Nabilone

Mechanism-of-action class: Cannabinoid Receptor Agonists.

• Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.ICD-10: R11.2

• Cesamet is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.contraindicated

The usual adult dosage is 1 or 2 mg 2 times a day. On the day of chemotherapy, the initial dose should be given 1 to 3 hours before the chemotherapeutic agent is administered. To minimize side effects, it is recommended that the lower starting dose be used and that the dose be increased as necessary. A dose of 1 or 2 mg the night before may be useful. The maximum recommended daily dose is 6 mg given in divided doses 3 times a day. Cesamet may be administered 2 or 3 times a day during the entire course of each cycle of chemotherapy and, if needed, for 48 hours after the last dose of each cycle of chemotherapy.

• The effects of Cesamet may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment. • Cesamet has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria “high”, ataxia, anxiety, disorientation, depression, hallucinations and psychosis. • Cesamet can cause tachycardia and orthostatic hypotension. • Because of individual variation in response and tolerance to the effects of Cesamet, patients should remain under supervision of a responsible adult especially during initial use of Cesamet and during dose adjustments. • Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet. • Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.

Commonly Encountered Reactions: During controlled clinical trials of Cesamet, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria (feeling “high”), ataxia, headache, and concentration difficulties. Comparative Incidence of Reactions: Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by factors such as drug dose, detection technique, setting, and physician judgments, among others. Consequently, the tables presented below are presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of Cesamet under relatively similar conditions of use. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice, in which patient characteristics and other factors may differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products because each group of drug trials is conducted under a different set of conditions. Finally, it is important to emphasize that these tabulations do not reflect the relative severity and/or clinical importance of the adverse events. A better perspective on the serious adverse events associated with the use of Cesamet is provided in the WARNINGS and PRECAUTIONS sections.

Metabolism

Absorption and Distribution: Cesamet (nabilone) appears to be completely absorbed from the human gastrointestinal tract when administered orally. Following oral administration of a 2 mg dose of radiolabeled nabilone, peak plasma concentrations of approximately 2 ng/mL nabilone and 10 ng equivalents/mL total radioactivity are achieved within 2.0 hours.

Signs and Symptoms —Signs and symptoms of overdosage are an extension of the psychotomimetic and physiologic effects of Cesamet. Treatment —To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Overdosage may be considered to have occurred, even at prescribed dosages, if disturbing psychiatric symptoms are present. In these cases, the patient should be observed in a quiet environment and supportive measures, including reassurance, should be used. Subsequent doses should be withheld until patients have returned to their baseline mental status; routine dosing may then be resumed if clinically indicated. In such instances, a lower initiating dose is suggested. In controlled clinical trials, alterations in mental status related to the use of Cesamet resolved within 72 hours without specific medical therapy.

• Dec 26, 1985NDANDA018677Bausch

1. 1Pain47524%
2. 2Drug Ineffective36518%
3. 3Off Label Use35418%
4. 4Musculoskeletal Stiffness28514%
5. 5Insomnia26513%
6. 6Rheumatoid Arthritis26513%
7. 7Drug Hypersensitivity25613%
8. 8Gait Disturbance24512%
9. 9Nausea23212%
10. 10Fatigue22511%
11. 11Arthralgia22311%
12. 12Diarrhoea1979.9%
13. 13White Blood Cell Count Abnormal1939.7%
14. 14Malaise1819.1%
15. 15Headache1799.0%

The 10 most recently updated of 35 ClinicalTrials.gov registrations naming Nabilone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
  Recruiting · Phase 3 · Interventional · 420 enrolled · PleoPharma, Inc.
  NCT07644052updated 2026-06-12
• The Role of Endocannabinoids in Insulin Production and Action
  Completed · Phase 1 · Interventional · 45 enrolled · National Institute on Aging (NIA)
  NCT01517100updated 2026-06-01
• A Pilot Trial of Nabilone for the Treatment of Obesity
  Terminated · Phase 2 · Interventional · 18 enrolled · Centre for Addiction and Mental Health
  NCT04801641updated 2026-04-09
• Investigating the Effects of Nabilone on Endocannabinoid Metabolism
  Completed · Phase 4 · Interventional · 10 enrolled · Centre for Addiction and Mental Health
  NCT05885685updated 2026-03-11
• Nabilone for Agitation Blinded Intervention Trial
  Recruiting · Phase 3 · Interventional · 112 enrolled · Sunnybrook Health Sciences Centre
  NCT04516057updated 2026-01-28
• Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities
  Completed · Phase 1 · Interventional · 20 enrolled · Hsiang-Yuan Lin
  NCT05273320updated 2026-01-23
• Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury
  Completed · Phase 3 · Interventional · 14 enrolled · Eldon Loh, MD
  NCT04057456updated 2025-07-22
• Nabilone for Agitation in Frontotemporal Dementia
  Recruiting · Phase 2 · Interventional · 45 enrolled · Simon Ducharme, MD
  NCT05742698updated 2025-04-15
• Effect of PP-01 on Cannabis Withdrawal Syndrome
  Completed · Phase 2 · Interventional · 234 enrolled · PleoPharma, Inc.
  NCT05494437updated 2024-08-16
• Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder
  Withdrawn · Phase 1 · Phase 2 · Interventional · 0 enrolled · New York State Psychiatric Institute
  NCT04880278updated 2024-05-21

Frequently asked questions

How does Nabilone work?

Mechanism-of-action class: Cannabinoid Receptor Agonists.

What is Nabilone used for?

According to FDA labeling, Nabilone carries indications including: Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nabilone?

Nabilone is classified as Other antiemetics, Cannabinoid, Cannabinoid Receptor Agonists, Decreased Central Nervous System Organized Electrical Activity, Emesis Suppression.

What are the brand names for Nabilone?

Nabilone is marketed under brand names including Cesamet.

What are the contraindications for Nabilone?

Nabilone labeling lists contraindications including: Cesamet is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.. Always consult the full prescribing information and a clinician.