Current label evidence
Fatigue occurred more often with labeled Vyleesi than with placebo
The current Vyleesi prescribing information reports fatigue in 3.2% of treated patients and 0.5% of placebo-treated patients in pooled phase 3 controlled trials. The label does not publish a fatigue-specific median onset or duration and does not identify fatigue among the adverse reactions occurring in more than 4% of treated patients. These group-level findings support taking the symptom seriously without predicting how long an individual episode should last or proving that the medication is the cause.
- Do not transfer the label’s nausea timing to fatigue; nausea has separate onset and duration data, while fatigue does not have a label-based countdown.
- A clinician should consider other causes such as poor sleep, sleep apnea, illness, dehydration, low intake, anemia, pregnancy, thyroid or glucose problems, mood symptoms, medication effects, alcohol or other substances, and cardiovascular or neurologic illness.
- Do not use a trial percentage as permission to continue after severe, persistent, recurrent, unfamiliar, or treatment-limiting tiredness.