Drug-related morning residual sleepiness. Insomnia
Conditions
Interventions
8 consecutive evenings at bedtime: lemborexant-matched placebo
2.5 mg, 5, mg,
or 10 mg lemborexant (before driving next morning)
2 evenings at bedtime, separated by 6 evenings: zopiclone-matched placebo
zopiclone 7.5 mg (before driving next morning).
Sponsors
Eisai
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy, male or female, aged 21 years or older at Screening 2. Regular time spent in bed between 7.0 and 8.5 hours per night as self-reported at the Screening visit and confirmed by the Sleep Diary completed during the Screening Period such that time spent in bed is within the stated duration range on at least 4 of the 7 nights where no more than 2 consecutive nights are out of range (revised per Amendment 03) 3. Regular bedtime, defined as the time the subject attempts to fall asleep, between 22:00 hours and 01:00 hours, and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 hours and 09:00 hours as self reported at the Screening visit and confirmed by the Sleep Diary completed during the Screening Period must be within the stated windows for bedtime and waketime on at least 4 of the 7 nights, where no more than 2 consecutive nights are out of the stated windows (revised per Amendment 03) 4. Body mass index (BMI) *18 and
Exclusion criteria
Exclusion criteria: - Females of childbearing potential who: * Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. * Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexually active during the study period or for 28 days after study drug discontinuation. * Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. * (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 [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]). - Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation. - Used any prohibited prescription or over-the-counter (OTC) concomitant medications within 1 week prior to starting the Sleep Diary during the Screening Period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SDLP will be analyzed using repeated-measures analyses of variance, separately for the 2nd and 9th day of each treatment period. The model will include fixed effects for age group, sequence, period, and treatment, and a random effect for subject within sequence. Where data are normally distributed, least squares (LS) means, difference in LS means of each lemborexant dose compared to placebo, 95% confidence interval (CI)s and P values will be presented and plotted. | — |
Secondary
| Measure | Time frame |
|---|---|
| Provided the data are distributed normally, the number of lapses will be analyzed similarly to the primary analysis for each lemborexant dose compared to placebo, separately for the 2nd and 9th day of each treatment period. SDLP and number of lapses will also be analyzed as above by age group, separately for the 2nd and 9th day of each treatment period. The frequency and percentage of outliers on SDLP, number of lapses, and prematurely stopped or never started driving tests will be summarized for each lemborexant dose and zopiclone, separately for the 2nd and 9th day of each treatment period. | — |
Countries
Netherlands
Outcome results
None listed