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

• Drug: Placebo
  
  Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
• Drug: PD 0200390
  
  Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
• Drug: PD 0200390
  
  Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
• Drug: PD 0200390
  
  Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.

• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo
• Experimental: PD 0200390, 5 mg
  
  Intervention: Drug: PD 0200390
• Experimental: PD 0200390, 15 mg
  
  Intervention: Drug: PD 0200390
• Experimental: PD 0200390, 30 mg
  
  Intervention: Drug: PD 0200390

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