FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder
2020]Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment.Kingsberg SA, Simon JA. This medication is used to treat women who have not gone through menopause who have low sexual desire and are concerned about it.
dopamine, norepinephrine, and serotonin3
Studies have not been conducted on pregnant women to determine any associated risks concerning maternal or fetal toxicity. However, fetal toxicity was observed in animal studies, which included sedation, anatomical abnormalities, and limited weight gain. Animal studies showed fetal loss was increased at doses 15 times greater than pharmacological doses in humans. [16] In a case report published in the American College of Medical Toxicology (ACMT), a pediatric patient aged 2 inadvertently ingested 7 tablets of 100-mg flibanserin. This led to profound CNS depression in the child, necessitating endotracheal intubation.
SMILES string
The patient was discharged without enduring sequelae following extubation on the third day of hospitalization. This case highlights the importance of securely storing medications to prevent unintended pediatric poisonings. When a new medication is introduced in the market, healthcare professionals and patients should be educated regarding its use, indications, and potential adverse events. This education aims to enhance healthcare outcomes and minimize adverse effects of the drug. Interprofessional team members should comprehend the contraindications and possible drug interactions associated with flibanserin use.
Brand Names: US
Flibanserin is a novel pharmacological agent for treating acquired, generalized HSDD in premenopausal women. The flibanserin medication guide provides specific instructions to educate patients on safe alcohol consumption while taking flibanserin, aiming to mitigate the risk of hypotension and syncope. Similar to other CNS depressant medications, patients should receive counseling about the increased risk of CNS depression when coadministered with flibanserin. Moreover, patients should receive guidance on potential adverse events associated with the medication, as discussed in the previous section. In addition, healthcare team members should conduct a comprehensive medication review to identify any drugs mentioned earlier that may interact with flibanserin. Flibanserin should not be used to treat low sexual desire caused by: a medical or mental/mood disorder, problems in the relationship, or the effects of other drugs. This medication should not be used by women who have gone through menopause, or by men.
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Flibanserin is not used to enhance sexual performance.
- Clinical trials excluded women with many comorbidities (e.g., unstable medical conditions).
- Real-world effectiveness in broader populations may differ from trial results.
- Patient satisfaction with treatment can vary widely.
- Some women report significant improvement in sexual desire and distress.
- Others discontinue due to side effects or lack of meaningful benefit.
- Adherence to daily dosing is a challenge for some patients.
- The bedtime dosing schedule is intended to mitigate side effects like dizziness.
- Taking it with a high-fat meal can increase absorption and side effect risk.
- Should be taken on an empty stomach, at least 2 hours after a high-fat meal.
100 mg Brand(s): Addyi(R), Sprout film-coated Read the Medication Guide provided by your pharmacist before you start taking flibanserin and each time you get a refill.
| Parameter | Description | Typical Values |
|---|---|---|
| Absorption | Rapid, high bioavailability | ~52% |
| Peak Plasma Levels | 1-2 hours after dosing | ~1.5 hours |
| Half-life | Duration of effect | 11 hours |
| Metabolism | Hepatic via CYP3A4 | Major route |
| Excretion | Mainly via urine | 87% in urine |
If you have any questions, ask libido booster for woman your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Take flibanserin only at bedtime to reduce your risk of low blood pressure, fainting, and drowsiness while you are awake. After taking flibanserin, do not drink any alcohol until the next day. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Take this medication regularly to get the most benefit from it.
What should I know about storage and disposal of this medication?
Patient education should also emphasize the significance of bedtime dosing to prevent hypotension and syncope. Flibanserin has been available in the United States for over 8 years, and continuous postmarketing safety monitoring has not revealed any new safety signals. Furthermore, a 52-week open-label extension study involving 1723 premenopausal women with acquired, generalized HSDD who had previously completed a flibanserin trial demonstrated that the medication was well-tolerated. The study also found that sexual function improved in women who were not FSFI remitters at baseline, and this improvement was sustained in those who were remitters at baseline. Interprofessional healthcare team members must be aware of the obstacles preventing them from prescribing flibanserin to patients.
What do I do if I miss a dose?
This will help patients receive the most effective and personalized treatment for HSDD. Some of these barriers include the high treatment cost, potential drug interactions, and individual-specific adverse effects. The availability of flibanserin, along with non-pharmacological therapies, will enhance the treatment options for premenopausal women affected by HSDD. Effective communication and coordination among clinicians (MD, DO, NP, and PA), pharmacists, specialists, and nurses are pivotal in optimizing patient outcomes related to flibanserin pharmacotherapy and reducing the likelihood of potential adverse drug reactions. Female hypoactive sexual desire disorder: epidemiology, diagnosis and treatment.
