If you are eligible for the study, and choose to participate, visits 1, 2 and 3 will be treatment visits in which you will receive the study drug and will stay overnight at one of our study sites for a study of your sleep patterns. The first visit will be a screening visit to a study site in your location, this is referred to as visit 0 and will be a day visit to discuss your eligibility for the study. Participants will be in this study for up to 7 weeks, and you will need to come to the study center at least 5 times over this period. This study will take place in approximately 50 centers in the United States with about 114 to 171 adults with narcolepsy. The Narcolepsy Research Study is evaluating an investigational drug (also known as the “study drug”) called SUVN-G3031 as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy, a sleep disorder that causes daytime drowsiness with or without muscle weakness. A doctor may also suggest other medications, like antidepressants, to help manage the condition. To treat narcolepsy, a doctor may prescribe stimulants to help keep you alert and awake throughout the day. Other symptoms of narcolepsy may include: 1 In between sleep attacks, however, patients with narcolepsy experience normal levels of alertness. 2 Excessive daytime sleepiness is characterized by persistent sleepiness, regardless of nighttime sleep accrual, and is often described as a “sleep attack” where patients experience a sudden and overwhelming sense of sleepiness. The main symptom of narcolepsy is excessive daytime sleepiness. People with narcolepsy are often misdiagnosed with other conditions, such as psychiatric disorders or medical disorders, delaying proper diagnosis and treatment for years. It is estimated that anywhere from 135,000 to 200,000 people in the United States (US) have narcolepsy. The disorder affects both males and females equally, with symptoms often starting in childhood, adolescence, or young adulthood (ages 7 to 25 years).
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Narcolepsy is a long-term neurological disorder that specifically affects the regulation of sleep-wake cycles.