The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women

This is an interventional treatment trial for Menopause focused on measuring Menopause, Insomnia, Depression, Anxiety, Sleep, Lunesta, Quality of Life Read More

Inclusion Criteria:

1. Women 40+ years old.

2. Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW):

   1. Early Menopausal Transition (Stage -2): Variable cycle length >7 days different from normal.
   2. Late Menopausal Transition (Stage -1) : > 2 skipped cycles and an interval of amenorrhea > 60 days.
   3. Post Menopause (Stage +1): Amenorrhea for at least 12 months.
   4. Surgical Post Menopause
   5. Hysterectomized women with one or both ovaries preserved will be eligible if FSH levels > 20 IU/L.
   6. If on hormonal therapy, history of menstrual-cycle abnormalities consistent with any of 2a-2e above indicating peri-/postmenopausal status prior to initiation of hormonal therapy.

3. One or both the following insomnia symptoms for ³ 3 nights per week for at least one month prior to study enrollment:

   1. Difficulty initiating sleep (³ 30 minutes)
   2. Difficulty maintaining sleep (wake time after sleep onset ³ 30 minutes)
4. Daytime function or well-being is impaired as a result of insomnia.

5. Mild depression and/or anxiety at screening visit defined as:

   1. Mild Depressive symptoms defined by Montgomery-Åsberg Depression Rating Scale-MADRS (MADRS) ³ 10 administered at screening visit, or
   2. Mild Anxiety symptoms defined by Beck Anxiety Inventory (BAI) ³ 10 administered at screening visit.
6. May have (but not required) hot flushes
7. May have (but not required) developed insomnia after discontinuation of hormonal therapy.
8. If subject is on an antidepressant, they must have stable doses for at least 2 months.
9. If subject is on hormonal therapy, dose must be stable for at least 2 months.
10. General Good Health

Exclusion Criteria:

1. According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past criteria for past 3 months:

   1. Major Depression
   2. Dysthymia
   3. Panic disorder
   4. PTSD (Post-Traumatic Stress Disorder)
2. According to M.I.N.I, subject has no evidence of current suicidal ideation, homicidal ideation, or psychotic symptoms at screening visit.
3. Suicide attempt in the past 5 years.
4. According to M.I.N.I, subject meets criteria for substance use disorder diagnosis within the past 5 years.
5. Subject has current or recent use (in the past month and used > 25% of time) of hypnotic agents.
6. Subject is on an antidepressant or hormone therapy in past 2 months. (Unless they are taking currently and have had a stable dose for ≥ 2 months).

7. Subject has:

   1. Unstable medical abnormality
   2. Unstable chronic disease.
8. History of significant cardiac, renal, or hepatic disease, or seizure disorder.
9. Regular use of any disallowed medication (Including; Clarithromycin, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Olanzapine, Rifampin, Ritonavir, Troleandomycin) currently or in the past month.
10. Subject has a disorder or history of a condition (e.g., mal-absorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
11. Subject has a been previously diagnosed sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.).
12. Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day during the past month.
13. Currently pregnant or breastfeeding
14. Subject is a rotating or third/night shift worker.
15. Subject often travels across multiple time zones.
16. Subject is currently enrolled in another clinical trial, subject has participated in any investigational drug study within 30 days prior to screening, or plans to participate in another investigational drug study during participation in this study.