FDA Expands Addyi Approval to Treat Postmenopausal Libido –  What It Means and What to Know

Low sexual desire after menopause is common, and on December 15, 2025 the FDA expanded the label for Addyi (flibanserin) to include some postmenopausal women. This is a notable change: Addyi was first approved in 2015 for certain premenopausal women, and the new decision gives doctors another FDA‑cleared option for women under 65 who meet the diagnosis of hypoactive sexual desire disorder (HSDD).¹ 

What exactly was approved

The FDA’s expanded approval allows Addyi (100 mg, taken once daily at bedtime) to be prescribed for postmenopausal women under age 65 who have acquired, generalized HSDD  –  meaning a persistent lack of sexual desire that causes distress and is not caused by another medical condition, relationship problems, or medication effects. The decision followed clinical trials and a priority review process that evaluated safety and benefit for this group.² 

How Addyi works  –  simple explanation

Addyi is not a hormone. It’s a pill that acts on brain chemicals (neurotransmitters) involved in sexual desire and mood. Think of it as a medication that aims to shift the balance of brain signals that can dampen desire, rather than replacing hormones like estrogen or testosterone. It’s taken every night at bedtime, and doctors usually stop it after 8 weeks if there’s no improvement.

What the studies found

Clinical trials in postmenopausal women showed modest improvements in measures of desire and related distress compared with placebo. One randomized trial (PLUMERIA) found a statistically significant improvement on a standard desire questionnaire, though not every outcome (like number of satisfying sexual events) reached statistical significance in every study. The overall picture from the research is that some women experience meaningful benefit, while others do not  –  which is why doctors typically reassess after a trial period.²

Side effects and safety at a glance

Below is a clear chart of the most commonly reported side effects, important warnings, and practical cautions to keep in mind. Read it before you consider taking Addyi and share it with your clinician.

What to watch for	How common / what it looks like	What to do
Dizziness	Reported in trials; can be lightheadedness or balance issues	Avoid driving or heavy machinery until you know how it affects you
Sleepiness or sedation	Feeling unusually sleepy or groggy the next day	Take at bedtime; avoid alcohol and other sedating drugs
Nausea	Mild to moderate stomach upset	Take with food if advised; talk to your doctor if persistent
Fatigue	Ongoing tiredness reported by some users	Monitor energy levels; discuss with clinician
Insomnia	Trouble falling or staying asleep	Report to your doctor; may need dose review
Dry mouth	Common minor side effect	Stay hydrated; sugar-free gum or lozenges may help
Risk of low blood pressure and fainting when combined with alcohol or certain drugs	Can be severe; boxed warning exists for alcohol interaction and for interactions with some medications and liver problems	Do not drink alcohol close to dosing; avoid certain medicines and check liver function

Important cautions and interactions

• Alcohol: Combining Addyi with alcohol can cause dangerously low blood pressure and fainting. Patients are advised to avoid alcohol from the time they take the bedtime dose until the next morning; if you drank several drinks earlier in the evening, you may be told to skip that night’s dose.
• Other medications: Some common drugs raise flibanserin levels (increasing side effect risk) or lower them (reducing effectiveness). Strong or moderate CYP3A4 inhibitors are contraindicated; certain antidepressants, antifungals, and antibiotics may interact. Tell your doctor about every prescription, over‑the‑counter drug, and supplement you take.
• Liver problems: Addyi is not recommended for people with liver impairment because the drug can build up and increase risk of low blood pressure and fainting.
• Driving and operating machinery: Because Addyi can cause sleepiness and dizziness, avoid activities that require full alertness until you know how the drug affects you.
• Age limit: The expanded approval covers postmenopausal women under 65; your doctor will confirm whether you fit the approved group and whether other causes of low desire have been ruled out.

These cautions are why doctors typically do a careful review of your medications, liver health, alcohol use, and overall medical history before prescribing Addyi.

Who is a good candidate

Addyi is intended for women who:

• Are postmenopausal and under 65, and
• Have acquired, generalized HSDD that causes marked distress, and
• Have had other causes ruled out (medical conditions, relationship issues, medications), and
• Can follow safety rules (no alcohol around dosing, no contraindicated drugs, normal liver function).

It’s not for women whose low desire is explained by relationship problems, depression, or side effects of other medications  –  those issues should be addressed first.

Practical tips if you and your doctor consider Addyi

• Start at bedtime and follow the exact dosing instructions. If you miss a dose, don’t double up the next night.
• Give it time: clinicians often reassess after about 8 weeks and stop the drug if there’s no improvement.
• Avoid alcohol from dosing until the next morning; if you had several drinks, skip that night’s dose.
• Keep a simple diary of desire, distress, and any side effects to share with your clinician  –  this helps decide if the drug is helping.
• Ask about alternatives: non‑drug approaches (therapy, relationship counseling, addressing vaginal dryness) and other medical options may be appropriate depending on the cause of low desire.

How to talk to your doctor about Addyi

Talking about sexual desire can feel awkward, but a clear, practical conversation helps you and your clinician make the best decision. Here’s a short script and checklist you can use.

Quick script

“I’ve been experiencing low sexual desire since menopause, and it’s causing me distress. I read that Addyi is now approved for some postmenopausal women. Can we talk about whether this might be appropriate for me, what the benefits and risks are, and what other options I should consider?”

Checklist to bring to the appointment

• A short timeline of when low desire started and how it affects you.
• A list of current medications, supplements, and alcohol use.
• Any medical history, especially liver problems or fainting spells.
• Notes on sleep, mood, relationship stress, and vaginal symptoms (dryness, pain).
• Your goals: what would “better” look like for you?

Questions to ask

1. Am I a candidate for Addyi?
2. What are the likely benefits for someone like me?
3. What side effects should I expect and how common are they?
4. How will we monitor safety (liver checks, interactions)?
5. How long should I try it before deciding if it helps?
6. Are there non‑drug options I should try first or alongside medication?

A frank, nonjudgmental conversation will help your clinician tailor care to your needs and safety profile.

A Better Tomorrow

The FDA’s expanded approval of Addyi for some postmenopausal women gives an additional, non‑hormonal option for treating distressing low sexual desire. The benefits are modest for many women, and the drug comes with important safety rules  –  especially around alcohol, certain medications, and liver health. If you’re considering Addyi, prepare for an open conversation with your clinician, bring a list of medications and health history, and plan to reassess after a trial period to see if it’s helping you reach your goals.

Sources (7) 

1. Flibanserin in Postmenopausal Women PLUMERIA study  –  Journal of Sexual Medicine: https://academic.oup.com/jsm/article/14/6/834/6973373 
2. ClinicalTrials.gov record for flibanserin in postmenopausal women: https://clinicaltrials.gov/study/NCT00996372?tab=table 
3. Managed Healthcare Executive coverage of FDA approval: https://www.managedhealthcareexecutive.com/view/fda-approves-first-postmenopausal-libido-treatment-addyi 
4. FDA Prescribing Information (label highlights PDF): https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf?viewType=Print&viewClass=Print 
5. Addyi and alcohol/food interactions (Drugs.com): https://www.drugs.com/food-interactions/flibanserin,addyi.html 
6. Official Addyi Prescribing Information (manufacturer): https://addyi.com/pi/ 
7. Sprout Pharmaceuticals press release on expanded approval: https://www.prnewswire.com/news-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women-302642397.html