Dronabinol – trade names Marinol and Syndros – is a synthetic form
of tetrahydrocannabinol (THC) approved by the FDA as an appetite
stimulant for people with
AIDS and antiemetic for people receiving
chemotherapy. THC is the principal psychoactive constituent of
cannabis. With chemical name, (−)-trans-Δ⁹-tetrahydrocannabinol,
the term THC also refers to cannabinoid isomers. The pharmaceutical
formulation dronabinol is an oily resin provided in capsules available
by prescription in the US, Canada, Germany, and New Zealand.
1 Medical uses
2 Adverse effects
4 Society and culture
4.1 Brand names
4.1.1 Comparisons with medical cannabis
6 External links
Dronabinol is the INN for a pure isomer of THC,
(−)-trans-Δ⁹-tetrahydrocannabinol, which is the main THC
isomer found in cannabis. It is used to treat anorexia in people with
AIDS as well as for refractory nausea and vomiting in people
undergoing chemotherapy. It is safe and effective for these
A mild overdose of dronabinol induces drowsiness, euphoria, dry mouth,
and tachycardia, whereas a severe overdose presents with lethargy,
decreased motor coordination, slurred speech, and postural
A 2014 review of synthetic cannabinoids reported that acute
intoxication with dronabinol led in some cases to emergency
hospitalization, requiring supportive care, benzodiazepines, and fluid
replacement, whereas more severe cases involved cardiotoxicity or
psychosis, requiring hospitalization for as long as 2 weeks. Upon
cessation of abuse, some chronic users experienced withdrawal
symptoms, while deaths were rare.
On May 13, 1986, the
Drug Enforcement Administration
Drug Enforcement Administration (DEA) issued a
Final Rule and Statement of Policy authorizing the "rescheduling of
synthetic dronabinol in sesame oil and encapsulated in soft gelatin
capsules from Schedule I to Schedule II" (DEA 51 FR 17476-78). This
permitted medical use of Marinol, albeit with the severe restrictions
associated with Schedule II status. For instance, refills of
Marinol prescriptions were not permitted. At its 10th meeting, on
April 29, 1991, the Commission on
Narcotic Drugs, in accordance with
article 2, paragraphs 5 and 6, of the Convention on Psychotropic
Substances, decided that Δ⁹-tetrahydrocannabinol (also referred to
as Δ⁹-THC) and its stereochemical variants should be transferred
from Schedule I to Schedule II of that Convention. This released
Marinol from the restrictions imposed by Article 7 of the Convention
(See also United Nations Convention Against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances).
An article published in the April–June 1998 issue of the Journal of
Psychoactive Drugs found that "Healthcare professionals have detected
no indication of scrip-chasing or doctor-shopping among the patients
for whom they have prescribed dronabinol". The authors state that
Marinol has a low potential for abuse.
In 1999, Marinol was rescheduled from Schedule II to III of the
Controlled Substances Act, reflecting a finding that THC had a
potential for abuse less than that of cocaine and heroin. This
rescheduling constituted part of the argument for a 2002 petition for
removal of cannabis from Schedule I of the Controlled Substances Act,
in which petitioner
Jon Gettman noted, "
Cannabis is a natural source
of dronabinol (THC), the ingredient of Marinol, a Schedule III drug.
There are no grounds to schedule cannabis in a more restrictive
schedule than Marinol".
At its 33rd meeting, in 2003, the
World Health Organization
World Health Organization Expert
Committee on Drug Dependence recommended transferring THC to Schedule
IV of the Convention, citing its medical uses and low abuse
Society and culture
Dronabinol is marketed as Marinol and Syndros, a registered
trademark of Solvay Pharmaceuticals.
Dronabinol is also marketed,
sold, and distributed by PAR Pharmaceutical Companies under the terms
of a license and distribution agreement with SVC pharma LP, an
affiliate of Rhodes Technologies for Marinol and Insys Pharmaceuticals
for Syndros.
Dronabinol is available as a
prescription drug (under Marinol and Syndros ) in several
countries including the United States, Germany,
South Africa and
Australia. In the United States, Marinol is a Schedule III drug,
available by prescription, considered to be non-narcotic and to have a
low risk of physical or mental dependence. Efforts to get cannabis
rescheduled as analogous to Marinol have not succeeded thus far,
though a 2002 petition has been accepted by the DEA. As a result of
the rescheduling of Marinol from Schedule II to Schedule III, refills
are now permitted for this substance. Marinol's U.S. Food and Drug
Administration (FDA) approvals for medical use has raised much
controversy as to why natural THC is considered a schedule I
Comparisons with medical cannabis
Further information: Medical cannabis
Female cannabis plants contain at least 113 cannabinoids,
including cannabidiol (CBD), thought to be the major anticonvulsant
that helps people with multiple sclerosis; and cannabichromene
(CBC), an anti-inflammatory which may contribute to the pain-killing
effect of cannabis.
It takes over one hour for Marinol to reach full systemic effect,
compared to seconds or minutes for smoked or vaporized cannabis.
Some people accustomed to inhaling just enough cannabis smoke to
manage symptoms have complained of too-intense intoxication from
Marinol's predetermined dosages. Many people using
Marinol have said that Marinol produces a more acute psychedelic
effect than cannabis, and it has been speculated that this disparity
can be explained by the moderating effect of the many non-THC
cannabinoids present in cannabis. For that reason,
alternative THC-containing medications based on botanical extracts of
the cannabis plant such as nabiximols are being developed. Mark
Kleiman, director of the Drug Policy Analysis Program at UCLA's School
of Public Affairs said of Marinol, "It wasn't any fun and made the
user feel bad, so it could be approved without any fear that it would
penetrate the recreational market, and then used as a club with which
to beat back the advocates of whole cannabis as a medicine." Mr.
Kleiman's opinion notwithstanding, clinical trials comparing the use
of cannabis extracts with Marinol in the treatment of cancer cachexia
have demonstrated equal efficacy and well-being among subjects in the
two treatment arms.
United States federal law currently registers
dronabinol as a Schedule III controlled substance, but all other
cannabinoids remain Schedule I, except synthetics like nabilone.
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