Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

Exclusion Criteria

• •1. Sleep and medical factors:
• •1. Diagnosis of severe obstructive sleep apnea not using CPAP (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy, moderate to severe restless legs syndrome)
• •2. Shift workers
• •3. Use of hypnotic medications more than twice per week in the past month
• •4. Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
• •5. Unwillingness to maintain stable diabetes medication during the study unless medically indicated
• •6. Positive urine toxic screen for any drugs of abuse other than marijuana at Screening Visit
• •7. HbA1c ≥ 10.0% at either the screening or randomization visit
• •2. Psychiatric factors:
• •1. Current major depressive episode, by report and as indicated by the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR).
• •2. Subjects with active or unstable major psychiatric disorder, who, in the investigator's judgement, require further treatment.
• •3. Current alcohol/substance use disorder
• •3. Medical factors:
• •1. Renal or hepatic disease judged to interfere with drug metabolism and excretion
• •2. Pregnant or breastfeeding
• •3. Malignancy within past 2 years
• •4. Surgery within past 3 months
• •5. Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment
• •6. Medical instability considered to interfere with study procedures
• •7. Concomitant medications with drug interaction or co-administration concerns
• •8. Contraindications or allergic responses to suvorexant
• •9. History of being treated with suvorexant
• •4. Lifestyle and other factors:
• •1. Travel across two time-zones during the week prior to enrollment
• •2. Greater than 6 cups of coffee per day