A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

• Drug: PD 0200390
  
  Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
• Drug: PD 0200390
  
  Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
• Drug: PD 0200390
  
  Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
• Drug: PD 0200390
  
  Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
• Drug: Placebo
  
  Matched oral placebo for weeks 2-7.

• Experimental: 15 mg PD 0200390
  
  Intervention: Drug: PD 0200390
• Experimental: 30 mg PD 0200390
  
  Intervention: Drug: PD 0200390
• Experimental: 45 mg PD 0200390
  
  Intervention: Drug: PD 0200390
• Experimental: 60 mg PD 0200390
  
  Intervention: Drug: PD 0200390
• Experimental: Placebo PD 0200390
  
  Intervention: Drug: Placebo

Inclusion Criteria:

• 3 month history of primary insomnia;
• 18 to 64 years
• For the last 3 months-regularly awake unrefreshed and unrestored
• 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 an Axis 1 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