A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

Inclusion Criteria:

- Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic
treatment for the condition

- Usual nightly total sleep at least 6 hours as single major rest period without naps

- Epworth Sleepiness Scale of 10 or greater

- Males or females age 18 to 65 years

Exclusion Criteria:

- Any disorder causing hypersomnia other than IH or Narcolepsy Type 2

- Usual bedtime later than midnight

- Seizure disorder or history of syncope, unexplained loss of consciousness or seizure
in the past 3 years

- Beck Depression Inventory score greater than 19

- Beck Anxiety Inventory score greater than 15

- Significant history of or current suicidal ideation or behavior

- BMI less than 18 kg/m2 or greater than 39 kg/m2

- Positive toxicology screen or breathalyzer test

- Clinically significant abnormal findings on safety assessments

- Any significant medical or psychiatric disease or any condition that would put the
patient at risk by participating in the study