A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

Inclusion Criteria:

• Subject must understand the purpose of the study and be willing to adhere to the studyschedule and procedures described in this protocol.

• Subject must be 21 to 64 years of age (inclusive) on the day of signing consent.

• Subject must meet criteria for a primary and principal diagnosis of Major DepressiveDisorder.

• Subject's current depressive episode is at least 2 weeks but not longer than 6 monthsin duration.

• Subject must meet criteria for insomnia related to MDD and the symptoms of insomniamust not pre-date the symptoms of MDD by more than 10 weeks.

• Subject must report a sleep onset time of > 30 minutes, and wake time after sleeponset of > 45 minutes, and < 6.5 hours of total sleep time at least three times a weekover the previous month.

• Subject must take the Hamilton-D-17 scale and have a protocol pre-specified minimumscore.

• Subject must have no known clinically significant abnormal laboratory, ECG, orphysical examination findings at screening.

• Subject must meet one of the following conditions:

• Subject is not taking antidepressant medications at the time of study start.

• Subject is taking a sub-therapeutic dose of antidepressant or other disallowedpsychotropic medication and with the approval of the investigator agrees to taper offof this medication, prior to completion of screening assessments at study start.

Exclusion Criteria:

• Female subject is pregnant, lactating or within 6 months post partum.

• Subject has known sensitivity to any selective SSRI, zopiclone, or eszopiclone.

• Subject has history of major depressive disorder that was refractory to treatment withSSRIs.

• Subject has a current primary psychiatric diagnosis of any of the following disorders:dementia, delirium, schizophrenia, psychosis, other psychotic disorders, dysthymicdisorder; bipolar disorders; cyclothymic disorder, other mood disorders, nocturnalpanic disorder, primary anxiety disorders, primary panic disorders or any otherpsychiatric disorder that would compromise the investigator's ability to evaluate thesafety and efficacy of the study medication.

• Note: Subjects with Sexual and Gender Identity Disorders or other non-psychoticdisorders will be considered on a case-by-case basis. Subjects with MDD and asecondary diagnosis of generalized anxiety disorder, panic disorders other thannocturnal panic disorder or seasonal affective disorder will be allowed.

• Subject has any of the following Personality Disorders diagnoses: schizotypal,schizoid, borderline personality disorder; mental retardation or any other personalitydisorder that would compromise the investigator's ability to evaluate the safety andefficacy of the study medication.

• Subject has difficulties in sleep initiation or maintenance associated with knownmedical diagnosis [e.g. sleep apnea, restless leg syndrome (RLS), or periodic legmovement syndrome (PLMS)], or has any condition that has or may affect sleep [(e.g.,chronic pain, benign prostatic hypertrophy (BPH)].

• Subject has any clinically significant unstable medical or neurologic abnormality,unstable chronic disease, or a history of a clinically significant abnormality of thecardiovascular, respiratory, hepatic, or renal systems.

• Subject has a disorder or history of a condition (e.g., malabsorption,gastrointestinal surgery) that may interfere with drug absorption, distribution,metabolism, or excretion.

• Subject has a history of malignancy within 5 years, or current malignancy, except fornon-melanoma skin cancer.

• Subject has a history of drug or alcohol abuse or dependence in the past 6 months orpositive urine drug and alcohol test at screening.

• Subject is participating in, has participated in, or plans to participate in anyinvestigational drug study within 30 days prior to screening until the end of thisstudy.

• Subject has history of circadian rhythm disorder, or travels across >3 time zones on aregular basis.

• Subject is known to be seropositive for Human Immunodeficiency Virus (HIV).

• Subject has used any drugs known or suspected to affect hepatic or renal clearancecapacity within a period of 30 days prior to screening.

• Subject is unwilling to refrain from drinking alcoholic beverages during studyparticipation.

• Subject is a rotating or third/night shift worker.

• Subject is a staff member or relative of a staff member.