Rankings / Cognitive

Pitolisant (Wakix)

Cognitive · H3 receptor inverse agonist

Tier B+

Reviewed by Read Off Label · Last reviewed · How we grade

prescription
7.4 / 10
Tier B+
Ev 8 Bn 6.5 Sf 7

Bottom line

Read Off Label grades Pitolisant (Wakix) as B+ (7.4/10) based on strong evidence, moderate-strong benefit magnitude, and a low-med-risk safety profile.

Harmony Biosciences; brand Wakix.

Studied, labeled, or reported-use context: 17. — Rx; not individualized guidance.

What the evidence says

Harmony Biosciences; brand Wakix. FDA-approved 2019 for narcolepsy. The non-controlled status is the key differentiator — uniquely accessible without DEA scheduling concerns. Clinical effect somewhat smaller than modafinil/solriamfetol but unique mechanism makes it complementary rather than redundant.

Mechanism

Histamine H3 receptor inverse agonist/antagonist — increases endogenous histamine release in tuberomammillary nucleus → cortical wakefulness; non-controlled, non-amphetamine mechanism

Studied, labeled, or reported dose & route

17.8-35.6 mg PO once daily morning

This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.

Citations

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Common questions

What does the evidence show about Pitolisant (Wakix)'s effects?
Read Off Label rates the evidence for Pitolisant (Wakix) as Strong and the benefit magnitude as moderate-strong, producing an overall grade of B+ (7.4/10). Harmony Biosciences; brand Wakix.
What safety findings are reported for Pitolisant (Wakix)?
Pitolisant (Wakix) has a low-med risk profile in the database. Low-Med (headache, insomnia, nausea, anxiety; QT prolongation requires baseline ECG; not Schedule classed) Legal status: Rx (NOT scheduled — unique among wakefulness drugs).
What doses or routes are reported for Pitolisant (Wakix)?
17.8-35.6 mg PO once daily morning This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
How does Pitolisant (Wakix) work?
Histamine H3 receptor inverse agonist/antagonist — increases endogenous histamine release in tuberomammillary nucleus → cortical wakefulness; non-controlled, non-amphetamine mechanism

This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.