Flibanserin

ADDYI

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Pronunciation: flib-AN-ser-in

Flibanserin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Flibanserin ballicule

Flibanserin ADDYI mascot mnemonic cartoon — Visual mnemonic: Flibanserin mascot
**“Flibbin’ seriously Addicted (to love)”**

What it is5-HT1A agonist and 5-HT2A antagonist; hypoactive sexual desire disorder in premenopausal women.

Why this oneUses 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.

Flibanserin molecular structure (skeletal formula) — Molecular structure: Flibanserin

FDA-approved for

hypoactive sexual desire disorder (women) (2015)

Classes and tags

Narrow therapeutic index (NTI) drugs

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability2 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

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.

FDA label

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BOXED WARNING Severe hypotension and syncope with alcohol, with moderate/strong CYP3A4 inhibitors, or in hepatic impairment.

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

Available strengths

tab 100 mg

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).

Cost

Flibanserin (ADDYI)

Strength		#/mo	generic $/mo	CostPlus
100 mg	tab	30 qd		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Flibanserin is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2031 est.

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Memory aids: interaction avatars

CYP2C19 substrate

CYP3A4 substrate

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Self-check

Is flibanserin taken daily or on demand?
Daily.
What can combining flibanserin with alcohol cause?
Hypotension and syncope.