Causality assessment · Contested: signal not confirmed by large randomized trials

Modafinil and Suicidal ideation: is the FAERS signal real?

n=654 co-reports · PRR 4.7 · ROR 4.8

Modafinil side-effect profile All assessments See in the full list

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Contested: signal not confirmed by large randomized trials

Modafinil ↔ Suicidal ideation

n=654 co-reports · PRR 4.7 · ROR 4.8

Modafinil is a wakefulness-promoting agent; suicidal ideation appears in this dataset at 654 co-reports (PRR 4.7), and the label carries a warning to monitor for psychiatric symptoms. The association is difficult to interpret, however: modafinil is used in narcolepsy and obstructive sleep apnoea, conditions associated with depressed mood and reduced quality of life, and it is also used off-label in depression, so confounding by indication is substantial and the causal contribution of the drug is uncertain.

Regulatory basis: modafinil (Provigil) prescribing information — psychiatric-symptom monitoring; FDA 2007 alert on serious skin reactions.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	partial	Psychiatric symptoms can appear on treatment
Strength	met	PRR 4.7, moderate
Consistency	not established	Not consistently reproduced
Specificity	not established	Cannot separate drug from the treated disorder
Biological gradient	not established	No established dose relationship
Plausibility	partial	Plausible via altered wakefulness/mood
Coherence	not established	Confounded by indication
Experiment	n/a	Not a trial endpoint
Analogy	partial	Debated analogy to stimulants

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (NCT01072929)

Adverse event	ARMODAFINIL 150 MG (n=198) · ARMODAFINIL 200 MG (n=32) · PLACEBO (n=199)
Suicidal ideation	2/198	0/32	0/199
Suicide attempt	0/198	0/32	1/199

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →