An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia

The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.

Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.

Inclusion Criteria:

• Patients must be between 18 and 85 years of age, with a stable living situation
• Clinical diagnosis of either primary insomnia or "secondary" insomnia (comorbid with depression, anxiety, and/or medical illness)
• Insomnia systems must be at least moderate in severity within the month prior to study entry, and must include difficulty staying asleep and/or problems with awakening earlier than desired
• Psychiatric and medical conditions present must be stable over the 3 months prior to study entry, and not expected to worsen significantly or require hospitalization during participation in the study
• Ongoing treatments for psychiatric and medical conditions present must have been stable for the 3 months prior to study entry, and must be expected to remain stable during participation in the study
• Patients must be willing to abstain from taking medications (other than study drug) to help them sleep during participation in the study
• Patients must be willing to consistently spend at least 7 hours each night either sleeping or trying to sleep during participation in the study
• Patients must be able to speak and read English and be capable of using a computer with a web browser (computers with internet connections will be provided to patients who need them)

Exclusion Criteria:

• Unusual or unstable sleep/wake schedule, such as with rotating shift work
• Severe or unstable psychiatric or medical illness
• Suicidal ideation
• Substance abuse
• Known obstructive sleep apnea, restless leg syndrome, or periodic limb movement disorder
• History of seizures
• Body Mass Index > 33
• Clinically significant abnormality in clinical chemistry, hematology, urinalysis, and/or electrocardiogram
• Anticipated inability to regularly use a medication which might reduce motor or cognitive functioning during sleeping hours, such as a person who might often need to be "on call", drive a car, or be responsible for the care of another person during sleeping hours
• Contraindication to zolpidem
• History of breast cancer
• An estimated glomerular filtration rate (GFR; an index of renal function) that is <30 mL/min at study entry