Flibanserin, sold under the brand name Addyi, is a medication prescribed to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. It is essential for individuals taking flibanserin to be well-informed about its potential side effects and interactions, as well as its possible impact on weight. This article aims to provide a comprehensive overview of these aspects, drawing on available research and clinical data.
Understanding Flibanserin and Its Use
Addyi (flibanserin) is commonly used to treat low sex drive (hypoactive sexual desire disorder or HSDD) in premenopausal women who have not had problems with low sexual desire in the past and have low sexual desire no matter the type of sexual activity or partner. It is not for people whose low sex drive is caused by medical or mental health problems, relationship problems, or medicines or drug use.
Flibanserin is believed to work by balancing brain chemicals that affect sex drive, such as dopamine, norepinephrine, and serotonin. The medication comes in 100 mg oral tablets and should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it.
Common Side Effects of Flibanserin
Like all medications, flibanserin can cause side effects. The most common side effects include:
- Dizziness
- Nausea
- Drowsiness or tiredness
- Trouble falling asleep or staying asleep
- Dry mouth
If any of these side effects bother you, it is important to tell your healthcare provider.
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Serious Side Effects and Precautions
While less common, flibanserin can cause serious side effects that require immediate medical attention:
- Severe Allergic Reactions: Symptoms include breathing problems or wheezing, racing heart, fever or general ill feeling, swollen lymph nodes, swelling of the face, lips, mouth, tongue, or throat, trouble swallowing or throat tightness, itching, skin rash, or pale red bumps on the skin called hives, nausea or vomiting, dizziness, feeling lightheaded, or fainting, stomach cramps, and joint pain.
- Central Nervous System (CNS) Depression: Symptoms include confusion, excessive sleepiness or trouble staying awake, memory problems, slow or shallow breathing, slowed response or reaction time, and slurred speech.
- Decreased Alertness or Coordination: Flibanserin can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination for at least six hours after taking Addyi and until you know how Addyi affects you.
- Low Blood Pressure (Hypotension) and Fainting: Symptoms include dizziness, feeling lightheaded, or fainting, blurred vision, confusion, and feeling weak or tired. If you feel faint or dizzy, lie down. The risk of low blood pressure or fainting can be increased if you drink alcohol or take certain medicines with Addyi.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Contraindications and Warnings
There are specific situations in which flibanserin should not be used:
- Allergies: People who are allergic to flibanserin or any of the ingredients in the specific product dispensed should not take Addyi.
- Drug Interactions: Addyi should not be taken while you are using certain other medicines.
- Liver Problems: Addyi should not be taken if your liver is not working as well as it should be.
Before using flibanserin, it is crucial to inform your healthcare provider about any current and past health conditions, including:
- A history of drug or alcohol misuse
- Low blood pressure
- Current or history of mental health problems, including depression
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
Interactions with Food, Drinks, and Other Medications
Flibanserin has several potential interactions that patients should be aware of:
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- Grapefruit: You should not eat or drink anything with grapefruit or grapefruit juice in it while taking Addyi. Grapefruit can increase blood levels of Addyi in your body and increase your risk of low blood pressure and fainting.
- Alcohol: It is best to avoid alcohol with Addyi. Alcohol can increase your risk of low blood pressure and fainting with Addyi. You should wait at least two hours after drinking two or fewer standard alcoholic drinks before taking Addyi at bedtime. If you have had three or more drinks with alcohol in them, you should skip your dose of Addyi that evening. Once you have taken Addyi in the evening, you should not drink any alcohol until at least the next day.
- Other Medicines: Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Do not use this medicine together with amprenavir, atazanavir (Reyataz®), boceprevir (Victrelis®), ciprofloxacin (Cipro®), clarithromycin (Biaxin®), conivaptan (Vaprisol®), diltiazem (Cardizem®), erythromycin (Ery-Tab®), fluconazole (Diflucan®), fosamprenavir (Lexiva®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone, nelfinavir (Viracept®), posaconazole (Noxafil®), ritonavir (Norvir®), saquinavir (Invirase®), telaprevir, telithromycin (Ketek®), or verapamil (Calan®). Using these medicines together may increase risk for low blood pressure and fainting.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using flibanserin.
