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

Inclusion Criteria

• Men or women of any ethnic origin
• Written informed consent is obtained
• Speaks and writes in English
• A willingness and ability to comply with study procedures.
• Age 25-75 years
• Diagnosis of Type 2 diabetes with suboptimally controlled blood sugar determined by HbA1c > 6.5% (and 10, indicating at least a moderate level of insomnia symptoms2
• Report a total sleep time ≤ 6.5 hours and combined sleep onset latency (SOL) and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. Combined SOL and WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit.

Exclusion Criteria

• Sleep and medical factors:
• 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)
• Shift workers
• Use of hypnotic medications more than twice per week in the past month
• Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
• Unwillingness to maintain stable diabetes medication during the study unless medically indicated
• Positive urine toxic screen for any drugs of abuse other than marijuana at Screening Visit
• HbA1c ≥ 10.0% at either the screening or randomization visit
• Psychiatric factors:
• Current major depressive episode, by report and as indicated by the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR).
• Subjects with active or unstable major psychiatric disorder, who, in the investigator's judgement, require further treatment.
• Current alcohol/substance use disorder
• Medical factors:
• Renal or hepatic disease judged to interfere with drug metabolism and excretion
• Pregnant or breastfeeding
• Malignancy within past 2 years
• Surgery within past 3 months
• 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
• Medical instability considered to interfere with study procedures
• Concomitant medications with drug interaction or co-administration concerns
• Contraindications or allergic responses to suvorexant
• History of being treated with suvorexant
• Lifestyle and other factors:
• Travel across two time-zones during the week prior to enrollment
• Greater than 6 cups of coffee per day