The only nonhormonal FDA approved therapy for symptoms of menopause is a low-dose paroxetine mesylate capsule called Brisdelle. Brisdelle was approved by the FDA in 2013 to treat moderate to severe hot flashes associated with menopause.
Key Points About Brisdelle:
- Brisdelle contains paroxetine, which is a type of antidepressant in the class known as SSRIs (selective serotonin reuptake inhibitors). However, Brisdelle is specially formulated to contain a lower dose of paroxetine than what is used to treat depression.
- Even though it contains an antidepressant, Brisdelle is not approved to treat depression or any other psychiatric condition. It should only be used for menopausal hot flashes.
- Clinical trials showed that Brisdelle reduces the number of moderate to severe hot flashes by about 1-2 per day on average compared to placebo. This modest reduction can still provide relief for many women.
- Brisdelle has a low risk of drug interactions since it contains such a low dose of paroxetine. However, it should still be used cautiously with certain other drugs.
- Possible side effects of Brisdelle include headache, fatigue, nausea, and diarrhea. Most side effects are mild. Brisdelle is generally well tolerated.
- Treatment with Brisdelle showed a statistically significant reduction in the severity of hot flashes. Women reported fewer days with moderate to severe hot flashes compared to placebo.
Compared to
hormone therapy, Brisdelle offers a
nonhormonal alternative that may suit women who cannot or do not wish to take hormones. While not as fast-acting or robust as hormones,
Brisdelle provides a modest benefit that many women find valuable during the menopause transition.
Why Consider Nonhormonal Treatment?
There are several reasons why women may seek out a nonhormonal treatment option like Brisdelle:
- Hormone sensitivity - Some women experience unpleasant side effects when taking hormone therapy. Others develop health conditions like breast cancer that prevent hormone use.
- Osteoporosis - Brisdelle does not treat hot flashes by directly manipulating estrogen levels like hormones do. This makes it unlikely to accelerate bone loss.
- Health conditions - Certain conditions like history of blood clots or cardiovascular disease can exclude hormone therapy.
- Personal preference - Some women simply prefer to relieve hot flashes without adjusting their natural hormone levels if possible.
How Well Does Brisdelle Work?
In clinical studies funded by the drug manufacturer (Brisdelle is produced by Noven Therapeutics), Brisdelle performed significantly better than placebo at reducing hot flash severity and frequency:
- Women taking 7.5 mg Brisdelle for 12 weeks had around 1-2 fewer moderate-severe hot flashes per day compared to women taking placebo.
- For women taking Brisdelle, the average decrease in weekly hot flash frequency was 40%. This means if a woman had 15 hot flashes per week before starting the pills, she would average around 9 per week while taking Brisdelle.
- 50-60% of women treated with Brisdelle had at least a 50% decrease in moderate-severe hot flash frequency. Only around 40% of placebo-treated women experienced this level of improvement.
So while Brisdelle seems unlikely to eliminate hot flashes altogether, it can provide a meaningful reduction in frequency and severity for many women. The benefits start in as little as 1 week after starting on Brisdelle.
Brisdelle Dosage and Usage
- Brisdelle comes in capsules containing 7.5 mg paroxetine mesylate.
- The recommended dosage is one capsule per day, to be taken at bedtime.
- Taking Brisdelle with food can help reduce nausea. However, avoid taking it with grapefruit, grapefruit juice, or certain other citrus fruits which can disrupt appropriate breakdown of the medication.
- Most women in clinical trials took Brisdelle for 12 weeks. However, many experts suggest it can be used safely for 6 months or longer as needed to relieve hot flashes during menopause.
- If hot flashes persist bothersome after using Brisdelle for 2-3 months, the dose can potentially be safely increased to two capsules (15 mg) daily. Discuss this option with your healthcare provider.
- Like all SSRIs, Brisdelle should be tapered gradually rather than stopped abruptly. This minimizes the risk of side effects from withdrawal.
At Hormone Harmony Clinic, we provide cutting-edge care for all stages of hormone health for women. Whether you need expert guidance on managing menopause symptoms or want to take a proactive approach to hormonal wellness at any age, our compassionate providers offer personalized solutions to help you feel your best. Mention this article for 10% off your new patient exam!
