Pitolisant
Brand names: Wakix, Ozawade
Pitolisant is an oral histamine H3-receptor antagonist/inverse agonist used to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.
ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.
Clinical monograph
How it works
By blocking presynaptic H3 autoreceptors it increases the synthesis and release of histamine and other wake-promoting neurotransmitters in the brain, enhancing wakefulness.
Prescribing in practice
- It can prolong the QT interval, so caution and ECG consideration are needed with cardiac disease, electrolyte disturbance, or other QT-prolonging drugs.
- It is taken once daily in the morning and titrated upward, with dose adjustment required in hepatic and renal impairment.
- It may reduce the effectiveness of hormonal contraceptives, so an alternative method should be used during and for some weeks after treatment.
Monitoring
Monitor for QT prolongation where risk factors exist, along with insomnia, anxiety, headache and gastrointestinal effects.
Counselling the patient
- Take it once a day in the morning to avoid disturbing your sleep.
- Use a reliable non-hormonal contraceptive method, as it can stop the pill working.
- Report palpitations, fainting, or persistent anxiety to your team.
Evidence & guidelines
The HARMONY trials demonstrated reductions in daytime sleepiness and cataplexy, and NICE recommends it as an option for narcolepsy with or without cataplexy.
Reference: NICE TA665/TA766; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
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- Adult Head Injury · NICE NG232 (2023)
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