BACKGROUND AND PURPOSE:

• Self-reported sleep problems are common especially during the menopausal transition
• Guthrie et al. (Sleep, 2018) combined data from multiple studies to describe the efficacy of interventions on severe insomnia symptoms in women with menopause associated vasomotor symptoms (VMS)

METHODS:

• Pooling of data from 4 MsFLASH RCTs (Menopausal Strategies: Finding Lasting Answers to Symptoms and Health)
• Common eligibility criteria
  • 40–62 years
  • In the menopause transition, defined as amenorrhea ≥ 60 days in the past year OR postmenopausal, defined as ≥12 months since last menstrual period or bi-lateral oophorectomy) OR had a hysterectomy with one or both ovaries remaining and FSH >20 mIU/mL and estradiol ≤50 pg/mL
  • In good health based on history, physical exam and basic lab tests
  • Adjustments made for differences between studies
• Analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week
  • ISI assesses difficulty falling asleep | difficulty staying asleep |problems with early awakening, satisfaction with current sleep pattern | interference of sleep problem with daily functioning | noticeability of impairment attributed to the sleep problem | degree of distress caused by the sleep problem
    • Each item scored from 0-4
• Interventions included the following
  • escitalopram 10–20 mg/day
  • yoga
  • aerobic exercise
  • 8 g/day omega-3 fatty acids
  • oral 17-beta-estradiol 0.5-mg/day
  • venlafaxine XR 75-mg/day
  • cognitive behavioral therapy for insomnia (CBT-I), which includes
    • Stimulus control (e.g., not eating too close to bedtime)
    • Sleep hygiene (good sleep environment, e.g., removing distractions)
    • Sleep restriction (controlling time in bed and restoring the ‘bed-sleep’ connection rather than frustration of insomnia)
    • Relaxation training
    • Cognitive therapy (targeted sleep education)
• Outcome measures included ISI and Pittsburgh Sleep Quality Index (PSQI) over 8–12 weeks of treatment

RESULTS:

ISI

• CBT-I produced the greatest reduction from baseline relative to control at −5.2 points (95% CI −7.0 to −3.4)
• Effects similar for exercise at −2.1 and venlafaxine at −2.3 points
• Small decreases seen with escitalopram, yoga, and estradiol

PSQI

• The largest reduction from baseline was with CBT-I at −2.7 points (−3.9 to −1.5)
• Decreases were significant for escitalopram, exercise, yoga, estradiol, and venlafaxine
• Omega-3 supplements did not improve insomnia symptoms

CONCLUSION:

• Cognitive behavioral therapy for insomnia was the most effective treatment for menopause associated insomnia, followed by exercise and venlafaxine
• ACP recommends CBT-I as the initial treatment for chronic insomnia

Learn More – Primary Sources:

Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials

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