A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia

Inclusion Criteria:

1. Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been
present for at least a 4-week period.

2. Subject has a diagnosis of Insomnia that is confirmed at screening based on the DSM-5
diagnostic criteria using the SCID-5-CT, with insomnia symptoms that must not have
predated the symptoms of MDD by more than 10 weeks.

3. Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).

4. Subject has a MADRS score of ≥28 prior to dosing

Exclusion Criteria:

1. Subject has attempted suicide associated within the current episode of MDD.

2. Subject had onset of the current depressive episode during pregnancy or 4 weeks
postpartum, or the subject has presented for screening during the 6-month postpartum
period.

3. Subject has a medical history of bipolar disorder, schizophrenia, and/or
schizoaffective disorder.

4. Subject has a medical history of seizures.

5. Subject has active psychosis per Investigator assessment.