This checklist should be used only as a guide. For the complete list of inclusion and exclusion criteria, please refer to the ClinicalTrials.gov. Any questions, please call us at 726-444-5230.
Have you been diagnosed with narcolepsy?
If you have been diagnosed with narcolepsy, are you currently taking 6-9 g of a high-sodium oxybate (like XYREM) nightly.
If you are on a stable dose of high-sodium oxybate (like XYREM) for at least 6 consecutive weeks.
On average what is your systolic blood pressure number (i.e. if your blood pressure is 120 over 80, the systolic number is 120 mm Hg)
On average what is your diastolic number (i.e. if your blood pressure is 120 over 80, the diastolic number is 80 mm Hg).
lf you are taking antihypertensive (blood pressure) medication, have you been on a stable dose over the past month?
lf you are taking stimulants or other medications that affect blood pressure, have you been taking a stable dose for at least 2 months prior to study.
Do you have a history of or are currently experiencing an acutely unstable medical condition, behavioral or psychiatric disorder, or surgical history?
Have you had or do you have any significant cardiovascular disease including but not limited to:Atrial fibrillationUnstable angina pectorisCongestive heart failureArrhythmias requiring automatic implantable cardioverter defibrillator or anti-arrhythmic therapyOr within the past year have a:Myocardial infarctionRevascularization procedure
Have you had a substance use disorder (Excluding caffeine. Nicotine use disorder only if it disrupts sleep)
Do you have a known diagnosis of:Phenylketonuria, Hypersensitivity to phenylalanine-derived products, or Succinic semi-aldehyde dehydrogenase deficiency
Are you employed in an occupation that requires nighttime (starting work at night and working into morning) or variable shift work.