As a Certified Menopause Practitioner working daily with women navigating their menopausal transition, I know that complaints of fatigue go with the territory. And no wonder! If I were hot flashing day and night, sleeping poorly, feeling miserable with weight gain, mood swings, muscle aches, dry skin and palpitations, I suspect I would feel fatigued as well. Along with hot flashes, fatigue is one of the most prevalent menopausal symptoms and is strongly associated with reduced quality of life.
But what to do after the hormones are “balanced,” diet and exercise commitment improved, and sleep is better- and you are still fatigued!? As a clinician, I would then work you up to see whether something beyond the menopausal transition might be fatiguing you: this could include diabetes, hypothyroidism, occult malignancy or heart disease, anemia, Lyme disease, or an autoimmune phenomenon. If, this workup, which takes not more than 3 weeks, thankfully is entirely negative but you are still are not your productive, zippy self, what then? Depression is, of course, a possibility that not infrequently worsens during the menopausal transition, but which after evaluation appears unlikely.
What to do after you’re balanced, on all the right supplements, and remain fatigued? What to do if this path doesn’t work for you?
A new study, out of the Department of Psychiatry at Brigham and Women’s Hospital and Massachusetts General Hospital in Boston was published recently in the journal Menopause and caught my eye. Titled, “Armodafinil for fatigue associated with menopause: an open-label trial”, it studied the use and efficacy of the anti-narcolepsy drug Armodanafil (trade name in this country Nuvigil) for improving menopause-related fatigue and quality of life.
In the study protocol, 20 women (not a large number) aged 40-65 and who were experiencing menopause-related fatigue were given Armodafinil daily for 4 weeks after completing the Brief Fatigue Inventory and the Menopause-specific Quality of Life (“Q.O.L.”) questionnaires at baseline. Exploratory analyses examined the effects of armodafinil on hot flashes, overall quality of life, insomnia, depression, anxiety, and perceived cognitive performance. After treatment, participants were randomized to double-blinded continuation of Armodafinil vs. placebo for 2 weeks to see whether treatment discontinuation would precipitate symptom recurrence.
Brief Fatigue Inventory scores decreased by 58%, menopause-specific Q.O.L. improved 51%, hot flashes decreased 48%, cognitive function improved 59%, depressive symptoms diminished by 65%, insomnia was reduced by 78% and excessive sleepiness tested 57% less. All results were statistically significant at the p<.0001 to <.001 range.
Armodafinil is a medication which is FDA approved for the treatment of excessive sleepiness caused by narcolepsy or shift work sleep disorder, but has previously been evaluated for use in other fatigue conditions. While generally safe, there is the potential for some drug interactions, and the medication does not mix well with excessive alcohol or some street drugs. Several bothersome side effects have been noted. If seeking armodafinil, it is best to consult with a clinician savvy in its use and side-effect potential when treating for menopause-related fatigue.
In my practice, I presently do not utilize Armodafinil as a first-line agent, but only for continuing fatigue after hormonal “balancing,” or for women in whom the use of estrogen and/or testosterone is contraindicated. However, the study referenced above used it as a primary therapy when fatigue was not thought to be secondary to treatable conditions such as insomnia or mood disorder, but felt only to be temporally correlated with the menopause transition. This was the first study to investigate the effects of Armodafinil on fatigue and quality of life in perimenopausal and menopausal women experiencing menopausal-related fatigue.
This study provides preliminary evidence for another arrow in the menopause specialist’s quiver. Armodafinil may improve menopause related fatigue and Q.O.L. and other bothersome symptoms associated with menopause. A larger, blinded control study needs to be done, but at this point in time, evaluating possible benefits vs. side effects, I am beginning to utilize it for a select group of my patients. This is a work in progress!