Epidyolex 100 mg/ml oral solution: Summary of Product Characteristics
- Population
- Patients with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex
- Product
- Epidyolex (a different cannabidiol medicine)
- Design
- Regulatory product information
- Finding
- The UK product information lists Epidyolex as an add-on treatment for seizures associated with Lennox–Gastaut or Dravet syndrome, together with clobazam, and for seizures associated with tuberous sclerosis complex, in patients aged 2 years and older. Its side effects include sleepiness and raised liver enzymes (especially with valproate); interacts with clobazam.
- Limitations
- Epilepsy populations at higher doses per kg; not evidence about psychosis.
Source: Epidyolex 100 mg/ml oral solution: Summary of Product Characteristics. Electronic Medicines Compendium. Date of revision of the text 8 June 2026. Official source
Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome
- Population
- 120 children and young adults with Dravet syndrome
- Product
- Purified oral CBD solution (not NWPT-SM32300)
- Design
- Randomised, double-blind, placebo-controlled trial
- Finding
- CBD 20 mg/kg/day reduced convulsive seizures versus placebo. Common side effects included diarrhoea, vomiting, fatigue, fever, sleepiness and abnormal liver tests.
- Limitations
- Epilepsy, not psychosis; cited here for safety information.
Source: Devinsky O, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med. 2017;376(21):2011-2020. DOI 10.1056/NEJMoa1611618 · PubMed 28538134
The contribution of cannabis use to variation in the incidence of psychotic disorder across Europe (EU-GEI): a multicentre case-control study
- Population
- 901 people with first-episode psychosis and 1,237 controls, 11 sites
- Product
- Street cannabis (THC), not CBD
- Design
- Case-control study
- Finding
- Daily cannabis use, and especially daily use of high-potency (high-THC) cannabis, was associated with higher odds of psychotic disorder.
- Limitations
- Association, not proof of cause; about THC-rich cannabis, not CBD.
Source: Di Forti M, et al. The contribution of cannabis use to variation in the incidence of psychotic disorder across Europe (EU-GEI): a multicentre case-control study. Lancet Psychiatry. 2019;6(5):427-436. DOI 10.1016/S2215-0366(19)30048-3 · PubMed 30902669
CBD research
Emerging evidence
Opposite effects of Δ-9-tetrahydrocannabinol and cannabidiol on human brain function and psychopathology
- Population
- 15 healthy men (plus 6 in a pretreatment experiment)
- Product
- Oral THC and CBD (not NWPT-SM32300)
- Design
- Experimental brain-imaging study
- Finding
- THC and CBD had opposite effects on activity in several brain regions; CBD pretreatment prevented THC-induced psychotic symptoms in a small group.
- Limitations
- Very small, healthy volunteers, single doses; mechanism, not clinical benefit.
Source: Bhattacharyya S, Morrison PD, Fusar-Poli P, et al. Opposite effects of Δ-9-tetrahydrocannabinol and cannabidiol on human brain function and psychopathology. Neuropsychopharmacology. 2010;35(3):764-774. DOI 10.1038/npp.2009.184 · PubMed 19924114
CBD research
Emerging evidence
Cannabidiol (CBD) as an adjunctive therapy in schizophrenia: a multicenter randomized controlled trial
- Population
- 88 adults with schizophrenia already taking antipsychotics
- Product
- Oral CBD solution, 1,000 mg/day (not NWPT-SM32300)
- Design
- Randomised, double-blind, placebo-controlled; 6 weeks
- Finding
- Positive psychotic symptoms fell more with CBD than placebo (small difference), and clinicians more often rated patients as improved. Generally well tolerated.
- Limitations
- Small, short, add-on treatment in established schizophrenia; not people at clinical high risk.
Source: McGuire P, Robson P, Cubala WJ, et al. Cannabidiol (CBD) as an adjunctive therapy in schizophrenia: a multicenter randomized controlled trial. Am J Psychiatry. 2018;175(3):225-231. DOI 10.1176/appi.ajp.2017.17030325 · PubMed 29241357
CBD research
Emerging evidence
Cannabidiol enhances anandamide signaling and alleviates psychotic symptoms of schizophrenia
- Population
- 42 inpatients with acute schizophrenia
- Product
- Oral CBD up to 800 mg/day (not NWPT-SM32300)
- Design
- Randomised, double-blind, active comparator (amisulpride); 4 weeks
- Finding
- Symptoms improved similarly with CBD and amisulpride; CBD had fewer movement side effects, less weight gain and a smaller prolactin rise.
- Limitations
- Small and short; no placebo group, so the size of any CBD effect alone is uncertain.
