Updated: January 25, 2026
What Is Vyleesi? Uses, Dosage, and What You Need to Know in 2026
Author
Peter Daggett

Summarize with AI
Vyleesi (bremelanotide) is an FDA-approved injectable for HSDD in premenopausal women. Learn about its uses, dosage, how to take it, and what to expect.
Vyleesi is a prescription injectable medication FDA-approved in 2019 for premenopausal women with hypoactive sexual desire disorder (HSDD). If you've been diagnosed with HSDD or your doctor has mentioned Vyleesi, here's a complete overview of what it is, how it works, and what to expect from treatment.
What Is Vyleesi?
Vyleesi is the brand name for bremelanotide, a melanocortin receptor (MCR) agonist. It was FDA-approved on June 21, 2019, and is currently manufactured and marketed by Cosette Pharmaceuticals. Vyleesi is one of only two FDA-approved prescription medications specifically indicated for HSDD in premenopausal women (the other being Addyi/flibanserin).
Unlike Addyi, which is a daily oral pill, Vyleesi is an on-demand injectable — you only take it when you anticipate sexual activity. It comes as a single-dose prefilled autoinjector pen and is self-administered just under the skin (subcutaneous injection) of the abdomen or thigh.
What Is Vyleesi Used For?
Vyleesi is FDA-approved for one specific indication: treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Let's break that down:
- Hypoactive sexual desire disorder (HSDD): A recognized medical condition defined by a persistent, troubling lack of sexual desire — not simply a low libido from time to time.
- Acquired: The low desire developed over time — you previously had a satisfying level of sexual desire and that changed.
- Generalized: The low desire occurs regardless of the type of sexual activity, the situation, or the partner — it's not situational.
- Premenopausal: Vyleesi is approved for premenopausal women only. It is not indicated for postmenopausal women or men, and should not be used to enhance sexual performance in people who don't have HSDD.
Additionally, the HSDD must not be caused by a medical or psychiatric condition, relationship problems, or medication side effects. Your provider will rule out these causes before diagnosing HSDD.
Vyleesi Dosage: How Much and How Often?
The FDA-approved dose of Vyleesi is:
- Dose: 1.75 mg bremelanotide in 0.3 mL solution, delivered via a single-dose autoinjector
- When to take it: At least 45 minutes before anticipated sexual activity
- How to take it: Subcutaneous injection (under the skin) into the abdomen or thigh using the autoinjector — it can be used at any time of day
- Frequency limits: No more than one dose in 24 hours; no more than 8 doses per month
In clinical trials, most patients used Vyleesi 2–3 times per month. You don't need to use it daily or on a fixed schedule — it's designed around your actual needs.
Does Vyleesi Work? What the Clinical Trials Show
Vyleesi was studied in two 24-week, randomized, double-blind, placebo-controlled trials involving 1,247 premenopausal women with acquired, generalized HSDD. The results showed:
- About 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (on a 1.2–6.0 scale), compared to about 17% of placebo patients
- Both clinical trials showed meaningful reductions in distress related to low sexual desire
- Vyleesi did not consistently increase the number of sexually satisfying events across all trials
In short: Vyleesi helps some women with HSDD experience meaningful improvement in desire and distress — not everyone, but a significant proportion. Like most medications for complex conditions, it doesn't work for every patient.
Key Things to Know Before Starting Vyleesi
- It is a prescription medication — you cannot buy it over the counter
- It is not a controlled substance — no special prescriber certification is required
- It is only available through specialty pharmacies — not at CVS, Walgreens, or standard retail chains
- Nausea is common (~40% of users), especially with the first dose — usually improves over time
- Use effective contraception while on Vyleesi
- Do not use if you have uncontrolled hypertension or known cardiovascular disease
Want to understand the science behind how Vyleesi works? Read our guide on Vyleesi's mechanism of action explained in plain English.
Ready to fill your prescription? medfinder helps you find specialty pharmacies near you that can fill Vyleesi so you can get started.
Frequently Asked Questions
Vyleesi is sometimes called "female Viagra" in popular media, but the comparison isn't accurate. Viagra works on blood flow to the genitals. Vyleesi works on brain pathways (melanocortin receptors) to increase sexual desire. They address different aspects of sexual function with entirely different mechanisms.
Vyleesi starts working within 45 minutes of injection. That's why you take it at least 45 minutes before anticipated sexual activity. The effects can last several hours, though the timing of peak effectiveness varies between individuals.
Officially, no. Vyleesi is FDA-approved only for premenopausal women with HSDD. It is not indicated for postmenopausal women or men. Some providers prescribe it off-label for postmenopausal women, but this is outside the FDA-approved indication.
No. Vyleesi (bremelanotide) is not a controlled substance. It has no DEA scheduling. Any licensed prescriber can write a Vyleesi prescription without special registration or certification.
No generic version of Vyleesi is currently available. Based on patent analysis, the earliest potential generic entry is estimated around November 2033. Until then, Vyleesi is only available as the brand-name product from Cosette Pharmaceuticals.
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