Executive Office of the President
`Office of National Drug Control Policy
`
`ONDCP
`ONDCP
`
`November 2002
`November 2002
`
`Drug Policy Information Clearinghouse
`Drug Policy Information Clearinghouse
`FACT SHEET
`FACT SHEET
`
`John P. Walters, Director
`
`www.whitehousedrugpolicy.gov
`
`
`
`
`
` 1-800-666-3332
`
`Gamma Hydroxybutyrate (GHB)
`
`Background
`Gamma hydroxybutyrate (GHB) is a powerful, rapidly
`acting central nervous system depressant. It was first
`synthesized in the 1920s and was under development as
`an anesthetic agent in the 1960s. GHB is produced nat-
`urally by the body in small amounts but its physiologi-
`cal function is unclear.
`
`GHB was sold in health food stores as a performance-
`enhancing additive in bodybuilding formulas until the
`Food and Drug Administration (FDA) banned it in
`1990. It is currently marketed in some European coun-
`tries as an adjunct to anesthesia. GHB is abused for its
`ability to produce euphoric and hallucinogenic states
`and for its alleged function as a growth hormone that
`releases agents to stimulate muscle growth. GHB
`became a Schedule I Controlled Substance in March
`2000.
`
`In the United States, GHB is produced in clandestine
`laboratories with no guarantee of quality or purity,
`making its effects less predictable and more difficult
`to diagnose. GHB can be manufactured with inex-
`pensive ingredients and using recipes on the Internet.
`Gamma butyrolactone (GBL) and 1,4-butanediol are
`analogs of GHB that can be substituted for it. Once
`ingested, these analogs convert to GHB and produce
`identical effects. GBL, an industrial solvent, is used as
`an immediate precursor in the clandestine production of
`GHB. The FDA has issued warnings for both GBL and
`1,4-butanediol, stating that the drugs have a potential for
`abuse and are a public health danger.
`
`Effects
`GHB is usually taken orally. It is sold as a light-colored
`powder that easily dissolves in liquids or as a pure
`
`liquid packaged in vials or small bottles. In liquid form,
`it is clear, odorless, tasteless, and almost undetectable
`when mixed in a drink. GHB is typically consumed by
`the capful or teaspoonful at a cost of $5 to $10 per dose.
`The average dose is 1 to 5 grams and takes effect in 15
`to 30 minutes, depending on the dosage and purity of
`the drug. Its effects last from 3 to 6 hours.
`
`Consumption of less than 1 gram of GHB acts as a
`relaxant, causing a loss of muscle tone and reduced
`inhibitions. Consumption of 1 to 2 grams causes a
`strong feeling of relaxation and slows the heart rate
`and respiration. At this dosage level, GHB also inter-
`feres with blood circulation, motor coordination, and
`balance. In stronger doses, 2 to 4 grams, pronounced
`interference with motor and speech control occurs. A
`coma-like sleep may be induced, requiring intubation
`to wake the user. When mixed with alcohol, the
`depressant effects of GHB are enhanced. This can
`lead to respiratory depression, unconsciousness,
`coma, and overdose.
`
`Side effects associated with GHB may include nausea,
`vomiting, delusions, depression, vertigo, hallucinations,
`seizures, respiratory distress, loss of consciousness,
`slowed heart rate, lowered blood pressure, amnesia, and
`coma. GHB can become addictive with sustained use.
`
`Patients with a history of around-the-clock use of GHB
`(every 2 to 4 hours) exhibit withdrawal symptoms
`including anxiety, insomnia, tremors, and episodes of
`tachycardia (abnormally fast heart rates), and may
`progress to delirium and agitation. Because GHB has a
`short duration of action and quickly leaves the user’s
`system, withdrawal symptoms may occur within 1 to 6
`hours of the last dose. These symptoms may last for
`many months.
`
`NCJ 194881
`
`JAZZ EXHIBIT 2005
`Par Pharm., Inc. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case CBM2014-00151
`
`Page 1 of 4
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`

