Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance inPosttraumatic Stress
Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.
• Men and Women, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide written informed consent
• Criterion A event meets DSM-5 criteria
• PTSD symptoms \>3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening
• Insomnia indicated by an ISI score \> 14
• Subjects on non-exclusionary medications must be on a stable dose for at least 4 weeks prior to randomization, which includes the Selective Serotonin Reuptake Inhibitors (SSRIs) e.g.:
‣ Sertraline
⁃ Paroxetine
⁃ Fluoxetine
⁃ Fluvoxamine
⁃ Citalopram
⁃ Escitalopram
• Serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g.:
‣ Desvenlafaxine
⁃ Duloxetine
⁃ Levomilnacipran
⁃ Venlafaxine
• For subjects who are in psychotherapy, treatment must be stable for 6 weeks
• Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control, e.g.:
‣ oral
⁃ implantable
⁃ injectable
⁃ transdermal contraceptive
⁃ intrauterine device
⁃ double-barrier method
• Sleep apnea score \<30; if screening indicates mild or moderate sleep apnea (score between 5 and 30), referral will be provided