<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03008447</url>
  </required_header>
  <id_info>
    <org_study_id>E2006-A001-108</org_study_id>
    <nct_id>NCT03008447</nct_id>
  </id_info>
  <brief_title>Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled and Active Comparator, 4 Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Purdue Pharma LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change&#xD;
      from baseline in postural stability (worsening) when participants are awakened at&#xD;
      approximately 4 hours postdose is significantly less after lemborexant than after zolpidem&#xD;
      tartrate extended release following a single-dose administration at bedtime.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2016</start_date>
  <completion_date type="Actual">January 3, 2018</completion_date>
  <primary_completion_date type="Actual">January 3, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
    <description>Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to ZOL and placebo (PBO) at approximately 8 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to PBO at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline in auditory awakening threshold (AAT) for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose</measure>
    <time_frame>approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any serious adverse event and number of participants with any non-serious adverse event</measure>
    <time_frame>up to 72 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>LEM5; LEM10; PBO; ZOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive LEM5 (one lemborexant [LEM] 5 milligram [mg] tablet and one zolpidem [ZOL]-matched placebo [PBO] tablet) in Treatment Period 1. In Treatment Period 2, participants will receive LEM10 (one LEM 10 mg tablet and one ZOL-matched PBO tablet). In Treatment Period 3, participants will receive PBO (one LEM-matched PBO tablet and one ZOL-matched PBO tablet). In Treatment Period 4, participants will receive ZOL (one LEM-matched PBO tablet and one ZOL 6.25 mg tablet).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LEM10; ZOL; LEM5; PBO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive LEM10, ZOL, LEM5, and PBO in Treatments Periods 1, 2, 3, and 4, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZOL; PBO; LEM10; LEM5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive ZOL, PBO, LEM10, and LEM5 in Treatment Periods 1, 2, 3, and 4, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBO; LEM5; ZOL; LEM10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive PBO, LEM5, ZOL, and LEM10 in Treatment Periods 1, 2, 3, and 4, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEM5</intervention_name>
    <description>Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.</description>
    <arm_group_label>LEM10; ZOL; LEM5; PBO</arm_group_label>
    <arm_group_label>LEM5; LEM10; PBO; ZOL</arm_group_label>
    <arm_group_label>PBO; LEM5; ZOL; LEM10</arm_group_label>
    <arm_group_label>ZOL; PBO; LEM10; LEM5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEM10</intervention_name>
    <description>Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.</description>
    <arm_group_label>LEM10; ZOL; LEM5; PBO</arm_group_label>
    <arm_group_label>LEM5; LEM10; PBO; ZOL</arm_group_label>
    <arm_group_label>PBO; LEM5; ZOL; LEM10</arm_group_label>
    <arm_group_label>ZOL; PBO; LEM10; LEM5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZOL</intervention_name>
    <description>Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.</description>
    <arm_group_label>LEM10; ZOL; LEM5; PBO</arm_group_label>
    <arm_group_label>LEM5; LEM10; PBO; ZOL</arm_group_label>
    <arm_group_label>PBO; LEM5; ZOL; LEM10</arm_group_label>
    <arm_group_label>ZOL; PBO; LEM10; LEM5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBO</intervention_name>
    <description>Single dose of placebo administered within 5 minutes before bedtime.</description>
    <arm_group_label>LEM10; ZOL; LEM5; PBO</arm_group_label>
    <arm_group_label>LEM5; LEM10; PBO; ZOL</arm_group_label>
    <arm_group_label>PBO; LEM5; ZOL; LEM10</arm_group_label>
    <arm_group_label>ZOL; PBO; LEM10; LEM5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, non-smoking female participants, aged 55 years and older, or male&#xD;
             participants, aged 65 years and older, at the time of informed consent&#xD;
&#xD;
          -  Regular sleep timing and duration, per the following criteria:&#xD;
&#xD;
               1. Regular time in bed, between 7 and 9 hours as reported at Screening and verified&#xD;
                  by the Sleep Diary during the Screening Period before the adaptation night such&#xD;
                  that time in bed is not less than 7 hours or more than 9 hours on more than 2 of&#xD;
