Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia

Exclusion Criteria

• •Current neurologic deficit (weakness, dysarthria or dysphagia, aphasia or dysphasia); Participants with a score of \<27 on Folstein MMSE will be excluded.
• •History of neurologic or psychiatric disease prior to TBI;
• •Epilepsy or history of seizure (whether related or unrelated to TBI);
• •Body mass index (BMI) ≥ 32;
• •Sleep apnea (Apnea Hypopnea Index, AHI \> 15/h); -Chronic sleep restriction (≥ 2hour sleep extension on weekends from self- report, diary, or at least 14 days of actigraphy);
• •Sleep-wake disturbance other than long sleep duration or sleepiness (DSPD, ASPD, Shift-work Sleep Disorder);
• •Diagnosis of narcolepsy or other sleep disorder prior to TBI;
• •Unwillingness to follow physician instructions relating to the concomitant use of alcohol and sodium oxybate during the study;
• •History of or current substance abuse;
• •Current regular CNS-affecting medication use;
• •History of depression, suicidal thoughts, and/or post-traumatic stress disorder (PTSD);
• •Current depression assessed by a structured clinical interview and Beck Depression Inventory (BDI);
• •Abnormal liver function (LFT more than twice the upper limit of normal or serum bilirubin more than 1.5 times the upper limit of normal);
• •Hypertension, heart failure, history of myocardial infarction, or abnormal EKG demonstrating clinically significant arrhythmia;
• •Kidney disease (Serum creatinine \>2.0mg/dl);
• •Lung disease (COPD, ILD, asthma);
• •On a low salt diet for medical reasons;
• •An occupation that requires variable shift work or routine night shifts (work hours between 11pm and 6am);
• •Pregnant, intention to become pregnant;
• •Breast-feeding or plans to breastfeed;
• •Succinic semialdehyde dehydrogenase deficiency.