Vyleesi for Women: What You Need to Know About the Sex Drive Drug
A guide to Vyleesi, the FDA-approved, on-demand treatment for low sexual desire in premenopausal women.
What Is Vyleesi?
Vyleesi (bremelanotide) is the first and only FDA-approved, as-needed treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women—specifically, women who have not gone through menopause and who have not previously had problems with sexual desire. HSDD is characterized by low sexual desire that causes distress and is not due to medical or mental health issues, relationship problems, or medication side effects. Vyleesi is injected under the skin at least 45 minutes before anticipated sexual activity and is not taken daily.
How Does Vyleesi Work?
Vyleesi works by activating melanocortin receptors in the brain, which are thought to play a role in regulating sexual behavior and mood. While the exact mechanism is not completely understood, it is believed that stimulating these receptors helps increase sexual desire and reduce the distress associated with low libido. Unlike other treatments, Vyleesi is used only when needed, not every day, and there are fewer restrictions on alcohol use compared to some other medications.
Who Is Vyleesi For?
Vyleesi is specifically indicated for premenopausal women with acquired, generalized HSDD—meaning their low sexual desire developed after a period of normal function and is not limited to specific situations or partners. It is not approved for use in men, postmenopausal women, or for improving sexual performance. Women with uncontrolled high blood pressure or known heart (cardiovascular) disease should not use Vyleesi.
Clinical Effectiveness
Vyleesi’s approval was based on two identical clinical trials involving over 1,200 premenopausal women, aged 19–56, with an average age of 39. In these studies, women who used Vyleesi reported increased sexual interest and decreased distress related to low sex drive. Notable findings include:
- About a quarter of participants reported some increase in desire.
- Most women who completed the study chose to continue using Vyleesi in an open-label extension phase.
- The drug is intended to be used as needed, typically two to three times per month, and not more than once a week.
How to Use Vyleesi
- Vyleesi is self-administered as a subcutaneous injection into the abdomen or thigh, at least 45 minutes before sexual activity.
- No more than one dose should be used in 24 hours, and not more than eight doses per month.
- It is not a daily medication and is taken only when sexual activity is anticipated.
Common Side Effects
Like all medications, Vyleesi can cause side effects. The most common include:
- Nausea (sometimes severe enough to cause discontinuation in clinical trials).
- Flushing
- Injection site reactions
- Headache
- Vomiting
Less commonly, some women may experience hyperpigmentation (darkening of the skin or gums), which may persist after stopping the medication.
Precautions and Contraindications
- High blood pressure: Women with uncontrolled hypertension or known heart disease should not use Vyleesi due to the risk of increased blood pressure.
- Alcohol: Unlike some other sex drive medications, Vyleesi can generally be used with alcohol, though moderation is always advised.
- Pregnancy and breastfeeding: The safety of Vyleesi in pregnant or breastfeeding women has not been established.
Vyleesi vs. Other HSDD Treatments
| Treatment | Type | Approved For | Alcohol Restrictions | Common Side Effects |
|---|---|---|---|---|
| Vyleesi (bremelanotide) | Injectable, as needed | Premenopausal women | No significant restrictions | Nausea, flushing, injection site reactions, headache, vomiting |
| Addyi (flibanserin) | Daily pill | Premenopausal women | Alcohol contraindicated | Dizziness, sleepiness, nausea, fatigue |
Addyi, the other FDA-approved medication for HSDD, works through a different mechanism and is taken daily, not as needed. It also has significant restrictions on alcohol use.
When to Talk to Your Doctor
Women who are bothered or distressed by their low sexual desire should discuss it with their healthcare provider. It’s important to rule out underlying medical, psychological, or relationship issues that may contribute to low libido. For situational low sex drive or relationship concerns, counseling or sex therapy may be more appropriate.
Frequently Asked Questions (FAQs)
Q: Who can use Vyleesi?
A: Vyleesi is approved for premenopausal women who have troubling, persistent low sexual desire not due to medical, mental health, or relationship problems, or medication side effects.
Q: How often can I use Vyleesi?
A: You can use Vyleesi as needed, at least 45 minutes before sexual activity, but not more than once in 24 hours or eight times per month.
Q: What are the most common side effects?
A: Nausea, flushing, injection site reactions, headache, and vomiting are the most common side effects.
Q: Can I drink alcohol while using Vyleesi?
A: Unlike Addyi, there are no significant alcohol restrictions with Vyleesi, though moderation is always wise.
Q: Is Vyleesi approved for men or postmenopausal women?
A: No, Vyleesi is only approved for premenopausal women; it is not for men or postmenopausal women.
Q: What should I do if I experience side effects?
A: Contact your healthcare provider if you have bothersome or persistent side effects, especially nausea or changes in skin color.
Key Takeaways
- Vyleesi is the first FDA-approved, as-needed treatment for low sexual desire in premenopausal women with HSDD.
- It is injected under the skin at least 45 minutes before sexual activity and is not taken daily.
- Clinical trials show it can increase sexual desire and reduce related distress, though not all women will respond.
- Common side effects include nausea, flushing, and injection site reactions.
- Vyleesi is different from Addyi, which is a daily pill with more alcohol restrictions.
- Women concerned about low sex drive should talk to their healthcare provider to determine the best approach for their situation.
Conclusion
Vyleesi offers a new, as-needed option for premenopausal women struggling with troubling low sexual desire. It is not a cure-all, but for some, it may help restore sexual interest and improve quality of life. As with any medication, it’s important to weigh the potential benefits against the risks and to consult a healthcare provider to determine if Vyleesi is right for you.
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