Nabilone Indications
Nabilone is FDA-approved specifically for breakthrough and refractory chemotherapy-induced nausea and vomiting (CINV) that has failed conventional antiemetic therapy, and should be considered a second-line or rescue agent rather than first-line treatment. 1
Primary FDA-Approved Indication
Chemotherapy-Induced Nausea and Vomiting (CINV)
ASCO guidelines recommend nabilone (or dronabinol) specifically for rescue and refractory CINV when first-line antiemetics have failed, with moderate certainty of evidence. 2, 1
Nabilone should NOT be used as first-line prophylaxis for CINV—standard regimens with 5-HT3 antagonists, NK1 antagonists, and dexamethasone remain the primary approach for moderate and high-emetogenic chemotherapy. 2
Historical trials from the 1970s-1980s showed nabilone superior to prochlorperazine, with 70-80% of patients responding versus only 32% with prochlorperazine, though complete symptom relief occurred in only 8% of patients. 3, 4
Nabilone demonstrated effectiveness in reducing both nausea severity and vomiting frequency compared to prochlorperazine, with patients clearly preferring nabilone despite higher side effect rates. 5, 3
Off-Label Considerations with Limited Evidence
Sleep Disturbances in Cancer Pain
ASCO guidelines rate nabilone with moderate certainty of evidence for improving sleep specifically in patients with chronic cancer pain, representing a potential secondary benefit rather than primary indication. 1
This indication is limited to sleep disturbances related to chronic pain conditions, not insomnia as a standalone diagnosis. 1
NOT Recommended Indications
Nabilone is NOT recommended for appetite stimulation or cachexia as a primary indication, with low certainty evidence showing no benefit on weight or appetite outcomes. 2, 1
Insufficient evidence exists to recommend nabilone for anxiety, depression, or quality of life as primary outcomes (very low to low certainty evidence). 1
ASCO states evidence is insufficient to recommend nabilone for nausea and vomiting unrelated to chemotherapy, or for prevention of radiotherapy-induced nausea and vomiting. 2
Nabilone is not recommended for cancer pain management—meta-analyses showed no statistically significant benefit for cancer pain, though some benefit exists for neuropathic pain in non-cancer contexts. 2, 6
Dosing and Administration
Standard dosing is 1-2 mg orally twice daily, starting 1-12 hours before chemotherapy and continuing throughout the treatment duration. 5, 7
Doses higher than 1 mg twice daily showed no additional benefit and increased side effects in gastrointestinal dysmotility studies. 7
Critical Safety Considerations
Side effects occur in 60-70% of patients, including drowsiness, dizziness, vertigo, dry mouth, and postural hypotension. 5, 3
Serious adverse effects requiring medical attention occur in approximately 3-7% of patients, including hallucinations, toxic psychoses, severe hypotension, and ataxia. 5, 4
Euphoria is relatively uncommon (14-16%) and typically mild, though unpredictability of neuropsychiatric effects warrants caution. 3, 4
Despite higher side effect rates compared to conventional antiemetics, most patients prefer nabilone for symptom control and side effects rarely lead to drug withdrawal. 5, 3
Clinical Pitfalls to Avoid
Do not use nabilone as first-line antiemetic therapy—it is reserved for refractory cases after guideline-consistent regimens have failed. 2, 1
Medical marijuana cannot be substituted for FDA-approved nabilone due to lack of precisely defined doses and schedules, with insufficient evidence supporting this substitution. 2
Nabilone does not add benefit when combined with 5-HT3 receptor antagonists in controlled studies, so reserve it for true breakthrough situations. 6
Monitor for postural hypotension, particularly on day 1 of treatment, as erect systolic blood pressure may be significantly lower. 4