Flibanserin and Weight Loss: What the Research Shows
A post hoc analysis of five studies has indicated that both premenopausal and postmenopausal women treated with flibanserin for HSDD are likely to experience weight loss. This analysis utilized data collected in the clinical development program for flibanserin in HSDD, with study conduct in compliance with the principles of the Declaration of Helsinki (1996) and in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines.
Study Details and Findings
The retrospective analysis included data from five studies from the flibanserin clinical development program in HSDD. Patients received double-blind flibanserin or placebo in the 24-week randomized controlled trials and open-label flibanserin in the 52-week extension study. The analysis population for the 24-week placebo-controlled trials consisted of patients who were randomly assigned to treatment, received at least one dose of study medication, and had at least one assessment of body weight.
In the pooled analysis of premenopausal women, mean baseline body mass index (BMI) was 27.0 kg/m2 in the flibanserin group (n = 1227) and 26.8 kg/m2 in the placebo group (n = 1238). In postmenopausal women, mean baseline BMI was 27.7 kg/m2 in the flibanserin group (n = 467) and 27.3 kg/m2 in the placebo group (n = 480).
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The key findings included:
- Weight Change: Among patients who completed 24 weeks of treatment, least squares (LS) mean weight change was −1.4 kg in the flibanserin group (n = 1010) and −0.1 kg in the placebo group (n = 1066; p < 0.0001) in premenopausal women. In postmenopausal women, LS mean weight change at week 24 was −1.8 kg in the flibanserin group (n = 385) and −0.1 kg in the placebo group (n = 425; p < 0.0001).
- Significant Weight Loss: Weight loss ≥5% from baseline was reported in 21.0% of patients who received flibanserin and 7.8% of patients who received placebo. Weight loss ≥10% was reported in 3.8% and 2.0% of patients, respectively.
- Comparable Weight Loss: Flibanserin-associated weight loss was comparable in both premenopausal and postmenopausal women. Also, there was no evidence of weight regain based on the assessment of patients treated with flibanserin for 18 months.
Potential Mechanisms for Weight Loss
The exact mechanism by which flibanserin produces weight loss is unknown. It has been suggested that it may affect body weight via a serotonin-based process or perhaps via a non-serotonin-related mechanism, such as enhanced cortical norepinephrine or dopamine release.
It is important to note that the patients with HSDD who participated in these clinical trials of flibanserin were not selected for overweight or obesity, nor did they enter the studies with the goal of losing weight. This makes the weight loss in the flibanserin-treated patients all the more intriguing.
Limitations of the Analysis
This analysis has several limitations. The studies included in this analysis were designed to evaluate the efficacy and safety of flibanserin for the treatment of women with HSDD. This analysis of change in body weight is, therefore, post hoc and exploratory in nature. There was no systematic attempt to collect information about the use of medications or supplements known to affect body weight or participation in programs intended to promote weight loss, nor was dietary or exercise counseling provided. Because this analysis included only observed cases, weight change was not assessed in patients who discontinued early from the underlying studies.
Considerations for Women Taking Flibanserin
If you are considering taking flibanserin or are currently taking it, keep the following points in mind:
- Regular Check-ups: It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
- Adherence to Instructions: Take flibanserin at bedtime, as prescribed by your healthcare provider.
- Awareness of Side Effects: Be aware of the potential side effects and report any concerning symptoms to your doctor immediately.
- Medication Interactions: Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
- Lifestyle Considerations: Abstain from grapefruit and limit or avoid alcohol consumption while taking flibanserin.
- Individual Response: Flibanserin doesn’t work for everybody. If your condition does not improve within 8 weeks, or if it becomes worse, check with your doctor.