WARNING

Flibanserin, also known as Addyi, is a medication used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. However, like any medication, it carries certain risks:

• Low blood pressure (hypotension): Flibanserin can cause a drop in blood pressure, especially when taken with alcohol or certain other medications. This can lead to dizziness, fainting, or even loss of consciousness.
• Central nervous system depression: Combining flibanserin with alcohol or other central nervous system depressants can increase the risk of drowsiness, impaired judgment, and coordination problems.
• Interaction with other medications: Flibanserin can interact with certain medications, particularly those that affect liver enzymes. This can lead to increased levels of flibanserin in the body, potentially causing adverse effects.
• Side effects: Common side effects of flibanserin include dizziness, nausea, fatigue, insomnia, and dry mouth. These side effects can be bothersome and may affect the medication’s tolerability.
• Safety concerns: Flibanserin has been associated with concerns regarding its efficacy and safety profile. Some studies have questioned its effectiveness in increasing sexual desire, while others have raised concerns about its long-term safety.
• FDA warnings: The U.S. Food and Drug Administration (FDA) has issued warnings about the risks associated with flibanserin, particularly its potential for causing severe hypotension and central nervous system depression, especially when taken with alcohol.
• Limited availability: Flibanserin is not widely available and requires a prescription. Additionally, due to its risks and limited efficacy for some individuals, it may not be suitable for all patients with HSDD.

It’s essential for individuals considering taking flibanserin to discuss the potential risks and benefits with their healthcare provider and to carefully follow their provider’s recommendations and guidance.

Why is this medication prescribed?

Flibanserin is prescribed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by a persistent lack of sexual desire that causes distress or interpersonal difficulty.

How should this medicine be used?

As for how flibanserin should be used:

• Dosage: Flibanserin comes as a tablet to take by mouth. The typical starting dose of flibanserin is 100 milligrams (mg) once daily at bedtime.
• Consistency: Flibanserin should be taken every night, regardless of sexual activity.
• Timing: It’s important to take flibanserin at bedtime to minimize the risk of side effects such as dizziness, which can occur when standing up after taking the medication.
• Alcohol avoidance: Patients should avoid alcohol while taking flibanserin, as alcohol can increase the risk of side effects such as low blood pressure and dizziness.
• Regular follow-up: Patients should have regular follow-up appointments with their healthcare provider to monitor the effectiveness and safety of flibanserin and to adjust the dosage if necessary.
• Duration of treatment: The duration of treatment with flibanserin should be determined by the healthcare provider based on the individual’s response to the medication and the presence of any side effects.
• Patient education: Patients should be educated about the potential side effects of flibanserin and instructed to seek medical attention if they experience severe or persistent symptoms.

It’s essential for individuals prescribed flibanserin to follow their healthcare provider’s instructions carefully and to discuss any questions or concerns they may have about the medication. Additionally, individuals should inform their healthcare provider about any other medications they are taking to avoid potential interactions.

Other uses for this medicine

Flibanserin is primarily prescribed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women and does not have other approved uses. However, there may be ongoing research into potential alternative uses for the medication.

What special precautions should I follow?

As for special precautions to follow when taking flibanserin:

• Avoid alcohol: It’s crucial to avoid alcohol while taking flibanserin. Alcohol can increase the risk of side effects such as low blood pressure, dizziness, and fainting.
• Inform your healthcare provider: Before starting flibanserin, inform your healthcare provider about any other medications you are taking, including prescription drugs, over-the-counter medications, vitamins, and supplements. Flibanserin can interact with certain medications, particularly those that affect liver enzymes.
• Follow dosing instructions: Take flibanserin exactly as prescribed by your healthcare provider. The typical starting dose is 100 milligrams (mg) once daily at bedtime.
• Take it consistently: Flibanserin should be taken every night, regardless of sexual activity. It’s important to establish a routine and take the medication at the same time each day.
• Be aware of side effects: Be aware of potential side effects of flibanserin, including dizziness, nausea, fatigue, insomnia, and dry mouth. If you experience severe or persistent side effects, contact your healthcare provider.
• Regular follow-up: Attend regular follow-up appointments with your healthcare provider to monitor the effectiveness and safety of flibanserin and to discuss any concerns or questions you may have.
• Pregnancy and breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of taking flibanserin with your healthcare provider. The safety of flibanserin during pregnancy and breastfeeding has not been established.
• Medical conditions: Inform your healthcare provider if you have any medical conditions, especially liver problems or a history of depression or suicidal thoughts. Flibanserin may not be suitable for individuals with certain medical conditions.

