Can Armodafinil Cause Tinnitus?
Tinnitus is not listed among the commonly reported adverse events associated with armodafinil use based on current clinical evidence and guidelines.
Documented Adverse Event Profile
According to the American Academy of Sleep Medicine's comprehensive 2021 clinical practice guideline, the commonly reported adverse events with armodafinil across all studies include 1:
- Headache - most frequently reported
- Upper respiratory tract infections
- Dizziness
- Nausea
- Sinusitis
- Somnolence (paradoxically)
Additional adverse events documented in clinical trials include 2:
- Insomnia
- Anxiety
Absence of Tinnitus in Clinical Evidence
The systematic review of armodafinil studies across multiple indications (narcolepsy, obstructive sleep apnea, shift work disorder, traumatic brain injury, and dementia with Lewy bodies) does not identify tinnitus as a recognized adverse event 1. This is notable given that these guidelines synthesized data from randomized controlled trials and observational studies involving hundreds of patients treated with armodafinil doses ranging from 150-250 mg daily 3, 2.
Clinical Interpretation
While the absence of tinnitus from reported adverse events suggests it is not a common or recognized side effect of armodafinil, this does not definitively exclude the possibility of rare or idiosyncratic reactions. However, based on the available high-quality guideline evidence and clinical trial data, tinnitus should not be considered an expected adverse effect of armodafinil therapy 1.
Important Safety Considerations
When prescribing armodafinil, clinicians should focus monitoring on the documented adverse events, particularly 1, 4: