Investigator Studies Program (MISP): Insomnia

Effective February 2022, the Insomnia Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) up to March 9, 2022 for the first review cycle, up to May 19, 2022 for the second review cycle, up to August 18, 2022 for the third review cycle and up to November 17, 2022 for the fourth review cycle. This is a competitive process that will be conducted by the Insomnia MISP in 2022. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

The following areas are of interest to the Investigator Studies Program Committee:

• Human studies that differentiate suvorexant’s mechanism of action from other hypnotics.
• Studies investigating the optimal diagnosis and treatment of insomnia in subpopulations¹ and clinical settings² where orexin antagonism would be uniquely beneficial, or in circumstances where baseline orexin physiology is altered.
• Studies investigating the impact of insomnia and its treatment with suvorexant on patient outcomes (e.g. day-time function), healthcare utilization, caregiver burden, and healthcare costs.
• Studies relevant to suvorexant that characterize insomnia and sleep/wake outcomes through novel digital and data technologies (e.g. mobile devices, wearables, and remote sensing devices), inclusive of novel clinical trial endpoints relevant to sleep/wake biology.
• Nonclinical studies investigating sleep mechanisms related to orexins and insomnia, with a focus on translational functional measures.

¹Including but not limited to: Alzheimer’s disease, adult ADHD, circadian rhythm disorder, delirium, diabetes, epilepsy, fatigue, hypertension, major depressive disorder, migraine, multiple sclerosis, nocturia, oncology, panic disorder, Parkinson’s disease, perimenopausal disorders, PTSD, and shift work disorder.

²outpatient, inpatient, long-term care

Note: BELSOMRA® has been designated by the US DEA as a Schedule IV Controlled Substance. US Investigator initiated study sites and site personnel must provide proof of Federal Registration and State Licensure. All study sites must have standard operating procedures in place for compliance with all applicable controlled substance laws and regulations

Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US) or your MSD country representative (outside US). The protocols will be collectively reviewed and selected by the Insomnia MISP Committee.

Critical Activities and Timelines:

Activity	1stReview Cycle	2ndReview Cycle	3rdReview Cycle	4thReview Cycle
Protocol Submission / Detailed Budget	March 9, 2022	May 19, 2022	August 18, 2022	November 17, 2022

MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.