(Bold for FDA approved)
• 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
• In clinical trials, improvement was seen at 4 weeks
• Somnolence
• Nausea
• Fatigue
• Insomnia
• Dry mouth
• Dizziness, syncope, especially when combined with alcohol (contraindicated)
unusual
common
• 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
• 100 mg once daily at bedtime
• Tablet 100 mg
• Not studied
• However, flibanserin is recommended for long-term use with close monitoring
• No
• Exposure may be increased
• Contraindicated; flibanserin exposure increases 4.5-fold in patients with hepatic impairment
• Use in patients with cardiac impairment has not been studied
• Not approved for use in postmenopausal women
• Some elderly patients may theoretically tolerate lower doses better but this has not been formally studied
• Safety and efficacy have not been established
• 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
• 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