Investigator Studies Program (MISP): Insomnia

Effective December 2022, the Insomnia Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) - please see submission deadlines below. This is a competitive process that will be conducted by the Insomnia MISP in 2023. 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:

• Studies investigating the optimal diagnosis and treatment of insomnia with suvorexant in patients who reside in long-term care settings.
• Studies investigating the impact of treating insomnia with suvorexant on patient outcomes, healthcare utilization, caregiver burden and healthcare costs in patients with dementia, mild cognitive impairment, or risk factors for cognitive impairment.
• Studies investigating populations where orexin antagonism would be uniquely beneficial, or baseline orexin physiology is altered.

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 Deadline	February 13, 2023	April 1, 2023	July 1, 2023	September 1, 2023

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.