FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

It’s a challenge to prove that any one treatment for desire is better than placebo.

• Flibanserin acts as an agonist on dopamine receptors and antagonist on certain serotonin receptors.
• The medication can take several weeks to show benefits.
• It is not approved for use in postmenopausal women.
• Flibanserin was initially developed as an antidepressant.
• It has a pharmacokinetic profile with a half-life of around 13 hours.
• Dose adjustments are necessary for patients with liver impairment.
• The drug can cause hypotension, especially with alcohol or CYP3A4 inhibitors.
• Patients are monitored for side effects such as sleepiness and low blood pressure.
• Flibanserin's efficacy is moderate and varies among women.

Flibanserin beat placebo on all self-report measures of desire, satisfaction, and distress in randomized controlled trials.

• Potential for negative publicity and stigma surrounding a "pink Viagra."
• Media coverage often oversimplifies its mechanism and expected results.
• Patient education is crucial to set realistic expectations about benefits.
• Support groups and online communities exist for women discussing HSDD treatment.
• Ongoing research continues to explore other pharmacologic targets for HSDD.
• Future developments may include new formulations or combination therapies.
• The approval of flibanserin spurred increased investment in female sexual health.
• It remains a subject of debate in medical ethics, women's health, and drug regulation.
• Prescribers should stay updated on post-marketing safety communications.

Most herbs and supplements that claim to increase desire contain combinations of several agents.

• Direct comparison trials between flibanserin and bremelanotide are lacking.
• Choice of treatment depends on patient preference, risk profile, and cost.
• Psychological and interpersonal factors are important contributors to HSDD.
• Combining medication with sex therapy or counseling may improve outcomes.
• Flibanserin does not increase libido in individuals without HSDD.
• It is not approved or intended for use as a recreational or enhancement drug.
• Off-label use, such as in postmenopausal women or men, is not supported by evidence.
• Healthcare providers must complete an online knowledge assessment for REMS certification.
• Certification must be renewed periodically according to the REMS program.

It’s very difficult scientifically to prove that even one agent makes a difference for desire.

More about flibanserin

Based on the data in the clinical trials, if you haven’t seen any effect on sexual desire after taking Addyi for 12 weeks, then you’re probably not a responder. If you’re able to feel desire for someone outside your primary relationship, then you probably don’t have HSDD as strictly defined in the flibanserin clinical trials. Does that mean that Addyi won’t help you? The studies were all done on women with generalized loss of sexual desire. No, the data seem to indicate that flibanserin doesn’t cause hypersexuality.

SMILES string

It didn’t make the women in the clinical trials want sex all the time. Which, by the way, probably doesn’t do much anyhow — unless you’re already in the mood. Since flibanserin tends to restore a woman’s natural desire, women on Addyi will probably find they have the same degree of good judgment as they had before they lost their libido. Women with HSDD typically report that they can’t shut off the “thinking and planning” parts of their minds enough to concentrate on sex. What flibanserin seems to do is to help a woman with HSDD to say “no” to all the other things she might be worrying about — so she can think about sex again.

How is this drug best taken?

As a sex therapist, I’m pretty confident Addyi won’t put me out of business. So restoring a woman’s biological desire is only part of the picture. I think one of the most exciting things is going to be collaboration between sex therapy and sexual medicine. That’s what’s going to lead to the most number of people getting the most effective help. If a woman takes Addyi for 8 to 12 weeks as directed, and doesn’t notice any difference in her libido, then it’s likely she’s a non-responder. When you combine several different agents, you’re basically admitting it’s more hope than science.

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For instance, a woman taking Addyi should avoid using alcohol, and should avoid certain medications such as fluconazole (Diflucan and others) that can increase blood levels of flibanserin.

What special dietary instructions should I follow?

The maximum time flibanserin has been studied in premenopausal women is 18 months, and it appears to keep working over that timespan without losing its effectiveness. But more research is going to be necessary before we can say how enduring the effects might be after stopping the drug. This question was looked at specifically in the clinical trials. Overall, patients did not gain weight on flibanserin. In fact, there was some tendency to weight loss. In my opinion, there are psychological contraindications as well.

Region	Estimated Cost per Month	Generic Version Available
USA	$400	No
EU	€350	No
Australia	AUD 550	No
India	Approx. $50 (generic)	Yes

For instance, the situation where a woman’s motivation to take medication comes from her partner, rather than from the woman herself.

What is Addyi (flibanserin)?

Almost half of women in clinical trials didn’t report much response to flibanserin. For women who don’t respond to Addyi, there are off-label prescription treatments such as bupropion (Wellbutrin and others) and very low dose testosterone gel. But since they’re off-label, they require a careful discussion with your doctor. You may specifically want to consult with a sexual medicine specialist. As a sex therapist who’s also an MD, I’ve seen many female patients report restored libido on bupropion. Don’t try it just because your partner wants you to.

Take-Home Points

For other patterns of symptoms (such as lifelong absence of desire, or desire for other people but not their primary partner), we don’t know how effective Addyi might be. There’s no laboratory test to confirm a diagnosis of HSDD. But that’s typical for conditions that involve the brain and mind. Diagnosis of such mental disorders usually relies on pattern recognition. Asking, “Do this patient’s symptoms fit any established patterns that research has shown respond to specific treatments?” In diagnosing HSDD, a clinician needs to ask, “Did this woman once have sexual desire?

Elderly Precautions

Does she seem to have lost it permanently? And have we ruled out all of the common things that can cause loss of desire — such as prescription medications or general unhappiness in the relationship?” If she meets this pattern, then it’s likely she has HSDD. It’s not just the loss of desire. It’s the impact of vanished libido on a woman’s sense of self, and on her relationships. Many women with HSDD fake excitement during sex, going through the motions while waiting for it to be over.

How do I store and/or throw out this drug?

Some women avoid being affectionate with their partners, for fear their partner will want sex. These kinds of behaviors can further diminish desire, and before long can cause serious problems in a relationship. In surveys, the majority of women with HSDD report that their loss of desire had negatively affected their self-confidence, their body image, and their feeling of connection with their partners. It’s not uncommon for HSDD to destroy a marriage. The clinical trials data suggest that flibanserin can take up to four weeks to see results, and up to eight or twelve weeks to see maximum results. A woman should only take Addyi if she herself wants to feel sexual again.

• 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.

It should be entirely her own choice. This will most likely be an active area of research.

Safety and efficacy

The two side effects that the FDA looked at most carefully before approving flibanserin were (1) sedation, and (2) dizziness or fainting due to a drop in blood pressure. Sedation was common in the clinical trials, and was usually mild. The FDA specifically asked for information on women’s ability to drive the next day after taking it. No evidence of driving impairment was detected. In fact, driving performance seemed to be better in people who’d taken flibanserin than in people who hadn’t taken it.

Generic Name

Dizziness, or fainting due to a drop in blood pressure, were less common. But serious drops in blood pressure were noted in many subjects in so-called “challenge studies” — where volunteers took flibanserin together with medications known to increase blood levels of the drug, or took the drug and then consumed the equivalent of 2-4 shots of liquor. Of note, most of the subjects in the alcohol challenge studies were men. Apparently it was not easy to find female volunteers willing to take this medication together with 2-4 shots of liquor in the morning. The results of these challenge studies led the FDA to mandate a “black-box warning” requiring patients to avoid using alcohol while taking flibanserin — and to avoid this medication while taking moderate to strong Cytochrome p450 inhibitors such as fluconazole (Diflucan and others) which can increase flibanserin blood levels.

Lactation Precautions

The clinical studies on flibanserin were done with women who vardenafil tablets had what we call “generalized, acquired HSDD.” All of these women were in long-term, stable monogamous relationships. They’d had sexual desire in the past, and were distressed at having lost it and wanted it back. The average length of time women in the study had suffered with HSDD was five years. These women reported feeling no desire for their partner, or for anyone else. For women who fit this profile, clinical trials data would predict a 46-60% chance of a meaningful response to flibanserin. Especially because there are many women with panic disorder, OCD, or serious depression for whom nothing else works. A lot of people are going to be curious about whether flibanserin can help women on SRI’s, and we’ll look forward to seeing the results when this research is done.

Feature	Flibanserin	Bremelanotide	Vyleesi
Approved for HSDD	Yes	No	Yes
Administration Route	Oral	Injectable	Injectable
Usage Frequency	Daily	As needed	As needed
Main Side Effects	Dizziness, nausea	Nausea, flushing	Nausea, reactions at injection site

Older women suffer from HSDD as well as younger ones.

Are there OTHER USES for this medicine?

Addyi is the trade name for flibanserin, a new non-hormonal prescription medication for hypoactive sexual desire disorder (HSDD) in women. Addyi/flibanserin is the first medicine ever specifically approved to treat loss of sexual desire in either men or women. It’s also potentially important for sexual science — since FDA approval of flibanserin is likely to lead to much more research on the neurochemistry of desire. But 46-60% of women with HSDD, or a little more than half, reported clear benefit from flibanserin in randomized placebo-control clinical trials. No one knows for sure what the mechanism is.

Common Adverse Effects

But serotonin in the brain inhibits sexual function, and flibanserin reduces brain serotonin activity — which may account for its effectiveness in restoring desire. Flibanserin also has indirect effects on dopamine and norepinephrine, which may be relevant as well. It acts specifically on serotonergic neurons in the brain, and has indirect effects on dopamine and norepinephrine. Serotonin in the brain is generally thought to put the brakes on sex. Flibanserin may help ease up on the serotonin braking system, so libido can get going again.

How is Addyi supplied (dosage forms)?

The clinical trials data presented to the FDA on flibanserin included results from over 11,000 patients — one of the largest data-sets ever presented in the FDA’s history. The safety of this medication has been evaluated more stringently than that of most new drugs approved by the FDA. That being said, there is still much that is unknown about flibanserin — as with any other recently-approved medication. Rare but serious side effects are sometimes only discovered after a drug has been in general use for months or years. So expect your prescriber to monitor your treatment carefully. Flibanserin has been studied in post-menopausal women with HSDD, and it appears to be effective.

Real Science. Real Results.

But the majority were at least somewhat depressed, so it’s difficult to know exactly buy vardenafil 40mg what the therapeutic mechanism was. The short answer is that a woman can stop Addyi anytime she wants. But what women really want to know of course is whether their libido, once it’s been restored, will stay restored after they go off the medicine. The technical term for it in sex therapy is “bridging” to unassisted sex. No one has yet studied how many women are going to be able eventually to “bridge” to not needing flibanserin, versus how many are going to keep needing it.