DEA schedule
Is Wakix a controlled substance?
Wakix contains pitolisant. Federal schedule from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Wakix (pitolisant) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and pitolisant is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 2 prescription listings from 1 labelers, none with a DEA schedule |
| DEA controlled substances list | pitolisant is not on the list |
Wakix NDC listings
Questions
Is Wakix a controlled substance?
No. Wakix (pitolisant) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and pitolisant is not on the DEA controlled substances list.
Is Wakix a narcotic?
No. Wakix (pitolisant) is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Histamine-3 Receptor Antagonist/Inverse Agonist.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.