer, or chronic pain
• People currently using benzodiazepine or non-benzodiazepine sleep medications for insomnia
• People who frequently wake during the night to urinate (nocturia)
• People whose doctor considers their mental health condition to be a safety concern for participation
• People who have had thoughts of suicide (with or without a plan), or suicidal behaviour, within the past 10 years
• People who have major surgery scheduled during the study period
• People who have travelled across more than 3 time zones in the 2 weeks before joining the study
• People who are allergic to the study drug (lemborexant) or any of its ingredients
• People who have previously taken part in a study involving lemborexant
• The final exclusion criterion appears incomplete in the source document — confirm any additional criteria directly with the trial site

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