The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.
Participants aged 20-65 will be recruited for a study exploring the relationship between sleep and low field magnetic stimulation (LFMS), a novel and safe form of brain neurostimulation. Recruitment will be accomplished by posting advertisements on the MUSC broadcast messages and online media (e.g. craigslist). Those responding to the advertisements will undergo a brief phone screening where basic information about the study will be discussed, and to ensure that all inclusion and exclusion criteria are met. Those individuals who are both interested and meet criteria will meet with one of the investigators for an enrollment visit, during which time they will review and sign an informed consent document. If they continue to meet inclusion and exclusion criteria they will spend two nights in the sleep lab, separated by 4-10 days. On both occasions they will undergo an overnight sleep study and receive LFMS while they sleep.
Participants will be recruited and screened through ongoing studies in the sleep and anxiety disorders clinic. Participants with insomnia will be consented to complete several questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study. Each of the two treatment conditions (active versus sham) will be conducted on two consecutive nights. There will be no more than 7 days between the adaptation night and the first treatment condition and no more than 7 nights between each of the two-night treatment conditions . Thus, each participant who completes the full study will spend a total of 5 nights in the sleep laboratory and the time interval from the first adaptation night to completion of the study may range from 5-19 days for any particular individual.
The Sleep Research Data Repository (SRDR) aimed to systematically collect, analyze and store for future research sleep and sleep disorders related biological and psychological information. It will include sleep physiological measurements and the results of interviews, questionnaires, and laboratory tests. The SRDR will contain sleep related information obtained from healthy subjects and patients with psychiatric, substance abuse, neurological disorders, or any medical conditions associated with sleep disturbances. SRDR data will be made available to current and future IRB-approved investigators associated with this protocol.