A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)

A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia

The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.

This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.

Inclusion criteria:

1. Participants who submit written informed consent for study entry.

2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.

3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).

4. Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:

   • Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
   • Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

5. Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:

   • Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
   • Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

Exclusion criteria:

1. Participants with a present or history of the following disease specified in

   Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:

   • Risk of suicide
   • (Mild) manic episode
   • Post-traumatic stress disorder (PTSD)
   • Alcohol dependence and abuse
   • Drug (non-alcohol) dependence and abuse
   • Anorexia nervosa
   • Bulimia nervosa
   • Anti-social personality disorder

2. Participants with pharmacologically induced insomnia (drug-induced insomnia).

3. Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.

4. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.

5. Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.

6. Participants with organic mental disorder.