Learn to recognize the signs of HSDD in your patients.4
Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment. National Center for Biotechnology Information (US); Bethesda (MD): Sep 23, 2019. Female Sexual Dysfunction: ACOG Practice Bulletin Summary, NUMBER 213. Treatment of Hypoactive Sexual vigora 200 mg Desire Disorder Among Women: General Considerations and Pharmacological Options. Flibanserin (Addyi): The First FDA-Approved Treatment for Female Sexual Interest/Arousal Disorder in Premenopausal Women. To help you remember, take it at the same time each day. Tell your doctor if your condition does not get better after 8 weeks of treatment. If you miss a dose, skip the missed dose. Take your next dose at bedtime the next day. Do not double the dose to catch up. Warning: Breastfeeding is not recommended while using this drug.
IN THEIR WORDS
Accidental Flibanserin Ingestion in Children Causing Acute Respiratory and Central Nervous System Depression: What Health Care Professionals Need to Know. Next-day residual effects of flibanserin on simulated driving performance in premenopausal women. 2017 Jul;32(4) [PMC free article: PMC5697607] [PubMed: 28568608] Abstracts from the 2017 American College of Medical Toxicology (ACMT) Annual Scientific Meeting. Disclosure: China Pierrelus declares no relevant financial relationships with ineligible companies. Disclosure: Preeti Patel declares no relevant financial relationships with ineligible companies.
Generic Name
Disclosure: Karen Carlson declares no relevant financial relationships with ineligible companies. Review New developments in the treatment of hypoactive sexual desire disorder - a focus on Flibanserin. 2017]Review New developments in the treatment of hypoactive sexual desire disorder sex medicine - a focus on Flibanserin.Jayne CJ, Heard MJ, Zubair S, Johnson DL. 2020]Review Evaluation of safety for flibanserin.Clayton AH, Brown L, Kim NN. Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.
Dosage and Administration
2022]Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.Simon JA, Clayton AH, Kim NN, Patel S. Sex Med. Review Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. 2015]Review Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.Dhanuka I, Simon JA. Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment. Alcohol and marijuana may intensify this effect. Use care when operating a vehicle, vessel (e.g., boat), or machinery. If you drink alcohol, discuss the safe use of alcohol while using this medication with your healthcare professional.
| Aspect | Details |
|---|---|
| Chemical Formula | C_20H_21F_3N_4O |
| Molecular Weight | 370.41 g/mol |
| Key Functional Groups | Triazole ring, fluorinated phenyl group |
| Structural Type | Non-steroidal compound |
Do not eat grapefruit or drink grapefruit juice at any time while taking this medication. See also Warning and How to Use sections. Drug interactions may change how your medications work or increase your risk for serious side effects.
Society and culture
Roles of 5-HT receptors in the release and action of secretin on pancreatic secretion in rats. [The pharmacological basis of the serotonin system: Application to antidepressant response]. Invernizzi RW, Sacchetti G, Parini S, Acconcia S, Samanin R. Flibanserin, a potential antidepressant drug, lowers 5-HT and raises dopamine and noradrenaline in the rat prefrontal cortex dialysate: role of 5-HT(1A) receptors. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].
Storage Class
National Institute of Diabetes and Digestive and Kidney Diseases; Bethesda (MD): Jan 26, 2018. Female sexual dysfunction: a focus on flibanserin. Gelman F, Atrio J. Flibanserin for hypoactive sexual desire disorder: place in therapy. Holt H, Tingen J.
How is Addyi supplied (dosage forms)?
Flibanserin (Addyi) for Hypoactive Sexual Desire Disorder in Premenopausal Women. Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder. Flibanserin for Treating Hypoactive Sexual Desire Disorder. Clayton AH, Croft HA, Yuan J, Brown L, Kissling R. Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of flibanserin from your body, which may affect how flibanserin works. Examples include azole antifungals (such as fluconazole, ketoconazole), certain calcium channel blockers (such as diltiazem, verapamil), macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
| Region | Estimated Cost per Month | Generic Version Available |
|---|---|---|
| USA | $400 | No |
| EU | €350 | No |
| Australia | AUD 550 | No |
| India | Approx. $50 (generic) | Yes |
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
- Flibanserin is used to treat premenopausal women with hypoactive sexual desire disorder (HSDD).
- It is marketed under the brand name Addyi.
- Flibanserin works by modulating serotonin and dopamine levels in the brain.
- It was approved by the FDA in 2015 for HSDD treatment.
- Common side effects include dizziness, nausea, and fatigue.
- Flibanserin is usually taken once daily at bedtime.
- It has contraindications with alcohol due to risk of severe hypotension.
- Patients should avoid alcohol while using flibanserin.
- It is a non-hormonal medication specifically for sexual desire issues.
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