Flibanserin Oral Tablets - An Overview

Introduction

Hypoactive sexual desire disorder (HSDD) is a condition characterized by a persistent absence of sexual desire and fantasies, causing interpersonal difficulties or distress. It is especially known to affect women with depression or negative emotions. The individual's complete medical and psychiatric history is required to recognize the causes or contributing factors to address the condition. It is seen in around ten percent of women in the United States. However, the prevalence rates of the condition vary, and HSDD is considered one of the most common female sexual difficulties. Hypoactive sexual desire disorder can be managed in the majority of people by counseling or sex therapy and medications such as Flibaserin.

What Are Flibanserin Oral Tablets?

Flibanserin oral tablets are indicated in premenopausal women for the management of hypoactive sexual desire disorder. It was approved in 2015 by the United States Food and Drug Administration (FDA) and is the first drug to be approved for acquired and generalized HSDD (patients who have not had any previous problems with sexual desire). Flibanserin acts on the neurotransmitters (specific serotonin receptors) or chemicals in the brain that are responsible for sexual excitement. It is available in 100 mg (milligram) tablets and must be taken orally once daily at bedtime. Flibanserin oral tablets must be taken exactly as prescribed, and if a dose is missed, it must be taken the next day at bedtime; a double dose must not be taken. Flibanserin must not be used if HSDD is due to medical or psychiatric disorders, relationship problems, or side effects of certain medications.

How Effective Are Flibanserin Oral Tablets?

The American College of Obstetricians and Gynecologists (ACOG) and the American Psychiatric Association (APA) support the use of Flibanserin oral tablets in premenopausal women with HSDD and also acknowledge it as a viable treatment option for the condition. Flibanserin was initially developed to treat depression. However, positive results in sexual function were observed during research, and hence, it is considered a pivotal choice for females with primary HSDD. Several clinical studies have been conducted to determine the efficacy of Flibanserin. It included participants around 36 years of age and with a known case of HSDD for five years. The results determined by the questionnaire showed statistical significance suggesting an improvement in sexual satisfaction in the majority of females and that the drug is not associated with addiction or misuse potential.

What Are the Contraindications of Flibanserin Oral Tablets?

The contraindications of Flibanserin oral tablets include:

• Patients who are allergic to Flibanserin or its ingredients.

• Women must not use Flibanserin oral tablets after menopause.

• Males must not use Flibanserin.

• This medicine must not be used to improve sexual performance.

• Flibanserin oral tablets are not recommended for pregnant females and lactating women.

• Flibanserin is contraindicated in patients with liver disorders or severe liver impairment, as it can increase the risk of fainting or hypotension.

What Are the Side Effects of Flibanserin Oral Tablets?

The possible side effects of Flibanserin oral tablets include:

• Nausea.

• Dry mouth.

• Difficulty swallowing.

• Constipation.

• Insomnia (difficulty sleeping).

• Tiredness.

• Blurred vision.

• Bloating sensation.

• Fever.

• Abdominal pain.

• Sweating.

• Confusion.

• Dizziness or lightheadedness when getting up suddenly from lying down or sitting position.

• Spinning sensation.

• Itching.

• Swelling of the face, mouth, and lips.

What Must the Patient Inform the Doctor Before Taking Flibanserin Tablets?

• Before starting the treatment, patients must inform their healthcare provider if they are allergic to Flibanserin, its components, or other medications.

• Patients must notify the doctor if they are taking medications such as Carbamazepine, Omeprazole, Pantoprazole, Rifampin, Ketoconazole, Fluconazole, oral contraceptives, sleeping pills, pain medicines, muscle relaxants, vitamins or nutritional supplements, herbal products, over-the-counter drugs, or any other medicines before starting treatment with Flibanserin tablets.

• Patients must tell the doctor if they are pregnant, breastfeeding, planning, or suspecting pregnancy before beginning treatment with Flibanserin.

• Patients must inform the doctor if they have liver problems, mental disorders, or any other diseases before starting the treatment.

What Are the Precautions Necessary While Taking Flibanserin Tablets?

• Flibanserin tablets must be stored at room temperature between 20 and 25 degrees Celsius (68 to 77 degrees Fahrenheit) away from excess heat and moisture.

• When taken during the day, Flibanserin tablets may cause accidental injuries and increase the risk of syncope (fainting), hypotension (low blood pressure), or central nervous system depression. Therefore, it is recommended to take them during bedtime.

• If the symptoms do not improve after eight weeks of treatment, the doctor must be informed, and the treatment can be discontinued.

• Flibanserin tablets can cause drowsiness or sleepiness. Hence, patients must not drive vehicles or operate heavy machinery for up to six hours after taking the medication.

• Patients must not consume alcohol or grapefruit juice during the treatment with Flibanserin as it increases the risk of low blood pressure or fainting. If alcohol is consumed, patients must wait at least two hours before taking Flibanserin.

• In case of an overdose, severe side effects, allergic reactions, fast heartbeat, persistent itching, unusual tiredness, or swelling of the face, hands, and feet, a healthcare provider must be consulted immediately.

• This medicine must not be shared with others even if they have similar symptoms; it must always be taken under the guidance of a healthcare professional.

• Flibanserin oral tablets can increase syncope or hypotension when taken with drugs such as Erythromycin, Clarithromycin, Verapamil, and Ciprofloxacin. Therefore, Flibanserin must be discontinued before two days if the patient requires any of these drugs.

• The patient is periodically monitored with Flibanserin during the treatment.

Conclusion

Flibanserin oral tablet is a prescription medicine that belongs to a class of drugs called serotonin receptor agonists/antagonists. It is recommended for the management of acquired and generalized hypoactive sexual desire disorder in females who have not attained menopause. It must be taken once daily during bedtime. It is a novel pharmacological agent, and studies have shown that it is well tolerated by most women. However, Flibanserin may be associated with certain adverse effects. Therefore, it is always better to consult a healthcare professional before taking this medication.