| Eligibility |
Inclusion Criteria:
- Male and female Veterans, aged 18-64
- Determined to meet criteria for current posttraumatic stress disorder, as per the
Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) and a total score of =33 on
the PTSD Checklist (PCL-5)
- Meets DSM-5 standards of chronic insomnia disorder, as follows: a. Complains of
dissatisfaction with nighttime sleep in the form of difficulty falling asleep
(subjective sleep onset latency =30 minutes), difficulty staying asleep (subjective
time awake after sleep onset =30 minutes), and/or awakening earlier in the morning
(=30 minutes before scheduled wake time and before a total sleep time of 6.5 hours)
than desired. b. Insomnia frequency of =3 times per week c. The duration of the
insomnia complaint is =3 months d. Associated with complaint of daytime impairment
- Insomnia Severity Index total score =15 (moderate insomnia)
- Willing and able to comply with all aspects of the protocol
- Willing to not start a concurrent behavioral or other treatment program for insomnia,
PTSD, or other psychiatric disorders during the participation in the study
- If female subjects nor their partners are surgically sterile, and if they are not
post- menopausal (absence of menses for at least 12 months), female subjects are
considered to be of child-bearing potential. It is required that women of
child-bearing potential who are sexually active agree to either refrain from sexual
activity or use a two methods of contraception for the duration of the study (i.e.,
beginning 30 days prior to drug initiation and extending to 30 days after the last
dose of study drug). The two methods should include: 1) A barrier method (e.g., condom
with spermicidal gel, diaphragm with spermicide, intrauterine devices, cervical cap),
and 2) One other method, including hormonal contraceptives (e.g., oral contraceptives,
injectable contraceptives, contraceptive implant) or another barrier method.
Exclusion Criteria:
- Current or a history of a primary psychotic disorder (i.e., schizophrenia,
schizoaffective or bipolar disorder)
- Active suicidal or homicidal ideation requiring crisis intervention
- Current moderate or severe alcohol or marijuana/cannabis use disorder, or other
illicit use disorder of any severity
- A history of moderate or severe traumatic brain injury or other neurological illness
(i.e., stroke, epilepsy, multiple sclerosis)
- Caffeine use that is deemed excessive and is contributing to the insomnia per the
opinion of the investigators (i.e. caffeinated beverages consumed after 18:00 3
times/week or more and/or that correlates with the timing of the insomnia complaints)
- Tobacco use before bedtime that is contributing to the insomnia per the opinion of the
investigators or that would interfere with completing an overnight polysomnogram
- Previous diagnosis of periodic limb movement disorder, restless legs syndrome,
circadian rhythm sleep disorder, narcolepsy, RBD, or other sleep disorders (except
obstructive sleep apnea) that may confound, per the opinion of the investigators, the
assessment of insomnia
- Previous diagnosis of moderate to severe obstructive sleep apnea (defined as an AHI
equal to or greater than 15)
- Participants deemed to be at high risk of moderate to severe obstructive sleep apnea
per the Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age,
Neck circumference, and male Gender questionnaire (STOP-BANG). Subjects with a
STOP-BANG score of 5 or greater, or STOP score of 2 or greater plus (body mass index
greater than 35 kg/m2 or male or neck circumference greater than 40 cm), are
considered to be high-risk and will be referred to clinical treatment
- Participants identified as having moderate to severe obstructive sleep apnea during
the screening polysomnogram. These participants will be referred to clinical treatment
- Periodic limb movement arousal index 15 or greater or other sleep disorders captured
during the screening polysomnogram that may confound, per the opinion of the
investigators, the assessment and treatment of insomnia
- A prolonged QT interval, corrected for heart rate (QTc), at the screening
electrocardiogram. A prolonged QTc is defined as 470 milliseconds for males and 480
milliseconds for females
- Engagement in an evidence-based psychotherapy within 1-week prior to enrollment that
in the opinion of the investigators, may confound the assessment of insomnia (ex. CBT
for insomnia)
- Current evidence of clinically significant cardiac, respiratory, gastrointestinal,
renal, neurological, hepatic, and/or chronic pain that in the opinion of the
investigator(s) could affect the participant's safety or interfere with the study
assessments
- Females who are breastfeeding or pregnant at screening; 16. Females of childbearing
potential who are not practicing acceptable pregnancy prevention methods (NOTE: All
females will be considered to be of childbearing potential unless they are
postmenopausal or have been sterilized surgically)
- Patients with cardiac conditions that in the opinion of the investigators may increase
the risk of torsades de pointes and/or sudden death (ex. symptomatic bradycardia,
congenital prolongation of the QT interval)
- Current use of a prohibited medications: Hypnotic or sedating medications taken at
bedtime for insomnia; antipsychotics and antidepressants with known 5HT2A antagonist
activity; medications that increase or decrease the metabolism of pimavanserin;
medications that increase the risk of QTc prolongation
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