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Tetrahydrocannabinol/cannabinol/cannabidiol

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(Redirected fromZenivol)

Pharmaceutical compound
THC/CBN/CBD
Tetrahydrocannabinol (THC) (top) and
cannabidiol (CBD) (bottom)
Combination of
TetrahydrocannabinolCannabinoid
CannabinolCannabinoid
CannabidiolCannabinoid
Clinical data
Trade namesZenivol
Other namesTHC/CBN/CBD; ZTL-101; ZTL101
Routes of
administration
Sublingual
Drug classCannabinoids;Cannabinoid receptormodulators

Tetrahydrocannabinol/cannabinol/cannabidiol (THC/CBN/CBD), sold under the brand nameZenivol and also known by its developmental code nameZTL-101, is acannabinoidmedication used for the treatment ofinsomnia. It is approved and marketed inGermany.[1]

Medical uses

[edit]

THC/CBN/CBD is indicated for the management ofinsomnia. Clinical trials have shown that it improvestime to sleep, reducesnighttime awakenings, increasestotal sleep time, and enhancessleep quality andfeeling refreshed after sleep.[2][3][4]

Available forms

[edit]

The drug is administeredsublingually as aliquid using asyringe about 1 hour before bedtime.[1][3][4] Each 0.5 mL dose contains 10 mgδ9-tetrahydrocannabinol (THC), 1 mgcannabinol (CBN), and 0.5 mgcannabidiol (CBD), corresponding to a 20:2:1 mg/mL ratio.[2][3][4]One or two doses are typically taken per night.[4]

Adverse effects

[edit]

Reportedside effects are generally mild and resolve upon waking.[2][3][4]They includedry mouth,dizziness,headache, and "feeling abnormal".[2][3][4]

Pharmacology

[edit]

Pharmacokinetics

[edit]

Thepharmacokinetics of the formulation have been investigated and described in clinical studies.[4]

Pharmacodynamics

[edit]

THC is a psychoactivecannabinoid acting as aCB1 andCB2 receptorpartial agonist.CBN is a mildly psychoactive cannabinoid that also acts as a CB1 and CB2 receptor partial agonist.CBD does not act as an agonist at cannabinoid receptors but modulates theendocannabinoid system and othermolecular targets.[2][4][5][6]THC/CBN/CBD does not significantly altersleep architecture, aside from a near-significant 3.5% reduction inREM sleep duration.[2][4]

History

[edit]

THC/CBN/CBD was approved and launched as apharmaceutical drug for insomnia inGermany in 2022.[1]It was developed and is marketed by Zelira Therapeutics.[1]

See also

[edit]

References

[edit]
  1. ^abcd"Cannabidiol/tetrahydrocannabinol".AdisInsight. 25 July 2022. Retrieved1 October 2025.
  2. ^abcdefMaddison KJ, Kosky C, Walsh JH (2022)."Is There a Place for Medicinal Cannabis in Treating Patients with Sleep Disorders? What We Know so Far".Nature and Science of Sleep.14:957–968.doi:10.2147/NSS.S340949.PMC 9124464.PMID 35611178.
  3. ^abcdeLavender I, McGregor IS, Suraev A, Grunstein RR, Hoyos CM (August 2022). "Cannabinoids, Insomnia, and Other Sleep Disorders".Chest.162 (2):452–465.doi:10.1016/j.chest.2022.04.151.PMID 35537535.The most robustly designed study to date examined the safety and efficacy of the cannabinoid formulation ZTL101 (D9-THC 10 mg, CBN 1 mg, and CBD 0.5 mg) relative to placebo in a sample of 23 patients with chronic insomnia disorder.11 Participants self-administered ZTL-101 one hour prior to bedtime for 2 weeks, with the option to double the dose after the fourth night (52% of participants increased the dose). ZTL-101 improved subjective sleep quality by 5.1 points (95% CI, –7.3 to –2.9) on the Insomnia Severity Index and improved self-reported sleep-onset latency, total sleep time, subjective sleep quality, and feelings of rest upon waking. Actigraphy measures indicated reduced wake following sleep onset and increased total sleep time; however, no differences in polysomnography indexes were observed.11 Headaches, xerostomia, dizziness, and "feeling abnormal" were reported more frequently with active treatment (n = 17) than with placebo (n = 4), but these adverse events were self-limiting and did not persist upon wake.
  4. ^abcdefghiWalsh JH, Maddison KJ, Rankin T, Murray K, McArdle N, Ree MJ, et al. (November 2021)."Treating insomnia symptoms with medicinal cannabis: a randomized, crossover trial of the efficacy of a cannabinoid medicine compared with placebo".Sleep.44 (11) zsab149.doi:10.1093/sleep/zsab149.PMC 8598183.PMID 34115851.
  5. ^Sampson PB (January 2021). "Phytocannabinoid Pharmacology: Medicinal Properties ofCannabis sativa Constituents Aside from the "Big Two"".Journal of Natural Products.84 (1):142–160.doi:10.1021/acs.jnatprod.0c00965.PMID 33356248.
  6. ^Britch SC, Babalonis S, Walsh SL (January 2021)."Cannabidiol: pharmacology and therapeutic targets".Psychopharmacology.238 (1):9–28.doi:10.1007/s00213-020-05712-8.PMC 7796924.PMID 33221931.
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