PITOLISANT TAB
Clinical Criteria Summary
Exclusion Criteria
- Excessive daytime sleepiness associated with OSA not receiving primary therapy (e.g., CPAP)
- Severe hepatic impairment (e.g., Child-Pugh C)
- Known hypersensitivity to pitolisant
- Receiving a drug known to prolong the QT interval
- End-stage renal disease (e.g., eGFR < 15 ml/min)
- Patient with known QT prolongation
- Symptomatic bradycardia
- Hypokalemia
- Hypomagnesemia
- Receiving a centrally acting histamine-1 receptor antagonist
Inclusion Criteria
- Treatment of excessive daytime sleepiness (EDS) OR cataplexy associated with narcolepsy
- Epworth Sleepiness Scale (EES) is > 14
- Documented lack of efficacy with, is intolerant of, or has contraindications to modafinil OR armodafinil
- Prescribed and monitored by a VA/VA Community Care sleep specialist / pulmonologist / neurologist or locally designated expert in sleep disorders