Index of Herbs

Herbal formula

Sativex (nabiximols)

Also known as Nabiximols, THC:CBD oromucosal spray, delta-9-tetrahydrocannabinol and cannabidiol spray

A prescription mouth spray of two cannabis extracts, about equal THC and CBD, licensed in the UK for MS spasticity after a 4-week trial.

Main use: MS muscle spasticity

Promising clinical evidence

2 ingredients

Updated October 10, 2026

Key points

  1. 01

    Two cannabis extracts, one spray

    Each spray delivers 2.7 mg of THC and 2.5 mg of CBD from two carbon dioxide extracts of cannabis leaf and flower, absorbed through the lining of the mouth.

  2. 02

    Helps some people, not all

    Two early MS trials were weak or negative. A trial that kept only early responders found a clear benefit, so treatment starts with a four-week test.

  3. 03

    Not shown to help pain

    Two phase 3 trials in cancer pain missed their main goals, and NICE advises against cannabis-based medicines, including THC with CBD, for chronic pain.

  4. 04

    Dizziness and mental effects

    Dizziness and tiredness are common early on. Mood changes, hallucinations, and fainting can occur, and it is ruled out with a history of psychosis.

  5. 05

    Interactions and driving

    Ketoconazole raises its levels, enzyme inducers such as St John’s wort lower them, alcohol and sedatives add to its effects, and it can impair driving.

Sativex is a prescription mouth spray made from two extracts of cannabis leaf and flower, obtained with liquid carbon dioxide and combined so that each milliliter contains 27 mg of delta-9-tetrahydrocannabinol (THC) and 25 mg of cannabidiol (CBD). Its international nonproprietary name is nabiximols. Each 100-microliter spray delivers 2.7 mg of THC and 2.5 mg of CBD, along with ethanol, propylene glycol, and peppermint oil. The UK first authorized it on 16 June 2010, and its product information, held by SVX Therapeutics and revised in April 2026, limits it to adults with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medicines and who show a clinically significant improvement during an initial trial. Spasticity is the muscle stiffness and involuntary spasms that many people with MS experience. Treatment must be started and supervised by a doctor with specialist expertise, and the spray is added to existing anti-spasticity medicines rather than replacing them.

Sativex sits between the whole plant and single-molecule drugs. The US Food and Drug Administration (FDA) has approved dronabinol, a synthetic THC, and nabilone, a THC-like synthetic drug, and Epidiolex, which is purified CBD; Sativex is instead a standardized botanical extract with roughly equal amounts of the two main cannabinoids. THC partly activates the CB1 and CB2 cannabinoid receptors, which sit mainly at nerve endings and help regulate the release of signaling chemicals such as glutamate, and in animal models of MS, drugs that activate these receptors eased limb stiffness (product information). Whether the CBD adds to the benefit or softens THC’s side effects has not been shown in the published trials. In healthy volunteers who inhaled THC, Englund and colleagues (Neuropsychopharmacology 2023) found that adding CBD at ratios of 1:1 to 3:1 did not lessen THC’s effects on memory or psychotic symptoms. Sprayed in the mouth, THC is absorbed slowly: four sprays (10.8 mg THC) gave a mean peak of about 4 ng/ml after 45 to 120 minutes, against more than 100 ng/ml within minutes from 8 mg of vaporized THC.

This page covers what is in the spray, the three main MS trials and the “enriched” design that eventually showed a benefit, the negative trials in cancer pain and in children, how the spray is taken, and its safety. The results belong to this product at these doses. They do not transfer to cannabis flower, dispensary oils, or shop CBD products, whose THC and CBD content can differ widely and, according to the National Center for Complementary and Integrative Health (NCCIH), may not match their labels. Sativex is not among the cannabis-derived medicines FDA has approved, and its legal status varies from country to country; its product information advises patients to check before traveling with it. For the plant behind it, and for how THC and CBD differ, see the cannabis monograph. Nothing here is medical advice. People with MS who are considering any cannabis product should talk to their neurology team first.

02 The blend

What’s in it

Ingredients in label order. Results from trials of this formula belong to the combination, not to any single herb in it.

  1. Cannabis leaf and flower extract · Leaf and flower (soft extract)

    38–44 mg per ml

    Cannabis sativa

    One of two extracts made with liquid carbon dioxide. Together the two supply 27 mg of THC and 25 mg of CBD per ml; the product information does not say how the two cannabinoids are split between them.

    Read the cannabis monograph →

  2. Cannabis leaf and flower extract · Leaf and flower (soft extract)

    35–42 mg per ml

    Cannabis sativa

    The second extract. Each 100-microliter spray delivers 2.7 mg of THC and 2.5 mg of CBD, with up to 40 mg of ethanol, 52 mg of propylene glycol, and peppermint oil for flavor.

    Read the cannabis monograph →

03 Evidence

What the research shows

Promising clinical evidence

Our rating for ms muscle spasticity, based on trials of this combination.

The first two phase 3 trials, summarized in the UK product information, were disappointing. In a six-week placebo-controlled trial, Sativex beat placebo on a 0–10 spasticity rating scale, but the difference of 0.5 to 0.6 points was of questionable clinical relevance; in a responder analysis, 40% on Sativex and 22% on placebo improved their score by more than 30%. A second, 14-week phase 3 trial failed to show a significant effect, with a difference of only 0.2 points. The investigators suspected that a useful effect in some people was hidden by others who did not respond at all. Their combined, after-the-fact analyses found that a 19% fall in the spasticity score corresponded to a clinically relevant improvement in how patients rated their overall change, and that a 20% improvement after four weeks predicted an eventual 30% response. That observation shaped both the next trial and the four-week trial rule now used in practice.

Novotna and colleagues (European Journal of Neurology 2011) tested that idea in an enriched-design trial. All 572 people with MS and spasticity resistant to other treatment took Sativex for four weeks without knowing it was active. The 273 who improved by at least 20% were eligible to continue, and 241 were randomized to keep taking Sativex or to switch to placebo for 12 more weeks. Those who continued held their gains (a mean change of −0.19 points), while those switched to placebo got worse (+0.64), a difference of 0.84 points. By week 16, 74% of the Sativex group and 51% of the placebo group had a 30% improvement from the start. Sativex also reduced spasm frequency and sleep disruption from spasticity, and patients, carers, and doctors all rated overall change better. A muscle-tone score (the Modified Ashworth Scale) and a timed 10-meter walk favored Sativex, but those differences were not statistically certain. Because fewer than half of the people who started went on to randomization, the design shows that early responders keep benefiting, not how many people with MS will respond.

Longer-term data are reassuring but limited. In a randomized withdrawal study described in the product information, 36 patients who had used Sativex for an average of 3.6 years were switched to placebo or kept on Sativex for 28 days; treatment failed in 44% of those who continued and 94% of those switched to placebo. The clinical program has included more than 2,000 people with MS, some using up to 48 sprays a day in long-term open studies, far above the licensed maximum of 12. NCCIH cites a 2010 analysis of 666 people in which about a third of those taking nabiximols improved by 30% or more, and a 2014 American Academy of Neurology guideline. In England, the National Institute for Health and Care Excellence (NICE) recommends offering a four-week trial of the THC:CBD spray to adults with moderate to severe MS spasticity when other drugs have not helped, continuing only if spasticity has fallen by at least 20%.

Outside MS spasticity, results have been negative. Fallon and colleagues (British Journal of Pain 2017) ran two phase 3 trials of Sativex in people with advanced cancer whose pain was not controlled by optimized opioid treatment, and neither met its primary goal. The 2026 Cochrane review of cannabis-based medicines for chronic neuropathic pain by Ateş and colleagues found that balanced THC and CBD products increased the proportion of people with moderate pain relief by 7 percentage points, a difference the authors did not consider clinically relevant, while withdrawals for side effects rose. NICE advises that THC with CBD should not be offered to manage chronic pain. In children, a 12-week trial in 72 young people aged 8 to 18 with cerebral palsy or traumatic brain or spinal injury found no significant difference from placebo in spasticity, and the product information does not recommend Sativex under 18.

Sativex is licensed in the UK and, according to NCCIH, has been approved in more than 25 countries, but not in the United States. The research base has clear limits. The trials enrolled people with MS spasticity who had already tried other drugs, so they say nothing about mild spasticity, other neurological conditions, or first-line use. The benefit appears in a subgroup that is identified by trying the drug, and the average improvement in that subgroup, under one point on a 10-point scale against placebo, is modest, although patients who respond often value it, as the global impression ratings suggest. Long-term safety data come mainly from open studies without a comparison group. Finally, no published trial compared Sativex with THC alone or with oral cannabis extracts, so the contribution of its CBD, and of the specific two-extract recipe, remains unknown.

