(WellsYI-M Cap)
Available Dosage Strengths
75 mg / 1 mg
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Flibanserin / Melatonin Description1-5
Flibanserin has been used to treat hypoactive sexual desire disorder in premenopausal women. The goal of the medication is to increase sexual desire and the number of satisfying sexual events. Flibanserin, which has generally been administered at bedtime, has a half-life of 11 hours. After oral administration, Flibanserin reaches its peak concentration within 45 minutes, is approximately 33% orally bioavailable, and reaches steady state within 3 days.
Melatonin, a neurohormone, has been used to regulate circadian rhythm. Melatonin has been used in jet lag and sleep disorders, irregular sleep-wake disorders, shift-work disorders and non-24-hour sleep disorders in adults. Flibanserin may cause insomnia in some patients and is combined with melatonin to facilitate sleep.
Flibanserin1,2
An imbalance in the neurotransmitters dopamine (DA), norepinephrine (NA) and serotonin (5-HT) may affect the ability for women to have positive sexual desire (libido) and have satisfying sexual events. In the prefrontal cortex, serotonin may be at increased amounts while norepinephrine and dopamine may be at decreased levels. Flibanserin has activity on serotonin receptors (5-HT1A and 5-HT2A). This activity leads to elevated NE and DA levels and reduced serotonin levels within the prefrontal cortex intracellularly. The drug may also have activity on 5-HT2B, 5-HT2C, and DA D4 receptors. The drug has not been found to be addictive or lead to misuse.
Melatonin3-5
Melatonin production is generated from the conversion of tryptophan. Tryptophan is converted to serotonin and then subsequently to melatonin. The neurohormone is synthesized and secreted in the pineal gland. The suprachiasmatic nucleus in the hypothalamus maintains the circadian rhythms in the body including rest and activity from photic input. Synthesis and secretion of melatonin is activated by darkness and decreased via light. During jet lag or circadian rhythm disorders endogenous melatonin is not secreted. Administering exogenous melatonin helps to reset behavioral sleep patterns. It may also facilitate sleep.
Common2
Flibanserin
Melatonin3
Adverse effects that have been reported with pharmacologic therapies in this category may include dizziness, somnolence, fatigue, nausea, dry mouth, and hypotension. Syncope has been reported in rare cases. Most adverse effects are mild to moderate and may improve with continued use or dose adjustment under medical supervision.
Contraindications2
Known hypersensitivity or intolerance to Flibanserin or Melatonin
Precautions2
Contraindications & Safety Information
Contraindications WellsYI, a compounded preparation, should not be used in patients with known hypersensitivity to any component of the formulation. Use is contraindicated in patients with hepatic impairment due to increased risk of adverse effects. Concomitant use with strong or moderate CYP3A4 inhibitors may significantly increase systemic exposure and risk of adverse reactions. Alcohol use may increase the risk of hypotension and syncope and should be avoided.
Warnings & Precautions Use caution in patients with a history of hypotension, cardiovascular conditions, or those taking medications that may lower blood pressure or cause CNS depression. Patients should be counseled on the potential for dizziness, somnolence, and impaired alertness, particularly when initiating therapy or adjusting dose.
This information is for educational purposes only. This compounded product has not been reviewed, approved, or evaluated by the Food and Drug Administration for safety and effectiveness. This product is not intended to diagnose, treat, cure, or prevent any disease. No claims are made regarding treatment, cure, or prevention of any disease or condition.
This information may not cover all possible drug information about this product. Call your doctor for medical advice and/or about side effects. You may report side effects to the FDA at 1-800-FDA-1088. A Wells Pharmacy Network pharmacist will be happy to answer any questions. For consultation, please call 1-800-622-4510.
Clinical Use: This compounded preparation has not been evaluated or approved by the FDA for safety or effectiveness. Therapy should be prescribed only after appropriate patient evaluation and individualized risk-benefit assessment by a licensed healthcare provider.