Following these precautions can help ensure the safe and effective use of flibanserin. It’s essential to discuss any questions or concerns with your healthcare provider before starting the medication.

What special dietary instructions should I follow?

As for special dietary instructions, there are no specific dietary restrictions associated with taking Flibanserin. However, it’s generally recommended to maintain a balanced diet and avoid excessive alcohol consumption, as mentioned earlier.

What should I do if I forget a dose?

If you forget to take a dose of Flibanserin, take it as soon as you remember, unless it’s almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you’re unsure about what to do, consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Flibanserin, like any medication, can cause side effects. Some common side effects associated with Flibanserin include:

• Dizziness: Feeling lightheaded or dizzy is a common side effect of Flibanserin, especially when standing up from a sitting or lying position.
• Nausea: Some individuals may experience feelings of nausea or an upset stomach while taking Flibanserin.
• Fatigue: Feeling tired or fatigued is another common side effect reported by some individuals taking Flibanserin.
• Insomnia: Difficulty falling or staying asleep may occur in some people taking Flibanserin.
• Dry mouth: Flibanserin may cause a dry sensation in the mouth, leading to discomfort.

These side effects are typically mild to moderate in severity and may diminish over time as the body adjusts to the medication. However, if any of these side effects persist or worsen, it’s important to inform your healthcare provider.

In addition to these common side effects, Flibanserin can also cause more serious side effects in some individuals. These can include:

• Hypotension (low blood pressure): Flibanserin can cause a drop in blood pressure, leading to symptoms such as dizziness, fainting, or feeling lightheaded.
• Central nervous system depression: Combining Flibanserin with alcohol or certain other medications that depress the central nervous system can increase the risk of drowsiness, impaired judgment, and coordination problems.
• Syncope (fainting): Some individuals may experience fainting episodes while taking Flibanserin, particularly if they stand up too quickly after lying down or sitting.
• Interaction with other medications: Flibanserin can interact with certain medications, particularly those that affect liver enzymes. This can lead to increased levels of Flibanserin in the body, potentially causing adverse effects.

It’s important to discuss any concerns or questions about side effects with your healthcare provider before starting Flibanserin. If you experience severe or persistent side effects while taking Flibanserin, contact your healthcare provider promptly.

What should I know about storage and disposal of this medication?

Storage and Disposal of Flibanserin:

Storage:

• Store Flibanserin at room temperature away from light and moisture.
• Keep it out of reach of children and pets.
• Do not store Flibanserin in the bathroom or near the kitchen sink where it may be exposed to moisture or heat.

Disposal:

• Dispose of unused or expired Flibanserin properly according to local regulations or guidelines.
• Do not flush Flibanserin down the toilet or pour it down the drain unless instructed to do so.
• Consult your healthcare provider or pharmacist for guidance on how to safely dispose of Flibanserin.

In case of emergency/overdose

In case of emergency or overdose of Flibanserin:

• If you suspect an overdose of Flibanserin, seek emergency medical attention or contact a poison control center immediately.
• Symptoms of overdose may include severe dizziness, fainting, vomiting, or difficulty breathing.
• Be prepared to provide information about the amount of Flibanserin taken, as well as any other medications or substances ingested.

What other information should I know?

• Keep all appointments with your healthcare provider for regular follow-up and monitoring while taking Flibanserin.
• Inform all healthcare providers involved in your care that you are taking Flibanserin, including dentists and specialists.
• Avoid activities that require alertness and coordination, such as driving or operating machinery, until you know how Flibanserin affects you.
• Do not change the dose or stop taking Flibanserin without consulting your healthcare provider.
• Report any new or worsening symptoms, including mood changes or thoughts of self-harm, to your healthcare provider immediately.
• Carry a list of all medications you are taking, including Flibanserin, and show it to any healthcare provider who treats you.

Following these guidelines can help ensure the safe and effective use of Flibanserin while minimizing the risk of adverse effects or complications.