04 In practice

How it is taken

Sativex comes as a 10 ml spray container holding about 90 sprays. Shake it before use and direct each spray at a different place on the lining of the mouth, changing the site each time to reduce soreness. Dosing starts low and rises slowly. On day 1 the patient takes one spray between 4 pm and bedtime; the evening dose rises over the first days, a morning dose is added from day 5, and the total grows by about one spray a day, following a table in the product information, until symptoms are relieved or the maximum of 12 sprays a day is reached, with at least 15 minutes between sprays. Finding the right dose can take up to two weeks, and dizziness is common during this time. The median dose in MS trials was eight sprays a day. Once the dose is settled, the sprays can be spread through the day as suits the person.

Treatment is a trial, not a commitment. A specialist should assess spasticity and the response to standard medicines before starting, and the product information calls for a review after four weeks, stopping if spasticity-related symptoms have not improved by at least 20% on a 0–10 rating scale; NICE uses the same threshold. Long-term benefit should be reassessed periodically. Food changes absorption: taken with food, THC exposure was 2.8 times and CBD exposure 5.1 times higher than when fasting, so the product information advises keeping the timing relative to meals as consistent as possible. The dose may need to be retitrated if other medicines are started or stopped, especially the enzyme inhibitors and inducers listed under safety, or if the MS changes. Elderly people may be more prone to side effects such as dizziness, people with moderate or severe kidney impairment may need lower doses, and use in moderate or severe liver impairment is not advised.

Each spray contains up to 40 mg of alcohol, about 480 mg at the maximum daily dose, which the product information compares to about 10 ml of beer, plus 52 mg of propylene glycol. Unopened containers are stored in a refrigerator, and an opened container should be used within 42 days. Do not spray onto sore or inflamed areas of the mouth, and in long-term use the mouth should be checked regularly; stop and seek advice for persistent soreness or patches. Keep the spray out of children’s reach. Patients should be warned that it may not be legal to take Sativex into some countries and should check before traveling. Driving is covered by specific rules, set out under safety. Sativex is a medicine with a prescription and a supervised trial period; it is not interchangeable with cannabis products bought elsewhere, even those advertised as having a similar THC to CBD ratio.

05 Caution

Before you use Sativex (nabiximols)

Dizziness and fatigue are the most common side effects, mainly in the first four weeks and usually mild to moderate; following the titration schedule reduced them. The product information lists, as common, decreased or increased appetite, depression, disorientation, a feeling of detachment (dissociation), euphoric mood, sleepiness, poor attention or memory, balance problems, blurred vision, vertigo, nausea, diarrhea, dry mouth, constipation, mouth pain and ulcers, and falls. Uncommon effects include hallucinations, paranoia, suicidal thoughts, palpitations, a fast heart rate, high blood pressure, and fainting. Changes in pulse and blood pressure can occur when the dose is first introduced, so caution is needed during titration. Mild stinging at the spray site is common, and two possible cases of leukoplakia, a white patch in the mouth, were seen in trials, though neither was confirmed. In a heart-rhythm study, 18 sprays taken twice a day, far above the licensed maximum, caused short-lived toxic psychosis in 3 of 41 volunteers.

Sativex is contraindicated in anyone allergic to cannabinoids or its other ingredients; anyone with a known or suspected personal or family history of schizophrenia or other psychotic illness; anyone with a history of severe personality disorder or another significant psychiatric disorder other than depression related to their MS; and during breastfeeding, because animal studies found cannabinoids concentrated in breast milk at 40 to 60 times blood levels. It should not be used in pregnancy unless the benefit outweighs the risk to the baby. Men and women who could conceive should use reliable contraception during treatment and for three months after, and because Sativex may make hormonal contraceptives less effective, people relying on them should add a barrier method. Sativex is not recommended in serious cardiovascular disease, needs caution with a history of epilepsy or seizures, and may be more prone to misuse in people with a history of substance misuse. It is not recommended for anyone under 18.

