Ganaxolone

A neuroactive steroid anticonvulsant (GABA-A modulator), FDA-approved for seizures of CDKL5 deficiency disorder in patients 2 years and older.

psilodex.org/m/ganaxolone · data v2026.10.05

Clinical contraindication: None listed; No label contraindication covering psilocybin was found. This is not a finding that the combination has been shown to be without risk.
Psilocybin evidence: No psilocybin data
Half-life: ~34 h; Approximate, in adults. Source under Interaction below.

Named in state rules?

Not namedColorado Condition rules (3)

Not namedOregon

PendingNew Mexico

Cite asPsilodex, “Ganaxolone”, v2026.10.05. psilodex.org/m/ganaxolone

Clinical data and state rules are separate facts. Both are shown; neither is a decision.

What it is used for

FDA status

FDA-approved

FDA-approved for

Seizures of CDKL5 deficiency disorder (age 2 and older)

Sources [1]

01 Interaction with psilocybin

Its effect on psilocybin is unknown; it causes sleepiness and sedation. Stopping it suddenly after regular use can cause seizures.

Detail There are no psilocybin data. Ganaxolone boosts GABA-A receptors (the brain's calming system). Its label lists sleepiness and sedation, which other CNS depressants (sedating drugs) can add to. Any effect on psilocybin's effects is unknown. Also, its label carries the suicidality warning given for all antiepileptic drugs and notes seizure risk on abrupt withdrawal. Sources [1]

Human data with psilocybin: No psilocybin data; based on how it works and its label
Half-life: ~34 h (FDA label, checked 2026-10-04)

Evidence types on this record

No psilocybin dataNo psilocybin data: no human data with psilocybin or another classic psychedelic; the text draws on the medication's own pharmacology and its label or reference facts

02 Pharmacology relevant to psilocybin

3 listed · counted on reports

Sedating or CNS depressant: Slows the central nervous system: drowsiness, slower reactions and impaired coordination, and slowed breathing at high doses. Effects add with other sedating substances. Sources [1]
Withdrawal or rebound if stopped abruptly: Stopping suddenly can cause withdrawal or a rebound of symptoms. Sources [1]
Psychiatric reactions: The label or source warns of psychiatric effects such as psychosis, mania, hallucinations, suicidal thoughts or severe mood or behavior changes. Psilocybin can also bring up strong emotions, so these warnings are relevant to screening. Sources [1]

03 State rules

Plain-language summary · official text governs

CO4 CCR 755-1

Not namedCondition rules (3)

No provision names this medication or its class.

Colorado · checked 2026-10-04

OROAR 333-333

Not named

No provision names this medication or its class.

Oregon · checked 2026-10-04

NM7.35.3 NMAC (proposed)

Pending

New Mexico's clinical rules (proposed 7.35.3 NMAC) are not final. No provision naming this medication has been found.

New Mexico · checked 2026-10-04

04 Conditions to ask about

Screening items in state rules

This medication is usually taken for a condition. State rules screen for some conditions directly, so the medication is a prompt to ask about them. Confirm with the participant; never assume a condition from the medication.

Seizure disorder (usual indication)
- CO 2.5(A)(2) · Clinical Facilitator licensees
- CO 6.16(F)(2)(a) · Facilitators without a clinical facilitator license
- CO 6.16(F)(1) · All licensees

05 Sources

ZTALMY (ganaxolone) oral suspension · FDA label (DailyMed) — revised 2026-09 | Sedating or CNS depressant: 5.1 Somnolence and Sedation "ZTALMY can cause somnolence and sedation." | Psychiatric reactions: 5.2 Suicidal Behavior and Ideation "Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication." | Withdrawal or rebound if stopped abruptly: 5.3 Withdrawal of Antiepileptic Drugs "ZTALMY should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus" | 12.3 Pharmacokinetics "The terminal half-life for ganaxolone is 34 hours."

Record history

v2026.10.02First published.
2026-10-04Last reviewed against its sources.

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