Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Inclusion Criteria:

• Obstructive sleep apnea
• Insomnia
• Age>60

Exclusion Criteria:

• Cognitive impairment
• Active alcohol or substance abuse
• Active use of other sedative-hypnotic agents
• Active use of fluvoxamine (drug interaction with Ramelteon
• Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel
• Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome
• Severe Chronic Obstructive Pulmonary Disease