Pitolisant (Wakix)
Cognitive · H3 receptor inverse agonist
Tier B+
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.
Typical use: 17. — Rx.
What this is
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
Dose & route
17.8-35.6 mg PO once daily morning
Citations
- https://pubmed.ncbi.nlm.nih.gov/41233821/
- https://pubmed.ncbi.nlm.nih.gov/29475822/
- https://pubmed.ncbi.nlm.nih.gov/31230167/
- https://clinicaltrials.gov/study/NCT05223166
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Common questions
- Does Pitolisant (Wakix) work?
- 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.
- Is Pitolisant (Wakix) safe?
- Pitolisant (Wakix) has a low-med risk profile in published human data. Legal status: Rx (NOT scheduled — unique among wakefulness drugs). This is not medical advice — see the disclaimer.
- What is the typical dose for Pitolisant (Wakix)?
- 17.8-35.6 mg PO once daily morning
- 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.