Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

Inclusion Criteria:

1. In the opinion of the treating physician, the patient is capable of understanding and
complying with protocol and program requirements, oral drug administration and care
instructions.

2. The patient or, when applicable, the patient's legally acceptable representative,
signs and dates a written, ICF and any required privacy authorization prior to the
initiation of any program procedures.

3. Men or women, 18 years of age and over.

4. Patients with a diagnosis of narcolepsy with or without cataplexy according to the
ICSD or DSM criteria at the time of diagnosis.

5. Patients should be free of prohibited treatments or have discontinued them for at
least 7 days prior to the start of treatments.

6. Women of child-bearing potential must have a negative serum pregnancy test performed
at the screening visit.

7. Due to the effectiveness of hormonal contraceptives potentially being reduced when
used with pitolisant, alternative or concomitant barrier methods of contraception are
required for patients taking hormonal contraceptives (e.g., ethinyl estradiol) when
taking pitolisant and for at least 21 days after discontinuation of pitolisant
treatment.

Exclusion Criteria:

1. The patient has severe hepatic impairment (Child-Pugh C).

2. The patient is a woman who is breastfeeding or plans to breastfeed during their
participation.

3. The patient has, in the judgment of the treating physician, a history or current
medical condition that could affect safety or poses an additional risk to the patient
by their participation in the program.

4. The patient is at high risk for suicide defined as a suicide attempt within the past
year, significant risk determined by the investigator interview, or use of the
Columbia Suicide Severity Rating Scale (C-SSRS).

5. The patient has a history of hypersensitivity or allergic reaction to pitolisant or
any inactive ingredient of the formulation.

6. Current or recent (within one year) history of a substance abuse or dependence
disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of
Mental Disorders (DSM-V).

7. Patients with a known history of long QTc syndrome (e.g. syncope or arrhythmia) or any
significant history of a serious abnormality of the ECG (e.g. recent myocardial
infarction), or QTc Fridericia higher than 450 ms for male and 470 ms for female
(electrocardiogram Fridericia's corrected QT interval = QT / 3√ RR).

8. Significant abnormality in the physical examination or clinical laboratory results.

9. Prior severe adverse reactions to CNS stimulants.