A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

Exclusion Criteria

• •Use of potential multiple sclerosis-associated fatigue drugs within 3 days of screening until study completion, including modafinil, armodafinil, amantadine, methylphenidate, products with amphetamine or dextroamphetamine;
• •Use of any of any prohibited medication (including Digoxin, benzodiazepines, barbiturates, opiates, Zolpidem, Zaleplon, Eszopiclone, moderate or strong CYP3A inhibitors, or strong inducers of CYP3A) from 3 days prior to screening to termination visit;
• •Female who is breast-feeding, pregnant, or has the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures);
• •History of narcolepsy;
• •Has a diagnosis of severe chronic obstructive pulmonary disease (COPD), defined by forced expiratory volume 1 (FEV1) \< 50% of predicted on most recent available pulmonary function test (PFT). Pulmonary function test is not required if the subject has never been diagnosed with chronic obstructive pulmonary disease;
• •Has a history of severe obstructive sleep apnea (OSA), with severe obstructive sleep apnea defined as having an apnea-hypopnea index (AHI) \> 30 on prior polysomnograph (PSG). Polysomnograph is not required if there is no history of obstructive sleep apnea;
• •Is concurrently using other central nervous system (CNS) depressants, including alcohol, except that one alcoholic drink per day will be allowed for those with normal hepatic function provided the drink is consumed at least 2 hours prior to or 8 hours after taking the study drug. Medical marijuana is allowed if consumed at the patient's usual dose at least 2 hours prior to or 8 hours after taking the study drug. Recreational marijuana is not allowed from screening until end of study;
• •Has evidence at screening of severe hepatic impairment as defined by a Child-Pugh score \> 10;
• •Cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent;
• •Suicidality or severe depression as measured by screening Beck Depression Inventory II (BDI) score \> 28 or score of \>1 on Beck Depression Inventory II Question 9 (suicidality screen) at any time during the study;
• •Any other serious and/or unstable medical condition.