Conditions: Chronic Insomnia
Keywords: chronic insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Detailed description:
Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

Arms:
arm 1: Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. arm 2: Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

Interventions: intervention 1: Placebo intervention 2: Ramelteon
Intervention descriptions: intervention 1: Placebo taken 30 minutes before bedtime days 1-28 of treatment period intervention 2: 8 mgs daily for days 1-28 of treatment period

Protocol document: