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Addyi (Flibanserin) for Low Libido: Benefits & Risks

Key Takeaways

  • Addyi (flibanserin) can help improve libido in women who have not yet undergone menopause. Clinical trials showed that treatment with Addyi results in approximately 0.5 to 1 additional satisfying sexual event per month compared to placebo. 

  • Common side effects include fatigue, nausea, dry mouth, sleep difficulties, and constipation. Addyi can also cause very low blood pressure, resulting in lightheadedness, dizziness, and fainting. 

  • Taking Addyi with hormonal birth control or antifungal therapy such as ketoconazole and fluconazole can lead to worsening side effects such as fatigue, dizziness, and sleepiness.   

Low sexual desire can affect your sexual performance and cause problems in your relationship with a sexual partner. An FDA-approved medication called flibanserin (brand name Addyi) can help premenopausal women who have low sexual desire. Please continue reading to find out more.

What is hypoactive sexual desire disorder (HSDD)?

Hypoactive sexual desire disorder (HSDD) is a type of female sexual dysfunction in which there is a persistent or recurrent lack of desire for sexual activity, resulting in marked psychological distress leading to potential difficulties in a relationship with a sexual partner. 

Experts estimate that HSDD affects approximately 8 to 10% of adult women in the US. Women with HSDD symptoms can develop depression, emotional distress, and other mental disorders as a result of low sexual desire or low libido. 

A diagnosis of hypoactive sexual desire disorder (HSDD) is made when there is a lack of motivation to initiate or participate in sexual activity, accompanied by significant personal distress causing a mental health problem such as depression, with the symptoms present for at least 6 months. 

Before prescribing Addyi, your doctor will make sure that your low sexual desire is not due to a medical or mental health problem, difficulties in your relationship, or a side effect of medications

Does Addyi help with libido?

Addyi (flibanserin) can help with libido in women with HSDD who have not yet undergone menopause (the change of life when monthly menstrual periods stop). This drug was made by Sprout Pharmaceuticals and received FDA approval in 2015 as the first drug to treat HSDD. Addyi is classified as a multimodal serotonergic agent; specifically, it acts as a serotonin receptor 1A agonist and serotonin receptor 2A antagonist and works by changing the levels of certain natural chemicals in the brain. It was originally developed as a treatment for mental illness (major depressive disorder). 

Can Addyi enhance sexual performance?

Addyi does not improve sexual performance. It is not a “female Viagra” or “pink pill.” This medicine affects brain chemicals that are responsible for low sexual desire. It helps to treat generalized HSDD (hypoactive sexual desire disorder) by balancing the levels of certain brain chemicals, but it does not have an effect on sexual function or sexual performance.

How to take flibanserin?

Flibanserin comes in the form of a tablet to take by mouth once a day at bedtime. You should try to take the medicine at around the same time every day. Read the prescription label carefully and take flibanserin (Addyi) exactly as prescribed. Do not change the dose or dosage frequency without talking with your doctor. Tell your doctor if you don’t notice any improvement in your symptoms after 8 weeks of taking flibanserin.

If you miss a dose of flibanserin, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose or extra medicine to make up for a missed dose. Avoid taking a dose during the daytime, as this can increase your risk of low blood pressure and fainting.

Store flibanserin and all medications safely out of reach of children and pets. Dispose of unneeded or expired medications through a drug take-back program. 

What are the negative effects of Addyi?

Common side effects of Addyi (flibanserin) include fatigue, nausea, dry mouth, sleep difficulties, and constipation. Tell your doctor if these side effects are severe or do not go away after a few days once your body has had a chance to get used to the medicine.

Sometimes, Addyi can cause more serious adverse effects, including an unusual or allergic reaction. Call your doctor immediately or seek emergency medical attention if you develop signs and symptoms of allergic reactions such as a skin rash, hives, itching, swelling of the face, lips, mouth, or throat, hoarseness, difficulty breathing or swallowing, or excessive sleepiness.

In case of an overdose, call your local poison control center or the national poison control center at 1-800-222-1222. Call 911 if someone has collapsed, stopped breathing, is unresponsive, or has had a seizure.

What are the risks of taking flibanserin for female sexual dysfunction?

Flibanserin can cause severe hypotension (very low blood pressure), resulting in lightheadedness, dizziness, and fainting. The risk of this happening is higher if you drink alcohol. Tell your doctor if you have or have ever had liver problems or if you have a history of excessive alcohol use. 

What to avoid while on Addyi?

Alcohol

Avoid drinking alcohol close to the time you take flibanserin, as this can increase your risk of developing very low blood pressure. If you have 1-2 standard alcoholic drinks, wait 2 hours or more before taking your flibanserin dose at bedtime. If you have 3 or more alcoholic beverages, skip your bedtime dose that day. After you have taken your flibanserin, do not drink alcohol until the next day. 

Grapefruit

Avoid eating grapefruit or drinking grapefruit juice while on flibanserin. Call your healthcare provider immediately if you feel dizzy, lightheaded, or faint. These side effects can put you at an increased risk of accidental injury.

Certain other medicines

Certain medicines can have possible drug interactions with flibanserin, causing therapies to be less effective or leading to severe adverse effects or health complications. Give your health care professional a complete list of your other medicines, including prescription drugs, over-the-counter medicines, dietary supplements, and herbal products. Flibanserin can interact with the following medications and should not be taken within 2 weeks of: 

If you are using Addyi, always consult with your doctor or pharmacist before starting a new medication, including prescription and over-the-counter products. Specifically, taking Addyi with medications with sedative effects can worsen drowsiness and sleepiness; examples include medicine for anxiety, sleeping pills, opioid pain medicines, muscle relaxers, and seizure therapy. 

What food and supplements should be avoided while taking Addyi?

Usually, Addyi reaches peak levels within 45 to 60 minutes of taking this medication. However, taking Addyi with a meal can delay peak levels by 1 to 3 hours. However, taking Addyi with a high-calorie, high-fat meal can significantly increase the blood levels of Addyi.   

Avoid grapefruit products while using Addyi to avoid unwanted side effects. 

You should always consult your healthcare provider before taking any over-the-counter (OTC) products or herbal supplements. Avoid taking the following OTC products can interact with Addyi:

Who should not take flibanserin for low sexual desire?

You should not take flibanserin (Addyi) if the following is applicable to you:

  • Being younger than 18 years of age

  • Male gender

  • Postmenopausal women

  • Having a medical condition that requires treatment with one of the medications listed above  

  • Having liver disease

  • Recently consumed alcohol; avoid taking Addyi within 2 hours of your last drink of alcohol 

Can you take Addyi on birth control?

Hormonal contraceptives can affect an enzyme called CYP3A4 (cytochrome P450 3A4). Specifically, hormonal contraceptives are weak inhibitors of the enzyme CYP3A4 which can lead to higher blood concentrations of flibanserin by approximately 40%. Taking Addyi with hormonal birth control can increase the risk of side effects such as fatigue, dizziness, and sleepiness. Notably, Addyi is used for the treatment of hypoactive sexual desire disorder in premenopausal women who are most likely to be on birth control pills or other forms of hormonal contraception

What is the success rate of Addyi?

A meta-analysis of clinical trials showed that treatment with Addyi results in approximately 0.5 to 1 additional satisfying sexual event per month. Compared to placebo, around 10% more of those treated with Addyi reported satisfying sexual events and a meaningful improvement in sexual desire.

Note: This medication guide is for information purposes only and should not be used as a substitute for a professional medical evaluation. Your healthcare provider can help you choose the best treatment for low sexual desire based on your symptoms, other medical conditions, and drug warnings.

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References:

  1. https://medlineplus.gov/druginfo/meds/a615040.html#

  2. https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394#:

  3. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394

  4. https://addyi.com/

  5. https://www.mayoclinic.org/drugs-supplements/flibanserin-oral-route/side-effects/drg-20152672?p=1

  6. https://nwhn.org/addyi-1-year-later/#

  7. https://pubmed.ncbi.nlm.nih.gov/26927498/

  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6198608/

  9. https://www.pharmacytimes.com/view/what-to-know-about-female-viagra-backed-by-fda-panel

  10. https://addyihcp.com/?gclid=Cj0KCQiA3uGqBhDdARIsAFeJ5r12MfnOdgLeibbMswnvWMZOj32mSOoC9Ju005Aob2DCAtCHlyfVw1kaAkw1EALw_wcB