Interactions: THC and CBD are broken down by liver enzymes. The strong CYP3A4 inhibitor ketoconazole raised THC exposure 1.8-fold, its main metabolite 3.6-fold, and CBD twofold, so starting or stopping drugs such as itraconazole, ritonavir, or clarithromycin may require retitration. Fluconazole, which inhibits CYP2C9, raised THC exposure by about a third and its metabolite 11-hydroxy-THC about 2.5-fold. Strong enzyme inducers work the other way: rifampicin cut levels of THC, its metabolite, and CBD, so the product information advises avoiding rifampicin, carbamazepine, phenytoin, phenobarbital, and St John’s wort where possible. Sativex may induce the enzymes CYP1A2 and CYP2B6, can inhibit the enzymes UGT1A9 and UGT2B7, relevant to drugs such as propofol, and needs caution in people with Gilbert’s syndrome. Sleeping pills, sedatives, other sedating drugs, muscle relaxants such as baclofen and benzodiazepines, and alcohol may add to sedation and weakness and raise the risk of falls, and alcohol should be avoided, especially when starting or changing the dose.

Stop Sativex immediately and get medical advice for disorientation, confusion, hallucinations, delusions, a psychotic reaction, or thoughts of suicide; the product information says the person should be monitored until symptoms have fully resolved. Falls are a specific risk when spasticity eases in someone whose leg muscles are too weak to hold posture. Patients should not drive, operate machinery, or do anything hazardous while dizzy or sleepy, and a few cases of loss of consciousness have occurred. In the UK, it is an offense to drive while impaired by this medicine, though patients have a legal defense if it was prescribed, taken as directed, and not affecting their driving. Dependence appears unlikely: stopping long-term treatment caused at most brief disturbances of sleep, mood, or appetite, and doses did not creep up over time. Abuse potential is real at high doses, however: four sprays at once did not differ from placebo, but 8 to 16 sprays at once were comparable to equivalent doses of dronabinol.

06 Questions

Frequently Asked Questions

Two soft extracts of cannabis leaf and flower, made with liquid carbon dioxide, that together give 27 mg of THC and 25 mg of CBD per milliliter. Each 100-microliter spray therefore delivers 2.7 mg of THC and 2.5 mg of CBD, along with up to 40 mg of alcohol, propylene glycol, and peppermint oil for flavor. The spray is absorbed through the lining of the mouth. Its generic name is nabiximols.

For some people. Two early phase 3 trials found a small or no average benefit, but in a trial that first gave Sativex to 572 people for four weeks, the 241 eligible responders who continued kept their improvement, while those switched to placebo got worse. By week 16, 74% on Sativex and 51% on placebo had a 30% improvement. That is why treatment starts with a four-week trial and continues only if spasticity falls by at least 20%.

The evidence says no for the pain conditions tested. Two phase 3 trials in advanced cancer pain not controlled by opioids missed their main goals, and a 2026 Cochrane review found that balanced THC and CBD products gave a benefit in nerve pain too small to be clinically relevant. NICE advises against offering THC with CBD for chronic pain. Sativex is licensed only for MS spasticity.

At licensed doses it usually causes little intoxication, because blood THC rises slowly and peaks far lower than after smoking or vaping. Euphoric mood, a feeling of being drunk, dizziness, and confusion are still listed side effects, especially while the dose is being found. Taking 8 to 16 sprays at once showed abuse potential similar to dronabinol, and very high doses caused short-lived psychosis in a few volunteers. Never exceed 12 sprays a day.

Not until you know how it affects you, and never while dizzy or drowsy. Sativex can impair thinking and has caused a few cases of loss of consciousness. In the UK it is an offense to drive while impaired by this medicine, but you have a legal defense if it was prescribed, you took it as directed, and it was not affecting your driving. Alcohol adds to its effects and should be avoided, especially when starting or changing the dose.

Antifungals such as ketoconazole and fluconazole, and drugs such as clarithromycin and ritonavir, can raise its levels. Rifampicin, carbamazepine, phenytoin, phenobarbital, and St John’s wort can lower them and should be avoided where possible. Sleeping pills, sedatives, baclofen, benzodiazepines, and alcohol add to drowsiness and the risk of falls, and Sativex may make hormonal contraceptives less effective. Tell your specialist and pharmacist whenever you start or stop a medicine, because the dose may need adjusting.

