A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder
- Conditions
- insomnia disorder
- Registration Number
- JPRN-jRCT2080223414
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Both doses of lemborexant demonstrated statistically significant improvement from Baseline compared to PBO for both sleep onset and sleep maintenance variables after 6 months of treatment. Statistically significant improvement from Baseline were also demonstrated for sSOL, sSE, and sWASO after 7 nights and at Month 3, and for sSOL and sSE also at Month 1 for both doses of lemborexant compared to placebo. Lemborexant was safe and well tolerated without clinically significant findings at LEM5 and LEM10.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 971
(1)Male or female, age 18 years or older at the time of informed consent
(2)Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder, as follows:
Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep, and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
Frequency of complaint >=3 times per week
Duration of complaint >=3 months
Associated with complaint of daytime impairment
(3)History of subjective sleep onset latency (sSOL) >=30 minutes on at least 3 nights per week in the previous 4 weeks AND subjective wake after sleep onset (sWASO) >=60 minutes on at least 3 nights per week in the previous 4 weeks
(4)Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
(5)Reports regular bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 09:00
(6)Insomnia Severity Index (ISI) score >=15
(7)Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary
(8)Confirmation of regular bedtime and waketime, as determined from responses on the Sleep Diary
(9)Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
(10)Willing to not start a behavioral or other treatment program for insomnia during the study
(1)A current diagnosis of sleep-related breathing disorder, 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
(2)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
(3)On the Munich Parasomnia Scale (MUPS), (a) a history of symptoms of Rapid Eye Movement (REM) Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating; or (b) symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
(4)For participants who underwent polysomnography (PSG) the previous year:
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
(5)Beck Depression Inventory - II (BDI II) score >19 at Screening
(6)Beck Anxiety Inventory (BAI) score >15 at Screening
(7)Habitually naps more than 3 times per week
(8)Females who are breastfeeding or pregnant at Screening or Study Baseline
(9)Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.)
(10)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
(11)History of drug or alcohol dependency or abuse within approximately the previous 2 years
(12)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
(13)Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological [including participants who lack capacity and/or whose cognitive decline indicates disorientation to person/place/time and/or situation], or psychiatric disease or malignancy other than 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
(14)Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
(15)Used any prohibited prescription or over-the-counter concomitant medications within 1 week before the first dose of study medication
(16)Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 2 weeks before Screening
(17)Failed treatment with suvorexant (Belsomra) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
(18)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
(19)Previously participated in any clinical t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Mean change in Subjective Sleep Onset Latency (sSOL) [ Time Frame: Beginning of placebo-controlled treatment; 6 months of placebo-controlled treatment ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method other<br>-