Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Inclusion Criteria:

   1. Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders,
   Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70),
   bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80),
   with concurrent insomnia related to bipolar disorder (307.42).

   2. Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents,
   anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for
   management of bipolar disorder.

   3. Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.

Exclusion Criteria:

   1. Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total
   score ≥ 12.

   2. Current (past 6 months) alcohol or substance use disorder.

   3. Current psychosis.

   4. Patients who are actively suicidal or evaluated as being a high suicide risk.

   5. Women who are currently pregnant or breastfeeding.

   6. Clinically significant abnormalities on baseline laboratory tests (comprehensive
   metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential,
   thyroid stimulating hormone).

   7. Presence of any unstable and/or potentially confounding neurological and/or medical
   disorder.