Efficacy Study of LY2422347 to Treat Insomnia

• Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
• improvement of daily subjective sleep quality at endpoint
• reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
• Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
• increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
• Clinician Global Impression of Improvement (CGI-I) score at endpoint
• improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
• Safety and tolerability of LY2422347 compared with placebo

• - Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
• -improvement of daily subjective sleep quality at endpoint
• -reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
• -Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
• -increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
• -Clinician Global Impression of Improvement (CGI-I) score at endpoint
• -improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
• -Safety and tolerability of LY2422347 compared with placebo

The purpose of this study is to determine whether a compound known as LY2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).

• Drug: LY2422347
• Drug: placebo

Inclusion Criteria:

• must have been diagnosed with primary insomnia
• must not be significantly overweight
• must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day
• must be able to read and speak in English and be able to see well enough to use the handheld electronic device
• the patient's answer to the question "During the past month, how would you rate your sleep quality overall?" must be either "Very Bad" or "Fairly Bad"

Exclusion Criteria:

• cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD)
• cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination
• cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep
• cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.