Source: Leweke FM, et al. Cannabidiol enhances anandamide signaling and alleviates psychotic symptoms of schizophrenia. Transl Psychiatry. 2012;2(3):e94. DOI 10.1038/tp.2012.15 · PubMed 22832859
CBD research
Emerging evidenceNegative finding
The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia: a randomized placebo controlled trial
- Population
- 36 outpatients with chronic schizophrenia
- Product
- Oral CBD 600 mg/day (not NWPT-SM32300)
- Design
- Randomised, double-blind, placebo-controlled; 6 weeks
- Finding
- No improvement in cognition or symptoms compared with placebo.
- Limitations
- Small; lower dose than some other studies; stable chronic patients.
Source: Boggs DL, Surti T, et al. The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia: a randomized placebo controlled trial. Psychopharmacology (Berl). 2018;235(7):1923-1932. DOI 10.1007/s00213-018-4885-9 · PubMed 29619533
CBD research
Emerging evidence
Effect of cannabidiol on medial temporal, midbrain, and striatal dysfunction in people at clinical high risk of psychosis: a randomized clinical trial
- Population
- 33 people at clinical high risk (16 CBD, 17 placebo) and 19 healthy volunteers
- Product
- Single oral CBD 600 mg dose (not NWPT-SM32300)
- Design
- Randomised, double-blind, placebo-controlled brain-imaging study
- Finding
- During a memory task, brain activity with CBD was intermediate between the placebo group and healthy volunteers in several regions.
- Limitations
- Single dose; brain-activity measures, not symptoms or outcomes.
Source: Bhattacharyya S, et al. Effect of cannabidiol on medial temporal, midbrain, and striatal dysfunction in people at clinical high risk of psychosis: a randomized clinical trial. JAMA Psychiatry. 2018;75(11):1107-1117. DOI 10.1001/jamapsychiatry.2018.2309 · PubMed 30167644
CBD research
Emerging evidenceMixed findings
Effects of short-term cannabidiol treatment on response to social stress in subjects at clinical high risk of developing psychosis
- Population
- 32 people at clinical high risk and 26 healthy volunteers
- Product
- Oral CBD 600 mg/day for 7 days (not NWPT-SM32300)
- Design
- Randomised, double-blind, placebo-controlled experimental study
- Finding
- Anxiety and stress responses to a public-speaking test were intermediate between placebo and healthy volunteers. The cortisol response did not differ significantly from placebo.
- Limitations
- One week; laboratory stress test, not clinical outcomes.
Source: Appiah-Kusi E, et al. Effects of short-term cannabidiol treatment on response to social stress in subjects at clinical high risk of developing psychosis. Psychopharmacology (Berl). 2020;237(4):1121-1130. DOI 10.1007/s00213-019-05442-6 · PubMed 31915861
CBD research
Emerging evidence
Effects of cannabidiol on symptoms in people at clinical high risk for psychosis
- Population
- 33 people at clinical high risk (16 CBD, 17 placebo)
- Product
- Oral CBD 600 mg/day for 21 days (not NWPT-SM32300)
- Design
- Randomised, placebo-controlled; published as a short research letter
- Finding
- After adjusting for starting scores, symptom and distress scores were lower with CBD than placebo; CBD was well tolerated.
- Limitations
- Very small, three weeks, short-letter format; not yet confirmed in a larger trial.
Source: Bhattacharyya S, Appiah-Kusi E, Wilson R, et al. Effects of cannabidiol on symptoms in people at clinical high risk for psychosis. World Psychiatry. 2024;23(3):451-452. DOI 10.1002/wps.21253 · PubMed 39279373
Critical aspects affecting cannabidiol oral bioavailability and metabolic elimination, and related clinical implications
- Population
- Review of human pharmacokinetic studies
- Product
- Cannabidiol in general (not NWPT-SM32300)
- Design
- Review
- Finding
- Taken by mouth while fasting, only about 6% of a CBD dose is estimated to reach the bloodstream; a high-fat meal increases this about fourfold. Much of each dose is broken down by the liver before reaching the circulation.
- Limitations
- Review of other CBD preparations; figures vary between studies.
Source: Perucca E, Bialer M. Critical aspects affecting cannabidiol oral bioavailability and metabolic elimination, and related clinical implications. CNS Drugs. 2020;34(8):795-800. DOI 10.1007/s40263-020-00741-5 · PubMed 32504461
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects
- Population
- Healthy adult volunteers
- Product
- Purified CBD oral solution (not NWPT-SM32300)
- Design
- Phase 1 randomised, placebo-controlled trial
- Finding
- Described the safety and tolerability of single and repeated doses of purified CBD in healthy adults, and found that a high-fat meal increased CBD exposure.
- Limitations
- Healthy volunteers; a different CBD product. A published correction exists.
Source: Taylor L, et al. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects. CNS Drugs. 2018;32(11):1053-1067. DOI 10.1007/s40263-018-0578-5 · PubMed 30374683