Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

This is a multicenter, randomized, double blind, placebo controlled study of the safety and
efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of
generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8
weeks of treatment, and a 7 day follow-up period. This study was previously posted by
Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and
in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Inclusion Criteria:

- Male and female subjects must be between 18 and 50 years of age

- Subjects must have GAD

- Subjects must be in otherwise good general health

Exclusion Criteria:

- Subject has a documented history of HIV, hepatitis B or hepatitis C.

- Subject has a recent history (within 6 months of study entry) or current diagnosis of
Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past
month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or
other disorder.

- Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any
psychotic, bipolar or schizophrenic disorder.

- Subject has presence or history of antisocial personality or other severe disorder

- Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of
SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).

- Subject has history of seizures, including febrile seizures.

- Subject has initiated psychotherapeutic intervention with 30 days; however, continued
psychotherapy is allowed if stable and not specifically directed at GAD.

- Subject is undergoing or has undergone electroconvulsive therapy.

- Subject is a current smoker or has smoked within the last 12 months.

- Subject has donated blood within the past 30 days or plans to donate during and
within 30 days after study participation.