Combination hormone/nonhormone & Off-Label Drugs

There  is growing interest in finding non-hormonal drugs for menopause symptoms.   This may include new drugs, new formulas of drugs  or off-label use of an existing drug. Off label drug use means prescribing a drug for a condition for which it has not officially received FDA approval. 

Listed below are several off-label drugs that are currently being  used to treat menopause symptoms.

  • Antidepressants—prescription antidepressants  may be able to help with the menopausal symptoms of mood swings, hot flashes, depression and irritability. Selective serotonin reuptake inhibitors (SSRIs) recommended include venlafaxine, paroxetine, escitalopram and fluoxetine.
  • Gabapentin—An anticonvulsant drug used to control seizures and may also lower the number of hot flashes each day and the intensity of the hot flashes. How it works is not fully understood.
  • Clonidine—a blood pressure medication available in pill or patch form that reduces the pressure of blood flow through the artery. Clonidine may relieve or reduce hot flashes for some women
  • Researchers are also the use of nerve-blocking injections into the neck as an alternative treatment for severe hot flashes that shows promise.

Below are new drugs FDA-approved for menopause symptom relief that may or may not have some hormones:

  • Brisdelle (Paraxetine) is a drug used to treat depression, anxiety and other mood disorders but the dose prescribed for hot flash relief is lower.  While it does not contain estrogen, women with breast cancer or women on tamoxifen should not take it. There is a also increased risk for blood clots and bleeding.
  • Duavee (conjugated estrogen with bazedoxifene) has been approved for prevention of osteoporosis and moderate to severe hot flashes.  While it contains an estrogen, the added bazedoxifene is a selective estrogen receptor modulator (SERM) that provides an alternative to progestin to protect the endometrial lining and help protect the bones. While not hormone free, it does remove the need to take progesterone. There are some drug interactions including one with grapefruit juice and it should not be used by women with a history or risk of blood clots.
  • Osphene (ospemifene) is a SERM that is approved to help with vaginal atrophy and painful sex.  It has an estrogen effect on the vaginal and vulvar tissue.  However, it can also have an estrogen effect on the endometrium  so women should discuss if a progestin is still needed if she has her uterus. It can increase hot flashes.