A Study of Lemborexant in Chinese Participants With Insomnia Disorder

Exclusion Criteria

• •Participants who meet any of the following criteria will be excluded from this study:
• •1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
• •2. Females of childbearing potential who: Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
• •* total abstinence (if it is their preferred and usual lifestyle)
• •* an intrauterine device or intrauterine hormone-releasing system
• •* a contraceptive implant
• •* an oral contraceptive (participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation)
• •* have a vasectomized partner with confirmed azoospermia
• •* do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
• •3. Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
• •4. A prolonged corrected QT interval by Fredericia's formula (QTcF) interval (QTcF \>450 millisecond \[ms\]) as demonstrated by a repeated electrocardiogram. A history of risk factors for torsade de pointes (for example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval
• •5. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening
• •6. Any suicidal behavior in the past 10 years
• •7. Evidence of clinically significant disease (for example, cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal; moderate and severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded
• •8. Hypersensitivity to lemborexant or to their excipients
• •9. Scheduled for surgery during the study
• •10. Known to be human immunodeficiency virus positive
• •11. Active viral hepatitis (B or C) as demonstrated by positive serology
• •12. History of drug or alcohol dependency or abuse within approximately the last 2 years
• •13. A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows:
• •* Snoring, Tiredness, Observed apnea, high blood Pressure (STOP)-Body mass index (BMI), Age, Neck circumference, and Gender (BANG) score \>=5
• •* International Restless Legs Scale score \>=16
• •14. Apnea-hypopnea Index \>15 or Periodic Limb Movement with Arousal Index \>15 as measured on the PSG at the second Screening Visit
• •15. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
• •16. Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior (for example, making phone calls or preparing and eating food while sleeping)
• •17. For participants who underwent diagnostic PSG within 1 year before informed consent:
• •* Age 18 to 64 years: Apnea Hypopnea Index \>=10, or Periodic Limb Movements with Arousal Index \>=10
• •* Age \>=65 years: Apnea Hypopnea Index \>15, or Periodic Limb Movements with Arousal Index \>15
• •18. Beck Depression Inventory-II score \>19 at Screening
• •19. Beck Anxiety Inventory score \>15 at Screening
• •20. Habitually naps during the day more than 3 times per week
• •21. Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study. Participants are excluded if, in the previous 3 months, they had symptoms that would meet DSM-5 criteria for caffeine intoxication, which includes consumption of a high dose of caffeine (significantly in excess of 250 mg) and \>=5 of the following symptoms: restlessness, nervousness, excitement, insomnia, flushed face, diuresis, gastrointestinal disturbance, muscle twitching, rambling flow of thought and speech, tachycardia or cardiac arrhythmia, periods of high energy, or psychomotor agitation. To be exclusionary, those symptoms must cause distress or impairment in social, occupational and other forms of functioning, and not be associated with other substance, mental disorder or medical condition
• •22. Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study
• •23. Excluding comorbid nocturia that is causing or exacerbating the insomnia
• •24. Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half-lives, whichever is longer, before the first dose of study medication (Run-in Period)
• •25. Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half-lives, whichever is longer, before the first dose of study medication (Run-in Period)
• •26. Failed treatment with dual orexin receptor antagonist drugs (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
• •27. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel across more than 3 time zones during the study (China mainland will be considered as 1 time zone)
• •28. A positive drug test at Screening, Run-in, or Baseline, or unwilling to refrain from use of recreational drugs during the study
• •29. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5 half-lives, whichever is longer preceding informed consent
• •30. Previously participated in any clinical trial of lemborexant