To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia
Condition: Hypertension; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: suvorexant; Placebo
Intervention description: Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.; Placebo once daily before bedtime.
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effectiveness and safety of suvorexant versus
      placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

        [At interim registration]

        Patients who meet the following criteria are eligible for the study:

          1. Patients who give written consent of agreement to voluntarily participation in the
             clinical study

          2. Age 20 years or older

          3. Sex: Male or female

          4. Treatment classification: Outpatient

          5. Hypertensive patient who meet at least one of the following:

               -  Under antihypertensive medications

               -  Clinic systolic blood pressure (SBP) less than 160 mmHg

          6. Patients with insomnia who meet at least one of the following:

               -  Patients with any one of the following symptoms twice a week or more and at least
                  1 month-continuation: difficulty initiating sleep (time to sleep onset 2 hours or
                  more longer than usual), difficulty maintaining sleep (awakening twice or more in
                  the night), early morning awakening (awakening 2 hours or more earlier in the
                  morning than usual), difficulty sleeping deeply (no soundly asleep feeling at the
                  time of awakening in the morning).

                  b. Patients with interference with social or occupational function due to the
                  above insomnia symptoms

        [At official registration]

        Patients who meet the following criteria at the end of run-in period are eligible for the
        study:

          1. Stable unchanged antihypertensive medication for run-in period.

          2. Average morning home SBP more than 135 mmHg during 5 days before the end of run-in
             period.

        Exclusion Criteria:

          1. Patients with serious liver disease.

          2. Patients with serious respiratory disease.

          3. Patients with secondary hypertension

          4. Patients with sleep apnea syndrome

          5. Patients with history of narcolepsy or cataplexy

          6. Patients with history of organic cerebral disorders

          7. Patients with history of hypersensitivity to suvorexant

          8. Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and
             ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start
             of the run-in period

          9. Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period

         10. Patients received suvorexant and other hypnotic at the start of the run-in period on a
             regular basis

         11. Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become
             pregnant

         12. Patients who are considered not to be eligible for this study by their investigator or
             sub-investigator