Flibanserin
ADDYI
What it is5-HT1A agonist and 5-HT2A antagonist; hypoactive sexual desire disorder in premenopausal women.
Why this oneIt uses a daily central mechanism rather than an on-demand hormonal or vascular one.
What limits itAlcohol or CYP3A4 inhibitors can cause hypotension and syncope; the modest benefit must justify continuous exposure.
FDA-approved for
- hypoactive sexual desire disorder (women) (2015)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Acquired, generalized hypoactive sexual desire disorder (HSDD) | Premenopausal women | 100 mg QHS | 100 mg QHS | 100 mg QHS |
Renal Undefined
Hepatic Contraindicated in hepatic impairment
Instructions
- Take once daily at bedtime
- Avoid alcohol; wait ≥2 h after 1–2 standard drinks; skip the dose if ≥3 drinks that evening
- Discontinue after 8 weeks if no symptom improvement
- If a dose is missed, take the next dose at bedtime the next day; do not double
Contraindications
- Concomitant moderate or strong CYP3A4 inhibitors
- Hepatic impairment (any degree)
Cautions
- Hypotension and syncope from alcohol interaction
- CNS depression (somnolence, sedation)
- Hypotension and syncope with ADDYI alone
- Hypersensitivity reactions incl. anaphylaxis, angioedema
Adverse reactions
- Dizziness
- Somnolence
- Nausea
- Fatigue
- Insomnia
- Dry mouth
- Anxiety
Pregnancy No human data; animal fetal toxicity only at maternally toxic doses.
Lactation Not recommended while breastfeeding (potential for infant sedation).
⚠ BOXED WARNING
- Hypotension and syncope with alcohol or CYP3A4 inhibitors
Cost, est. cash$400–$1,000/month
Generic entry2031 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Flibanserin ballicule
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