Nabilone

Evidence Level: L4

Predicted Indications: 9

Nabilone

Pharmacist Assessment Report

Nabilone: From Chemotherapy-Induced Nausea and Vomiting to Migraine Disorder

One-Sentence Summary

Nabilone is a synthetic cannabinoid that is marketed in Canada. The data compiled for this report do not include its approved indication text. The TxGNN model predicts it may be effective for migraine disorder, but no clinical trials are registered for that indication. Only 1 systematic review supports it directly, and that review is class-level evidence. The closest direct evidence is a small 2012 trial in the related condition of headache disorder (medication overuse headache).

Quick Overview

Item	Content
Original Indication	Not available in the Canadian licence data compiled for this report (nabilone is known to be approved for chemotherapy-induced vomiting refractory to other antiemetics, per a retrieved publication)
Predicted New Indication	Migraine disorder
TxGNN Prediction Score	0.9989
Evidence Level	L4 (for migraine disorder; the related headache disorder entry reaches L3)
Canada Market Status	Marketed (marketed DINs: 9 of 9)
Number of DINs	9 (marketed: 9)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the compiled data. Based on known information, nabilone is a synthetic CB1/CB2 cannabinoid receptor agonist, an analogue of delta-9-tetrahydrocannabinol (THC). It is approved for chemotherapy-induced vomiting that does not respond to other antiemetics.

The endocannabinoid system modulates trigeminovascular nociception, CGRP release and central pain processing. Those are pathways involved in migraine. This gives a plausible, though indirect, reason for the prediction.

The supporting evidence is limited. The one item linked to migraine is a 2026 systematic review of cannabinoid interventions for low back pain and migraine. Its title does not show whether nabilone-specific migraine data were included, so the evidence is class-level only. The closest direct evidence is a small 2012 trial of nabilone in medication overuse headache, listed under the broader headache disorder prediction.

Clinical Trial Evidence

Currently no related clinical trials registered for migraine disorder. No trials are registered for the other predicted headache-related indications either.

Literature Evidence

Migraine disorder

PMID	Year	Type	Journal	Key Findings
42773786	2026	Systematic Review	Cannabis and Cannabinoid Research	Reviews RCTs of isolated cannabinoids, synthetic cannabinoids, vaporized cannabis and standardized extracts for low back pain, migraine and medication-overuse headache. The abstract notes uncertainty about indication-specific value.

Related headache evidence (predicted indication rank 3: headache disorder)

PMID	Year	Type	Journal	Key Findings
23070400	2012	Preliminary double-blind, active-controlled randomized trial	J Headache Pain	30 patients with long-standing intractable medication overuse headache. The study evaluated nabilone for pain, headache frequency, analgesic intake and quality of life.
28281107	2017	Review	Curr Pain Headache Rep	Primer on cannabis for pain and headaches. It describes the endocannabinoid system as a basis for further research.

Canada Market Information

DIN	Product Name	Dosage Form	Approved Indication
02256193	CESAMET	Not listed	Not listed
00548375	CESAMET	Not listed	Not listed
02312263	CESAMET	Not listed	Not listed
02380897	PMS-NABILONE	Not listed	Not listed
02384892	TEVA-NABILONE	Not listed	Not listed

All 9 licences are valid single-ingredient products. The list above shows 5 of them. The others are PMS-NABILONE and TEVA-NABILONE products.

Safety Considerations

Package insert warnings and contraindications were not available in the compiled data. Please refer to the package insert for these.

Contraindication signals from the knowledge graph (drug-disease links in the TxGNN knowledge graph, not label text):
- Psychiatric: psychotic disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, mental disorder, anxiety disorder, neurotic disorder, dysthymic disorder
- Substance use: substance-related disorder, substance abuse/dependence
- Cardiovascular: hypertension and hypertensive disorder, hypotensive disorder, coronary artery disease, sudden cardiac arrest, heart conduction disease
- Liver: liver failure
Drug interactions: The interaction search returned 100 records. All 20 reviewed were rated Moderate. They include:
- CNS depressants and opioids: fentanyl, alfentanil, codeine, dihydrocodeine, tramadol, alprazolam, amobarbital, ethanol
- Sedating antihistamines: chlorpheniramine, cetirizine, phenyltoloxamine
- Antidepressants: amitriptyline
- Blood pressure agents: nifedipine, amlodipine, acebutolol, alfuzosin, amiloride, hydrochlorothiazide
- Other: aldesleukin, dichloralphenazone

The psychiatric and cardiovascular signals matter for migraine patients. Many have comorbid anxiety or depression and may take blood pressure or sedating medicines.

Conclusion and Next Steps

Decision: Hold

Rationale:

The migraine prediction has a high model score (0.9989) and a plausible mechanism, but no registered trials and only class-level literature. The only direct nabilone evidence is a small preliminary trial in medication overuse headache, a related but different condition.
The knowledge-graph contraindication signals (psychiatric, cardiovascular) and the missing label safety data add to the case for waiting.
Other predictions are weaker. Several (atrophoderma vermiculata, nephrogenic syndrome of inappropriate antidiuresis, ulerythema ophryogenesis) have no plausible mechanism and are likely TxGNN model (deep learning) artifacts.

To proceed, the following is needed:

Confirm whether the 2026 systematic review includes nabilone-specific migraine data, and extract the effect sizes.
Search for nabilone-specific migraine studies, and consider a small proof-of-concept trial.
Obtain the Health Canada package insert (warnings, contraindications, approved indication, dosage form) for each licence.
Obtain detailed mechanism of action data from DrugBank.
Define a safety plan for patients with psychiatric, cardiovascular or substance-use comorbidity, and for those taking sedating medicines.
Clarify whether the 2012 medication overuse headache trial can support a headache-focused development path.
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.