Flibanserin Discontinuation
No, flibanserin does not need to be tapered and can be discontinued abruptly without risk of withdrawal symptoms.
Rationale for Abrupt Discontinuation
- The FDA prescribing information for flibanserin (Addyi) contains no warnings or recommendations regarding tapering when discontinuing the medication 1
- Unlike medications that affect serotonin-norepinephrine reuptake (such as SNRIs) or benzodiazepines, flibanserin's mechanism as a 5-HT1A agonist/5-HT2A antagonist does not produce a discontinuation syndrome requiring gradual dose reduction 2, 3
- Clinical trials of flibanserin lasting 24-28 weeks showed no reports of withdrawal symptoms or discontinuation syndromes when treatment was stopped 2, 4, 5
Key Differences from Medications Requiring Tapering
- SNRIs and antidepressants (duloxetine, venlafaxine) require tapering to prevent discontinuation syndrome characterized by adrenergic hyperactivity, as these medications directly affect serotonin and norepinephrine reuptake 6
- Benzodiazepines require slow tapering over months to prevent serious withdrawal including seizures, rebound anxiety, and potentially death 7
- Flibanserin, in contrast, acts through a different mechanism and has demonstrated no such withdrawal phenomena in clinical studies 1, 2, 4
Clinical Considerations at Discontinuation
- Symptom recurrence: Patients should be counseled that their HSDD symptoms (low sexual desire and associated distress) will likely return after stopping flibanserin, as this represents the underlying condition rather than a withdrawal effect 2, 5
- Timing of discontinuation: The FDA label recommends discontinuing treatment after 8 weeks if no improvement is observed, with no mention of tapering requirements 1
- Safety profile: The most common adverse events during treatment (dizziness, somnolence, nausea) resolve after discontinuation without requiring gradual dose reduction 2, 4
Documentation and Patient Education
- Document the reason for discontinuation in the medical record 8
- Inform patients that their overactive sexual desire symptoms may return, but this is not a withdrawal syndrome 8
- No special monitoring is required after abrupt discontinuation, unlike medications requiring tapering 1
Common Pitfalls to Avoid
- Do not confuse the return of HSDD symptoms with withdrawal—this represents the natural course of the untreated condition rather than medication discontinuation effects 2
- Do not apply tapering protocols used for antidepressants or benzodiazepines to flibanserin, as the pharmacology and clinical profile are fundamentally different 6, 7, 1
- Avoid unnecessary delays in discontinuation if the medication is ineffective after 8 weeks or if contraindications develop (such as need for CYP3A4 inhibitors or development of hepatic impairment) 1