Approved Cannabinoid Medicines: Epidiolex, Dronabinol, Nabilone and Nabiximols

Approved Cannabinoid Medicines

A few medicines containing a single cannabinoid, or a measured cannabinoid mix, have gone through formal regulatory review. This is very different from cannabis flower or store-bought CBD. The FDA says it has not approved a marketing application for cannabis for any disease or condition, but has approved one cannabis-derived and three cannabis-related drug products, available only by prescription. [1] NIDA likewise says no product made from whole cannabis plant material is FDA-approved for any purpose. [2]

The evidence label approved medicine means a regulator reviewed trials for a stated use. It does not mean the product suits everyone. This page describes labels and does not give dosing or advice to start or stop anything; talk with the prescriber.

Approval status, brand availability and rules change; this is not a complete list of countries.

Epidiolex and Epidyolex (cannabidiol)

The FDA approved Epidiolex in 2018, and the EU authorized Epidyolex on 19 September 2019. [9][4] The US label covers seizures with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex in patients 1 year and older. [3] In the EU it is used alongside clobazam for the first two, and with other epilepsy treatments for tuberous sclerosis complex, from age two. [4]

The EMA reported reductions in drop seizures of up to 64% with Epidyolex plus clobazam compared with up to 31% on placebo plus clobazam. [4] These figures come from trials in people with these rare syndromes, not from the general public or the wider epilepsy population.

Warnings on the labels matter, because they show what CBD can do at medicine strengths:

• Liver. The US label says Epidiolex can cause dose-related rises in liver enzymes. [3] The EMA says the liver risk can be managed with restrictions and regular monitoring. [4] Most of the enzyme rises in controlled studies occurred in people also taking valproate, and clobazam also raised the rate. [3]
• Sleepiness. Somnolence and sedation affected 32% of Epidiolex-treated patients in studies, versus 11% on placebo. [3]
• Mood. Epilepsy medicines as a group raise the risk of suicidal thoughts or behavior. [3]
• Common effects. Sleepiness, decreased appetite, diarrhea, liver enzyme rises, tiredness, rash, sleep problems and infections. [3]

In England, NICE recommends cannabidiol with clobazam for Lennox-Gastaut syndrome in people aged two and older, and says it should be stopped if seizure frequency has not fallen by at least 30% compared with the six months before starting. [10] More on the research is in cannabinoids and neurological conditions.

Dronabinol (Marinol, Syndros)

Dronabinol is synthetic delta-9 THC. [1] The US labels list two adult uses: appetite loss with weight loss in AIDS, and chemotherapy nausea and vomiting in patients who did not respond adequately to usual anti-sickness treatment. [5][6]

Label cautions include mental effects. The Syndros label says dronabinol has been reported to worsen mania, depression or schizophrenia. [5] The capsules are contraindicated in people with a history of hypersensitivity to dronabinol or sesame oil. [6]

Evidence: NCCIH says reviews found dronabinol and nabilone more helpful than placebo for chemotherapy nausea and similar to other medicines, but most of that research was done in the 1980s and 1990s. [8] For HIV-related appetite, it calls the evidence limited. [8]

Nabilone (Cesamet)

Nabilone is a synthetic cannabinoid with a structure similar to THC. [1] We could not read the current US prescribing label this session, so we do not list its warnings. In England, NICE says to consider nabilone as an add-on for adults whose chemotherapy nausea persists despite optimized usual medicines. [10] NICE also says not to offer nabilone for chronic pain. [10]

Nabiximols (Sativex)

Nabiximols is a cannabis-based spray used in the mouth. [7] NHS describes it as licensed in the UK for adults with MS-related spasticity that has not improved with other treatments. [7] NICE advises a 4-week trial in eligible adults with moderate to severe MS spasticity. [10] NCCIH noted in 2019 that it was approved in more than 25 countries outside the United States. [8] We did not verify other countries from their regulators.

What is not approved

Cannabis plant material, over-the-counter CBD and delta-8 products are not approved medicines. [1][11] In England, the NHS says very few people are likely to get an NHS prescription for medical cannabis. [7] See cannabis and CBD laws by country, CBD (cannabidiol), THC and medication interactions.

Laws change and this page is not legal advice.