Can Flibanserin (Addyi) be safely sold by a pharmacy like Mercury Drug?

Flibanserin Distribution Through Retail Pharmacies

Flibanserin (Addyi) can be legally sold by retail pharmacies like Mercury Drug, but only through FDA-mandated restricted distribution programs that require specific prescriber and pharmacy certification due to serious risks of hypotension and syncope, particularly when combined with alcohol. 1

Regulatory Requirements for Pharmacy Distribution

Risk Evaluation and Mitigation Strategy (REMS) Program

• The FDA requires flibanserin to be dispensed only through certified pharmacies enrolled in the REMS program due to boxed warnings about hypotension and syncope risks 1, 2
• Pharmacies must complete certification training and agree to comply with REMS requirements before dispensing flibanserin 1
• The REMS program was implemented specifically because of increased risks when flibanserin is combined with alcohol, based on alcohol challenge study results 3

Prescriber Requirements

• Only certified healthcare providers who have completed REMS training can prescribe flibanserin 1
• Prescribers must counsel patients about the absolute contraindication with alcohol use 1

Safety Profile Relevant to Pharmacy Dispensing

Critical Safety Warnings

• Flibanserin carries a boxed warning for hypotension and syncope, particularly in combination with alcohol 1, 3
• Central nervous system depression is a significant concern, with common adverse events including dizziness (6.4-6.9%), somnolence (6.9-7.7%), and fatigue 3, 4
• Nausea and insomnia are also frequently reported (7.7% insomnia rate) 4

Drug Interactions Requiring Pharmacy Screening

• Strong and moderate CYP3A4 inhibitors are contraindicated with flibanserin due to increased hypotension and syncope risk 1
• Concomitant use with other CNS depressants increases sedation risk 1
• Pharmacists must screen for serotonergic antidepressants, as flibanserin's safety profile is comparable to SSRIs and SNRIs 3

Clinical Context for Pharmacy Counseling

Approved Indication

• Flibanserin is FDA-approved only for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women 1, 5
• The medication is dosed at 100 mg once daily at bedtime 1, 4

Important Patient Populations to Identify

• Flibanserin has NOT been evaluated in women with cancer history or those on endocrine therapy, and the risk/benefit ratio remains uncertain in these populations 6, 7
• The American College of Obstetricians and Gynecologists notes modest efficacy: approximately 1 additional satisfying sexual event every 2 months compared to placebo 7
• Hepatic impairment increases syncope and hypotension risk; flibanserin is contraindicated in hepatic impairment 1

Practical Dispensing Considerations

Mandatory Patient Counseling Points

• Absolute alcohol contraindication: Patients must avoid alcohol from 2 hours before bedtime through the next morning 1
• Bedtime dosing is required to minimize daytime sedation and syncope risk 1, 4
• Patients should be warned about operating machinery or driving, particularly during treatment initiation 1

When to Refuse Dispensing

• Concurrent alcohol use or inability to abstain from alcohol 1
• Active hepatic impairment 1
• Concurrent use of moderate or strong CYP3A4 inhibitors 1
• Prescription from non-REMS certified prescriber 1

Long-term Monitoring Considerations

• Flibanserin may be used for a decade or more in typical premenopausal patients, requiring ongoing pharmacovigilance 2
• The safety profile is comparable to serotonergic antidepressants, with CNS-related adverse events being most common 3
• Efficacy should be reassessed after 8 weeks; discontinue if no improvement 1

Common Pitfalls to Avoid

• Do not dispense without verifying REMS certification for both prescriber and pharmacy 1
• Do not assume patients understand the alcohol contraindication—explicit counseling is mandatory 1
• Do not overlook drug interaction screening for CYP3A4 inhibitors, which are common (e.g., certain antifungals, HIV medications) 1
• Do not dispense to postmenopausal women without confirming off-label use discussion, as FDA approval is only for premenopausal women 1, 5