A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia

This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.

Inclusion Criteria:

• 3 month history of primary insomnia
• Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

Exclusion Criteria:

• Any history of psychiatric diagnosis
• History or presence of any breathing related sleep disorder
• History or presence of any medical or neurological condition that could interfere with sleep
• Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week