                  the 7 consecutive nights recorded in the Sleep Diary&#xD;
&#xD;
               2. Regular bedtime, defined as the time the participant attempts to fall asleep,&#xD;
                  between 22:00 and 01:00 and regular waketime, defined as the time the participant&#xD;
                  gets out of bed for the day, between 05:00 and 09:00 as reported at Screening and&#xD;
                  verified by the Sleep Diary during the Screening Period before the adaptation&#xD;
                  night such that neither bedtime nor waketime is outside of the permitted time&#xD;
                  windows on more than 2 of the 7 consecutive nights&#xD;
&#xD;
          -  Able to detect a 1000 Hertz (Hz) tone at 20 decibels (dB)&#xD;
&#xD;
          -  Able to read English at an 8th-grade level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is a female of childbearing potential Note: All females will be considered to be of&#xD;
             childbearing potential unless they are postmenopausal (defined as amenorrheic for at&#xD;
             least 12 consecutive months, and are postmenopausal without other known or suspected&#xD;
             cause), or have been sterilized surgically (i.e., bilateral tubal ligation, total&#xD;
             hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before&#xD;
             dosing).&#xD;
&#xD;
          -  A current diagnosis of insomnia disorder, sleep-related breathing disorder, periodic&#xD;
             limb movements disorder (PLMD), restless legs syndrome, circadian rhythm sleep&#xD;
             disorder, narcolepsy, sleep-related violent behavior, sleep-driving, sleep-eating, or&#xD;
             symptoms of another parasomnia that in the investigator's opinion make the participant&#xD;
             unsuitable for the study&#xD;
&#xD;
          -  Has subjective sleep onset latency (sSOL) &gt; 20 minutes or subjective wake after sleep&#xD;
             onset (sWASO) &gt; 60 minutes on more than 2 nights as reported on the Sleep Diary during&#xD;
             the Screening Period before the adaptation night&#xD;
&#xD;
          -  Latency to persistent sleep (LPS) longer than 30 minutes as measured on the PSG on the&#xD;
             Baseline night (or repeat Baseline night, if needed)&#xD;
&#xD;
          -  Has a sleep onset Rapid eye movement (REM) period, defined as first epoch of stage REM&#xD;
             within 15 minutes of sleep onset, as measured on the PSG on either the adaptation&#xD;
             night or Baseline night (or repeat Baseline night, if needed)&#xD;
&#xD;
          -  Apnea-Hypopnea Index &gt; 15 or Periodic Limb Movement with Arousal Index &gt; 15 as&#xD;
             measured on the PSG on the adaptation night&#xD;
&#xD;
          -  Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom&#xD;
             during the night&#xD;
&#xD;
          -  History of fracture due to a fall within the past 5 years&#xD;
&#xD;
          -  Evidence of orthostatic hypotension at Screening&#xD;
&#xD;
          -  Use of hearing aid or clinically significant hearing loss&#xD;
&#xD;
          -  Presence or history of Meniere's disease, labyrinthitis, benign paroxysmal positional&#xD;
             vertigo, no recent vertigo from any other cause, no recent dizziness or head injury&#xD;
&#xD;
          -  Unable to stand unaided for a minimum of 2 minutes&#xD;
&#xD;
          -  At Screening, fails Romberg test in the clinical judgment of the investigator&#xD;
&#xD;
          -  Significant vision loss or inability to read computer screen in &lt;80 lumens per square&#xD;
             meter (lux) ambient illumination&#xD;
&#xD;
          -  History of drug or alcohol dependency or abuse within approximately the previous 2&#xD;
             years or have a positive urine drug screen at Screening or Baseline&#xD;
&#xD;
          -  Self-reports consuming more than 14 alcohol-containing drinks per week (females) or 21&#xD;
             alcohol containing drinks per week (males) at Screening&#xD;
&#xD;
          -  A prolonged QT/heart rate corrected QT interval (QTc) (QT interval corrected for&#xD;
             Fridericia's formula [QTcF] &gt; 450 milliseconds [ms]) as demonstrated by a repeated&#xD;
             electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF&#xD;
             interval &gt; 450 ms)&#xD;
&#xD;
          -  Any suicidal ideation at Screening or within 6 months of Screening or any lifetime&#xD;
             suicidal behavior&#xD;
&#xD;
          -  Evidence of clinically significant disease (e.g., cardiac, respiratory,&#xD;
             gastrointestinal, renal, psychiatric or neurological disease, malignancy other than&#xD;
             basal cell carcinoma, or chronic pain) or condition that in the opinion of the&#xD;
             investigator(s) could affect the participant's safety or interfere with the study&#xD;
