An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
Condition: Primary Insomnia; Secondary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: LY2624803; LY2624803; Placebo; zolpidem
Intervention description: 1 mg, oral capsule, once nightly before bedtime; 3 mg, oral capsule, once nightly before bedtime; matching placebo (capsule or tablet), once nightly before bedtime; 5 or 10 mg, oral tablet, once nightly before bedtime
Intervention MeSH terms: Zolpidem
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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