Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women

Thirty-two peri- and postmenopausal women at the Boston sites (MGH and BWH) were enrolled
into this open-label pilot study. The study was a 7-week intervention study using open-label
gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by
300-mg for 3 weeks, and then 600-mg for 3 weeks. The intervention study followed a 3-week
screening period to establish a stable baseline for insomnia symptoms and VMS and to
determine the safety of administering gabapentin in study participants. Tolerability and
treatment response (insomnia symptoms, nighttime VMS) were assessed systematically at each
study visit. The dose titration schedule was followed in all participants unless there are
dose-limiting toxicities.

Inclusion Criteria:

1. Females aged 40-65 years

2. Postmenopausal or perimenopausal

3. Having bothersome hot flashes

4. Having some bothersome hot flashes during the night

5. Insomnia or problems sleeping

6. In general, good health

7. Signed informed consent

Exclusion Criteria:

1. Recent use of hormone therapy or hormonal contraceptives (with the exception of the
Mirena IUD)

2. Recent use of any prescribed therapy that is taken specifically for hot flashes

3. Recent use of any over-the-counter or herbal therapies that are taken specifically for
hot flashes

4. Recent use of any prescribed medications with known hot flash efficacy

5. Known hypersensitivity or contraindications (reasons not to take) to gabapentin

6. Not using a medically approved method of birth control, if sexually active and not 12
or more months since last menstrual period

7. Recent drug or alcohol abuse

8. Lifetime diagnosis of psychosis or bipolar disorder

9. Suicide attempt in the past 3 years or any current suicidal ideation

10. Current major depression (assessed during screening)

11. Pregnancy, intending pregnancy, or breast feeding

12. History of:

1. Renal insufficiency or a kidney disorder

2. Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb
movement disorder, or narcolepsy

13. Any unstable medical condition

14. Working a night/rotating shift

15. Abnormal screening blood tests

16. Current participation in another drug trial or intervention study

17. Inability or unwillingness to complete the study procedures