Conditions: Insomnia
Keywords: insomnia primary insomnia insomnia associated with psychiatric or physical disorder(s)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 369
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Eszopiclone 1 mg- Elderly intervention 2: Eszopiclone 2 mg- Elderly intervention 3: Eszopiclone 3 mg- Non-elderly intervention 4: Eszopiclone 2 mg- Non-elderly
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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.

Protocol document: