Vyleesi (bremelanotide) for low sexual desire in premenopausal women
Vyleesi is an FDA-approved injection for one specific problem: acquired, generalized low sexual desire that causes marked distress in women who have not gone through menopause. It is a peptide, not a hormone like estrogen or testosterone.
Information current as of November 10, 2026. Educational only. Confirm everything here with your own clinician before starting, stopping or changing any medication.
At a glance
What it is
Bremelanotide, a melanocortin receptor agonist. It is a small synthetic peptide that works in the brain, not on the sex hormones.
Approved for
Premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that is not caused by another condition, the relationship, or a medication.
How it is given
A single-use autoinjector under the skin of the abdomen or thigh, at least 45 minutes before expected sexual activity.
Label limits
No more than one dose in 24 hours. More than 8 doses in a month is not recommended.
Main side effects
Nausea in about 4 in 10 women, flushing, headache and injection site reactions. Blood pressure rises briefly after each dose.
Who should not use it
Women with uncontrolled high blood pressure or known cardiovascular disease, and women who are pregnant.
Uses
What Vyleesi is used for
Vyleesi has one FDA-approved use. It treats premenopausal women with acquired, generalized hypoactive sexual desire disorder, or HSDD. In plain terms, that means low sexual desire that used to be normal, shows up in every setting and with any partner, and bothers the woman enough to cause real distress.
The label is specific about what does not count. The low desire cannot be explained by another medical or psychiatric condition, by problems in the relationship, or by the effects of a medication or drug. Depression, thyroid disease, pain with sex and side effects from other medicines all need to be sorted out first, which is why a physician evaluation comes before any prescription.
What the label says it is not for
Vyleesi is not approved for postmenopausal women or for men. It is also not approved to improve sexual performance. Using it outside the approved group would be off-label, and the trials did not study those groups.
If your low desire began around menopause, the first conversation is usually about hormones, sleep, mood and your overall plan. See estradiol, testosterone and our guide to perimenopause and hormones for that side of the picture.
How it works
How it works and how it is given
Bremelanotide turns on melanocortin receptors. The ones that matter at the dose in the label are called MC1R and MC4R. MC4R sits on nerve cells in many parts of the brain. The label states plainly that the way Vyleesi improves desire in women is not known. We know it works on average in trials, but not exactly why.
It is not a daily medicine and it does not change your hormone levels. You use it as needed, before you expect sexual activity. It comes in a single-use prefilled autoinjector, and you inject under the skin of the abdomen or thigh at least 45 minutes before.
There are two firm limits on use. Do not take more than one dose in 24 hours, because closer doses can add to the effect on blood pressure. And more than 8 doses in a month is not recommended, mostly because of skin darkening.
Vyleesi is the brand-name, FDA-approved product, made by the manufacturer. Compounded versions of bremelanotide are a separate matter. They are not the FDA-approved drug, and the FDA has not evaluated them for safety, effectiveness or quality.
Evidence
What the RECONNECT trials showed
Two identical phase 3 trials, called RECONNECT, tested Vyleesi against placebo for 24 weeks. Together they enrolled 1,267 premenopausal women with acquired, generalized HSDD, average age 39. Women injected as needed and rated their desire and distress.
Desire score
On a scale from 1.2 to 6, women on Vyleesi gained about 0.5 to 0.6 points over 24 weeks. Women on placebo gained about 0.2. The difference between groups was about 0.35 points across both trials.
Distress score
On a 0 to 4 scale of how often a woman felt bothered by low desire, scores fell by about 0.7 on Vyleesi and 0.4 on placebo. The difference was about 0.33 points.
Who stayed in
More women on Vyleesi left the trials early: 40 percent versus 13 percent in one trial, and 39 percent versus 25 percent in the other. Nausea was the most common reason.
Those gains were statistically significant in both studies. They were also modest. A change of a third of a point on a five-point scale is real, and it also means that many women would not notice a large shift. Individual results vary widely.
A 52-week open-label extension followed. It had no comparison group, so it cannot show benefit with confidence. It did show no new safety signals over a year. Trials in other populations are not directly comparable, and these trials were mostly white women in the United States.
Safety
Side effects and what to watch for
The label lists these as the most common side effects, in women who took Vyleesi in the pooled phase 3 trials:
- Nausea in 40 percent, compared with 1 percent on placebo. It is worst with the first dose, about 21 percent, then falls to about 3 percent with later doses. It usually starts within an hour and lasts about two hours. 13 percent of women took an anti-nausea medicine.
- Flushing in 20 percent, headache in 11 percent, injection site reactions in 13 percent, and vomiting in nearly 5 percent.
Blood pressure and heart rate
Each dose raises blood pressure for a short time and slows the heart rate a little. In the studies the biggest rise was about 6 points on the top number and 3 on the bottom number, peaking two to four hours after the dose. Heart rate dropped by up to 5 beats per minute. The label asks your physician to check your cardiovascular risk and blood pressure before starting and from time to time afterward.
Skin darkening
Some women develop dark patches, called focal hyperpigmentation, on the face, gums or breasts. In the placebo-controlled trials it was reported in about 1 percent of women using up to 8 doses a month. In a separate study where women took it every day for 8 days, 38 percent developed it. Women with darker skin were more likely to be affected, and it may not fully go away after stopping. Tell your physician about any skin change.
Call your physician for
- Nausea or vomiting that does not settle
- New dark patches on the skin, gums or breasts
- Chest pain, a racing or very slow heartbeat, or a severe headache
- Yellow skin or eyes, or dark urine (a single case of acute hepatitis was reported in an extension study)
Who should not use it
Who should not use Vyleesi, and what it interacts with
The label says Vyleesi is contraindicated in women with uncontrolled high blood pressure or known cardiovascular disease. It is not recommended for women at high risk of cardiovascular disease. That makes your blood pressure readings and your history central to the decision.
Pregnancy. Using Vyleesi during pregnancy is not recommended. In animal studies, bremelanotide caused fetal harm at higher exposures, and human data are too limited to say. Women who can become pregnant should use effective contraception and stop the medicine if pregnancy is suspected.
Naltrexone. Vyleesi can lower blood levels of naltrexone taken by mouth, and the label says to avoid using it with oral naltrexone products meant to treat alcohol or opioid addiction. Vyleesi can also slow stomach emptying, so it may change how some other pills are absorbed. Bring your full medication list to the visit. See our naltrexone page.
Kidney, liver and age. The label advises caution in severe kidney or liver disease, because nausea and vomiting can be worse. Safety and effectiveness have not been established in women over 65 or in children.
Summit’s role
What Summit does with Vyleesi
Dr. Miranda can prescribe Vyleesi after a physician evaluation. That evaluation covers your history, your blood pressure, your medications, your hormones and whether something else is behind the low desire. The prescription is filled by a pharmacy. Summit does not dispense or sell it.
Nothing on this page promises a prescription. If Vyleesi does not fit, you will hear why. See pricing for what the program includes, and hormone therapy if your symptoms point that direction.
Common questions
Questions people ask
Is Vyleesi a hormone?
No. It is a peptide that acts on melanocortin receptors in the brain. It does not contain estrogen, progesterone or testosterone and it is not a replacement for them.
Is Vyleesi the same as PT-141?
Bremelanotide is the generic name of the drug sold as Vyleesi. PT-141 is another name used for the same molecule outside the FDA-approved product. Only Vyleesi is the FDA-approved version, with a reviewed label.
Can I use it after menopause?
It is not approved for postmenopausal women, and the trials did not study them. A physician can talk with you about other approaches first. Using it outside its approval would be off-label.
How soon does it work, and how often can I use it?
The label says to inject at least 45 minutes before expected activity. The length of effect is not known. Use no more than once in 24 hours, and the label does not recommend more than 8 doses in a month.
Will it make me feel sick?
Many women do, mostly with the first dose. About 40 percent had nausea in the trials, and it usually lasts about two hours. It tends to fall with later doses. Some women need an anti-nausea medicine and some stop because of it.
Sources
Where this comes from
All retrieved November 10, 2026.
- VYLEESI (bremelanotide injection) prescribing information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
- Kingsberg SA et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol 2019. https://pubmed.ncbi.nlm.nih.gov/31599840/
- Clayton AH et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol 2019. https://pubmed.ncbi.nlm.nih.gov/31599847/
- Safety Profile of Bremelanotide Across the Clinical Development Program. 2022. https://pubmed.ncbi.nlm.nih.gov/35147466/
Confirm with your provider. This page is general education, not medical advice, and it does not diagnose or treat anything. Every medication carries risks and is not right for everyone. Medication is prescribed only after a physician evaluation determines it is appropriate for you. Individual results vary and no outcome is guaranteed. Information current as of November 10, 2026.
Next step
Start with a physician evaluation
Dr. Miranda reviews your history, blood pressure and medications first. Whether Vyleesi fits is part of that visit.