A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Eszopiclone 1 mg- Elderly; Eszopiclone 2 mg- Elderly; Eszopiclone 3 mg- Non-elderly; Eszopiclone 2 mg- Non-elderly
Intervention description: Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.; Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.; Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.; Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
Intervention MeSH terms: Eszopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 369.0
Sex: All
Minimum age: 20 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: insomnia; primary insomnia; insomnia associated with psychiatric or physical disorder(s)

Summary:

      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.
    

Eligibility criteria:

        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.