FLIBANSERIN

Class

• Serotonin 1A agonist and serotonin 2A antagonist

FLIBANSERIN commonly prescribed for

(Bold for FDA approved)

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

Notable Side Effects

• Somnolence

• Nausea

• Fatigue

• Insomnia

• Dry mouth

Life Threatening Side Effects

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

weight gain

unusual

sedation

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

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

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