No. FDA has approved Epidiolex, a purified CBD medicine, and the THC-type drugs dronabinol (Marinol and Syndros) and nabilone (Cesamet), but not Sativex or cannabis itself. Sativex is licensed in the UK, where it was first authorized in 2010, and NCCIH reports that it has been approved in more than 25 countries. Its legal status varies, and its product information advises checking the rules before traveling with it.

No. Sativex is a standardized, prescription medicine with a known dose in every spray, tested in controlled trials and started under a specialist with a four-week review. Dispensary cannabis oils vary widely in THC and CBD, and shop CBD oils contain little or no THC; NCCIH warns that cannabis products may be mislabeled or contaminated. The trial results for Sativex do not transfer to these products, even those with a similar THC to CBD ratio. For how THC and CBD differ, see the cannabis monograph.

07 References

Sources

These references support the claims on this page. They are not an endorsement of any product. Each ingredient’s monograph carries its own full source list.

  1. Sativex Oromucosal Spray: Summary of Product Characteristics

    SVX Therapeutics Ltd, via the Electronic Medicines Compendium, 2026

    Revised April 2026; first authorized 16 June 2010: composition, MS spasticity indication, titration to 12 sprays, four-week review, contraindications, warnings, ketoconazole, fluconazole, and rifampicin data, side effects, phase 3 and withdrawal trials, pediatric trial, pharmacokinetics.

  2. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis

    European Journal of Neurology (PubMed 21362108), 2011

    Novotna et al.: 572 patients in a four-week single-blind phase; 241 responders randomized for 12 weeks; spasticity difference 0.84 points favoring Sativex; spasm frequency and sleep disruption improved.

  3. Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies

    British Journal of Pain (PubMed 28785408), 2017

    Fallon et al.: two phase 3 trials in opioid-resistant cancer pain did not meet their primary endpoints.

  4. Cannabis-based medicines for chronic neuropathic pain in adults

    Cochrane Database of Systematic Reviews (PubMed 41548880), 2026

    Ateş et al.: 21 studies, 2,187 participants; balanced THC and CBD products added 7% moderate pain relief, judged not clinically relevant; more withdrawals for adverse events.

  5. Cannabis-based medicinal products (NG144): Recommendations

    National Institute for Health and Care Excellence (NICE), 2019

    Offer a four-week trial of THC:CBD spray for moderate to severe MS spasticity, continuing if spasticity falls by at least 20%; do not offer THC with CBD for chronic pain; not in breastfeeding.

  6. Cannabis (Marijuana) and Cannabinoids: What You Need To Know

    National Center for Complementary and Integrative Health (NIH), 2019

    Nabiximols approved in more than 25 countries but not the US; 2010 analysis of 666 people with MS; 2014 American Academy of Neurology guideline; cannabis products may be contaminated or mislabeled.

  7. FDA and Cannabis: Research and Drug Approval Process

    U.S. Food and Drug Administration, 2023

    FDA has approved Epidiolex, Marinol, Syndros, and Cesamet, but not cannabis itself.

  8. Does cannabidiol make cannabis safer? A randomised, double-blind, cross-over trial of cannabis with four different CBD:THC ratios

    Neuropsychopharmacology (PubMed 36380220), 2023

    Englund et al.: in 46 healthy volunteers, CBD at 1:1 to 3:1 ratios did not reduce the acute cognitive or psychotic effects of 10 mg inhaled THC.

  9. The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin

    British Journal of Pharmacology (PubMed 17828291), 2008

    Pertwee: THC is a partial agonist at CB1 and CB2 receptors; CBD can antagonize cannabinoid receptor agonists.

  10. Pharmacokinetics and pharmacodynamics of cannabinoids

    Clinical Pharmacokinetics (PubMed 12648025), 2003

    Grotenhermen: THC effects by route; acute overdose effects include anxiety, panic, and heart rate changes; mild withdrawal with regular use.

  11. Health Effects of Marijuana and Cannabis-Derived Products Presented in New Report

    National Academies of Sciences, Engineering, and Medicine, 2017

    Substantial evidence that oral cannabinoids improve patient-reported MS spasticity; cannabis use likely increases the risk of psychosis and impairs driving.