A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

• Drug: PD 0200390
  
  oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
• Drug: PD 0200390
  
  oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
• Drug: PD 0200390
  
  oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
• Drug: PD 0200390
  
  oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
• Drug: PD 0200390
  
  oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
• Drug: Placebo
  
  oral placebo daily dose, 3 capsules per dose during a six week treatment period.

• Experimental: 15 mg
  
  Intervention: Drug: PD 0200390
• Experimental: 25 mg
  
  Intervention: Drug: PD 0200390
• Experimental: 35 mg
  
  Intervention: Drug: PD 0200390
• Experimental: 5 mg
  
  Intervention: Drug: PD 0200390
• Experimental: 50 mg
  
  Intervention: Drug: PD 0200390
• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo

Inclusion Criteria:

• Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
• Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos
• PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.

Exclusion Criteria:

• MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening
• BMI = or > 32 kg/m2
• History or presence of breathing related disorders
• PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.