Release Date: Monday, December 9, 2019
Expiration Date: Wednesday, December 9, 2020

Educational Overview
Sleep is increasingly being recognized as an important contributor to health. A growing body of evidence is supporting an association between poor sleep quality and duration with reduced quality of life as well as adverse cardiometabolic effects, including obesity, hypertension, type 2 diabetes, and cardiovascular disease. Appropriate management of sleep disorders can potentially improve management of chronic medical conditions, such as improved glycemic control in patients with type 2 diabetes mellitus. Though cognitive and behavioral therapy are commonly considered first-line treatments, the use of pharmacologic agents is needed in a large proportion of patients with sleep disorders. With the rapid decline in the number of sleep labs and certified sleep physicians over the past few years, diagnosis and management of sleep disorders is increasingly being relied upon by primary care providers (PCPs). However, PCPs may not be aware of the broad impact of poor sleep quality in their patients. This activity addresses these unmet needs in primary care in order to improve patient outcomes.

Target Audience
This continuing medical education activity meets the needs of primary care providers including internists, family physicians, doctors of osteopathy, physician assistants, and nurse practitioners, who can contribute to early detection and assessment of insomnia as well as participate in management of these patients.

Additional Resources and Updates
In December 2019, the US Food and Drug Administration approved lemborexant for the treatment of insomnia in adults. Lemborexant is the second orexin receptor antagonist approved for the treatment of insomnia in adults and is dosed at 5 mg or 10 mg PO immediately before going to bed. The approval was based on two pivotal phase 3 trials, SUNRISE 1 and SUNRISE 2.

SUNRISE 1:
Rosenberg R, Murphy P, Zammit G, et al. Comparison of lemborexant with placebo and zolpidem tartrate extended release for the treatment of older adults with insomnia disorder: a phase 3 randomized trial. JAMA Netw Open. 2019;2(12):e1918254. Available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2758000.

A randomized, double-blind, parallel-group, placebo-controlled, active comparator phase 3 trial comparing the efficacy and safety of lemborexant (5 or 10 mg), zolpidem tartrate ER (6.25 mg) or placebo in 1006 participants ≥55 years of age with insomnia disorder with a 1-month follow-up period.

Learning Objectives
At the conclusion of the educational activity, the learner should be able to:

• Describe the impact of insomnia on a patient’s quality of life and overall well-being
• Identify communication strategies aimed to improve the assessment of patient sleep quality to support earlier detection of potential sleep disorders
• Compare and contrast the benefits and risks of newer sleep medications, such as dual orexin receptor antagonists (DORAs), with traditional pharmacotherapeutic agents in the treatment of insomnia

Educational Format
This online presentation builds competence, confidence, and skills in the management insomnia while increasing the understanding of how to utilize patient-provider communication and latest therapeutic approaches to improve patient health outcomes. It is divided into 2 parts:

• Impact of Insomnia on Overall Health
• Pharmacologic Management of Insomnia
  “This enduring activity is based on the live program presented on Friday, November 15, 2019 at the GAFP Annual Scientific Assembly.”
  

Paul P. Doghramji, MD, FAAFP Medical Director Wellness Center Ursinus College Family Physician Collegeville Family Practice Collegeville, PA

SUNRISE 2:
Clinicaltrials.gov. Long-term study of lemborexant in insomnia disorder (SUNRISE 2). Available at: https://clinicaltrials.gov/ct2/show/results/NCT02952820.

A 12-month, multicenter, randomized controlled, double-blind, parallel-group phase 3 trial evaluating the efficacy and safety of lemborexant (5 mg or 10 mg) in 949 adults 18 to 88 years old with insomnia disorder. The study included a 6-month placebo-controlled treatment period and a 6-month period of only active treatment.