             assessments&#xD;
&#xD;
          -  Used any prohibited prescription or over-the-counter concomitant medications within 1&#xD;
             week or 5 half lives, whichever is longer, before the Baseline night&#xD;
&#xD;
          -  Scheduled for surgery during the study&#xD;
&#xD;
          -  Transmeridian travel across more than 3 time zones in the 2 weeks before the first&#xD;
             Baseline night, or plans to travel more than 3 time zones during the study.&#xD;
&#xD;
          -  Currently enrolled in another clinical trial or used any investigational drug or&#xD;
             device within 28 days or 5 half lives, whichever is longer preceding informed consent&#xD;
&#xD;
          -  Hypersensitivity to lemborexant or zolpidem or any of their excipients&#xD;
&#xD;
          -  Active viral hepatitis (B or C) as demonstrated by positive serology&#xD;
&#xD;
          -  Previous exposure to lemborexant or suvorexant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NeuroTrials Research, Inc</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinilabs, Inc</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Assoicates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research Management Associates d/b/a CTI Clinical Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>E2006</keyword>
  <keyword>postural stability</keyword>
  <keyword>auditory awakening threshold</keyword>
  <keyword>cognitive performance</keyword>
  <keyword>healthy participants</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03008447
org study id: E2006-A001-108
nct id: NCT03008447
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change
      from baseline in postural stability (worsening) when participants are awakened at
      approximately 4 hours postdose is significantly less after lemborexant than after zolpidem
      tartrate extended release following a single-dose administration at bedtime.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
description: Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo.
measure: Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to ZOL and placebo (PBO) at approximately 8 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to PBO at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline in auditory awakening threshold (AAT) for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
measure: Number of participants with any serious adverse event and number of participants with any non-serious adverse event
time frame: up to 72 days
arm group label: LEM5; LEM10; PBO; ZOL
arm group type: Experimental
description: Participants will receive LEM5 (one lemborexant [LEM] 5 milligram [mg] tablet and one zolpidem [ZOL]-matched placebo [PBO] tablet) in Treatment Period 1. In Treatment Period 2, participants will receive LEM10 (one LEM 10 mg tablet and one ZOL-matched PBO tablet). In Treatment Period 3, participants will receive PBO (one LEM-matched PBO tablet and one ZOL-matched PBO tablet). In Treatment Period 4, participants will receive ZOL (one LEM-matched PBO tablet and one ZOL 6.25 mg tablet).
arm group label: LEM10; ZOL; LEM5; PBO
arm group type: Experimental
description: Participants will receive LEM10, ZOL, LEM5, and PBO in Treatments Periods 1, 2, 3, and 4, respectively.
arm group label: ZOL; PBO; LEM10; LEM5
arm group type: Experimental
description: Participants will receive ZOL, PBO, LEM10, and LEM5 in Treatment Periods 1, 2, 3, and 4, respectively.
arm group label: PBO; LEM5; ZOL; LEM10
arm group type: Experimental
description: Participants will receive PBO, LEM5, ZOL, and LEM10 in Treatment Periods 1, 2, 3, and 4, respectively.
intervention type: Drug
intervention name: LEM5
description: Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.
arm group label: LEM10; ZOL; LEM5; PBO
arm group label: LEM5; LEM10; PBO; ZOL
arm group label: PBO; LEM5; ZOL; LEM10
arm group label: ZOL; PBO; LEM10; LEM5
intervention type: Drug
intervention name: LEM10
description: Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.
arm group label: LEM10; ZOL; LEM5; PBO
arm group label: LEM5; LEM10; PBO; ZOL
arm group label: PBO; LEM5; ZOL; LEM10
arm group label: ZOL; PBO; LEM10; LEM5
intervention type: Drug
intervention name: ZOL
description: Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.
arm group label: LEM10; ZOL; LEM5; PBO
arm group label: LEM5; LEM10; PBO; ZOL
arm group label: PBO; LEM5; ZOL; LEM10
arm group label: ZOL; PBO; LEM10; LEM5
intervention type: Drug
intervention name: PBO
description: Single dose of placebo administered within 5 minutes before bedtime.
arm group label: LEM10; ZOL; LEM5; PBO
arm group label: LEM5; LEM10; PBO; ZOL
arm group label: PBO; LEM5; ZOL; LEM10
arm group label: ZOL; PBO; LEM10; LEM5
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor