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FLIBANSERIN

ClassFLIBANSERIN commonly prescribed forHow FLIBANSERIN worksHow long until FLIBANSERIN worksNotable Side EffectsLife Threatening Side Effectsweight gainsedationWhat to do about FLIBANSERIN side effectsusual dosage rangeDosage Formslong term usehabit formingRenal ImpairmentHepatic ImpairmentCardiac ImpairmentElderlyChildren and AdolescentsPregnancyBreast Feeding

THERAPEUTICS

Class

  • Serotonin 1A agonist and serotonin 2A antagonist

FLIBANSERIN commonly prescribed for

(Bold for FDA approved)

• Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women

How FLIBANSERIN works

• Sexual dysfunction is theoretically linked to an imbalance in central excitatory and inhibitory sexual signals

• HSDD hypothetically results from excessive inhibitory signals, inadequate excitatory signals, or a combination of the two

• Flibanserin hypothetically counteracts this imbalance in HSDD through its ability to both reduce inhibitory signals and enhance excitatory signals

• Specifically, flibanserin increases the release of dopamine and norepinephrine, which are excitatory sexual signals, and reduces the release of serotonin, an inhibitory sexual signal

How long until FLIBANSERIN works

• In clinical trials, improvement was seen at 4 weeks

SIDE EFFECTS

Notable Side Effects

• Somnolence

• Nausea

• Fatigue

• Insomnia

• Dry mouth

Life Threatening Side Effects

• Dizziness, syncope, especially when combined with alcohol (contraindicated)

weight gain

unusual

unusual

sedation

common

common

What to do about FLIBANSERIN side effects

• Wait

• Wait

• Wait

• Review any concomitant medications and consider reducing the dose or discontinuing agents that may be interacting with flibanserin

• Switch to another treatment option

DOSING AND USE

usual dosage range

• 100 mg once daily at bedtime

Dosage Forms

• Tablet 100 mg

long term use

• Not studied

• However, flibanserin is recommended for long-term use with close monitoring

habit forming

• No

SPECIAL POPULATIONS

Renal Impairment

• Exposure may be increased

Hepatic Impairment

• Contraindicated; flibanserin exposure increases 4.5-fold in patients with hepatic impairment

Cardiac Impairment

• Use in patients with cardiac impairment has not been studied

Elderly

• Not approved for use in postmenopausal women

• Some elderly patients may theoretically tolerate lower doses better but this has not been formally studied

Children and Adolescents

• Safety and efficacy have not been established

Pregnancy

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

• In animal studies, fetal toxicity occurred only in the presence of significant maternal toxicity including reductions in weight gain and sedation

• In animal studies, decreased fetal weight, structural anomalies, and increases in fetal loss occurred with flibanserin at exposures greater than 15 times those achieved with recommended human doses

Breast Feeding

• Unknown if flibanserin is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Breast feeding is not recommended during treatment with flibanserin

Based on data Published online by Cambridge University Press

Compiled by Dr. Jash Ajmera