The specific aims of the proposed study are to compare the sleep, daytime functioning, and circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans alone and in combination with multi-component behavior therapy (MCBT) in patients with chronic insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Placebo pill nightly for 42 nights.
Rozerem 8mg pill, nightly for 42 nights
Rozerem 8mg pill nightly for 42 nights with 4 sessions and 2 telephone calls of Multi Component Behavior Therapy.
University of Arizona Sleep Research Laboratory
Tucson, Arizona, United States
Sleep Onset Latency
Daily assessment of sleep and daytime functioning (daily voice mail sleep diary and actigraphy) for 10 weeks: 2 weeks prior to and after treatment and during the 6 week treatment period. The primary sleep outcomes will be improvement in sleep onset latency (SOL) and total sleep time (TST).
Time frame: Baseline, Post treatment, 3 month follow up
Dim Light Melatonin Onset
Assessment of circadian melatonin phase 2 weeks prior to and 2 weeks after treatment(dim light melatonin onset-DLMO, 2 weeks prior to treatment and 2 weeks post treatment assessment of quality of life (SF-36) and sleep quality (Pittsburgh Sleep Quality Index-PSQI), 2 weeks prior to treatment and 2 weeks post treatmemnt daily assessment of daytime functioning.
Time frame: Baseline, post treatment
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