A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease
The purpose of this study is to see if the study drug, suvorexant, is safe and effective in treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of insomnia will participate in the study at this site
• Has signed and dated an Institutional Review Board-approved informed consent form before any protocol-specific screening procedures are performed;
• Has a diagnosis of Parkinson disease according to the United Kingdom Parkinson Disease Society Brain Bank Criteria;
• Has a modified Hoehn and Yahr Stage of 1-3, inclusive;
• Is aged 30-80 years old, inclusive;
• Has had no change in Parkinson's Disease medications during the 4 weeks preceding screening, with no dose changes during the study, except that as needed doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms;
• Is willing and able to complete polysomnogram;
• Is subject willing and able to limit alcohol use to 1 alcoholic drink per day during the study period and abstain from alcohol for 6 hours prior to each study-related polysomnogram?
• Is subject willing and able to abstain from caffeine and marijuana for 6 hours prior to and during each study-related polysomnogram
• Is subject willing and able to abstain from products containing nicotine during each study-related polysomnogram?
• Has Insomnia Disorder defined by diagnostic criteria published in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition; namely, subject report of all of the following:
‣ One of the following: difficulty initiating sleep; difficulty maintaining sleep; or early morning waking;
⁃ Sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning;
⁃ Sleep difficulty has occurred on 3 or more nights per week;
⁃ Sleep difficulty has been present for at least the past 3 months;
⁃ Sleep difficulty occurs despite adequate opportunity for sleep;
⁃ Insomnia is not explained by another sleep disorder;
⁃ Insomnia is not attributable to physiological effects of a consumed substance;
• On screening polysomnogram, has a latency to persistent sleep \> 20 minutes OR total wakefulness after sleep onset \> 45 minutes;
• May use other medications that could influence sleep, other than those specifically prohibited, as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study; and
• Has valid health insurance coverage at the time of study enrollment and expects this coverage to remain valid for the duration of the study period.