`

`According to the Drug Abuse Warning Network
`(DAWN), GHB emergency department (ED) mentions
`have increased from 56 in 1994 to 3,340 in 2001 (see
`table).
`
`Estimated number of emergency department GHB
`mentions, 1994–2001
`
`1994
`56
`
`1995
`145
`
`1996
`638
`
`1997
`762
`
`1998
`1,282
`
`1999
`3,178
`
`2001
`2000
`4,969 3,340
`
`Source: Drug Abuse Warning Network.
`
`GHB-related deaths have occurred in several Com-
`munity Epidemiology Work Group (CEWG) sites. In
`1999, there were three reported deaths involving GHB
`in Texas and two in Minnesota. Missouri has reported
`five GHB-related deaths and two near deaths in which
`GHB was used to facilitate rapes. In Florida, during
`2000, GHB was detected in 23 deaths and identified
`as the cause of death in 6 cases. Since 1990, the U.S.
`Drug Enforcement Administration (DEA) has docu-
`mented more than 15,600 overdoses and law enforce-
`ment encounters and 72 deaths relating to GHB.
`
`Prevalence Estimates
`GHB is often ingested with alcohol by young adults and
`teens at nightclubs and parties. It is used as a pleasure
`enhancer that depresses the central nervous system and
`induces intoxication. It also can be used as a sedative to
`reduce the effects of stimulants (cocaine, methampheta-
`mine, ephedrine) or hallucinogens (LSD, mescaline)
`and to prevent physical withdrawal symptoms.
`
`Since 2000, GHB has been included in the University
`of Michigan’s Monitoring the Future Survey question-
`naire. Survey results indicate that annual GHB use by
`secondary school students in 2000 ranged from 1.1%
`among 10th graders to 1.2% among 8th graders and
`1.9% among 12th graders. In 2001, estimates of annual
`GHB use ranged from 1.0% among 10th graders to
`1.1% among 8th graders and 1.6% among 12th graders.
`
`Regional Observations
`According to CEWG, as of 2001, 15 CEWG areas
`reported increases in GHB indicators. They were
`Boston, Chicago, Dallas/Houston, Denver, Los
`Angeles, Miami, Minneapolis/St. Paul, Newark, New
`York, Philadelphia, Phoenix, St. Louis, San Diego, San
`Francisco, and Seattle. Atlanta, Baltimore, and
`Washington, D.C., reported stable GHB indicators.
`Only two CEWG sites, Detroit and New Orleans,
`reported declines in GHB indicators. Most CEWG
`areas report that GHB is frequently used in combina-
`tion with alcohol, causing users to overdose.
`
`In 2000, according to the National Drug Intelligence
`Center (NDIC), GHB availability was stable or increas-
`ing in nearly every DEA Field Division and High In-
`tensity Drug Trafficking Area. Many areas reported that
`the increased availability of GHB occurred in concert
`with a rise in rave activity. Law enforcement also
`reported increases in the number of cases involving
`GHB analogs.
`
`According to Pulse Check: Trends in Drug Abuse, GHB
`users and sellers tend to be between the ages of 18 and
`30. Most users are middle-class white males. GHB is
`typically packaged in plastic bottles (mostly water or
`sports drink bottles) and distributed by the capful for
`$5–$20 per dose. Additional packaging includes eye-
`dropper bottles, glass vials, and mouthwash bottles.
`
`Drug-Facilitated Rape
`Drug-facilitated rape is defined as sexual assault made
`easier by the offender’s use of an anesthetic-type drug
`that renders the victim physically incapacitated or help-
`less and unable to consent to sexual activity. Whether
`the victim is unwittingly administered the drug or
`willingly ingests it for recreational use is irrelevant—
`the person is victimized because of their inability to
`consciously consent to sexual acts.
`
`According to NDIC, GHB has surpassed Rohypnol
`(flunitrazepam) as the most common substance used in
`drug-facilitated sexual assaults. GHB can mentally and
`physically paralyze an individual, and these effects are
`intensified when the drug is combined with alcohol. To
`date, DEA has documented 15 sexual assaults involving
`30 victims who were under the influence of GHB. Of
`the 711 drug-positive urinalysis samples submitted from
`victims of alleged sexual assault, 48 tested positive for
`GHB.
`
`It is difficult to estimate the incidence of drug-facilitated
`rape involving GHB. Victims may not seek help until
`days after the assault, in part because the drug impairs
`their memory and in part because they may not identify
`signs of sexual assault. GHB is only detectable in a
`person’s system for a limited amount of time and, if the
`victim does not seek immediate help, the opportunity to
`detect the drug can quickly pass. Also, law enforce-
`ment agencies may not be trained to gather necessary
`evidence and may not be using equipment that is sensi-
`tive enough to test for the drug.
`
`Scheduling and Legislation
`In response to the use of drugs in sexual assaults, Con-
`gress passed the Drug-Induced Rape Prevention and
`Punishment Act of 1996 to combat drug-facilitated
`crimes of violence, including sexual assaults. The act
`
`2
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`

`imposes harsh penalties for distribution of a controlled
`substance to an individual without the individual’s
`knowledge and consent with intent to commit a crime
`of violence, including rape.
`
`On February 18, 2000, the Hillory J. Farias and
`Samantha Reid Date-Rape Prevention Act of 2000
`(Public Law 106-72) became law. It made GBL a List I
`chemical subject to the criminal, civil, and administra-
`tive sanctions of the Federal Controlled Substances
`Act of 1970. As a result of the law, GHB became a
`Schedule I Controlled Substance. A Schedule I drug has
`a high potential for abuse, is not currently accepted for
`medical use in treatment in the United States, and lacks
`accepted safety for use under medical supervision.
`
`On March 20, 2001, the Commission on Narcotic Drugs
`placed GHB in Schedule IV of the 1971 Convention
`of Psychotropic Substances. This placement affects
`international drug control laws with which countries
`that are a part of the convention must comply.
`Schedule IV mandates international requirements on
`licensing for manufacture, trade, and distribution of the
`drug. It also requires parties to comply with prohibition
`of and restrictions on export and import of the drug and
`to adopt measures for the repression of acts contrary to
`these laws and regulations.
`
`On July 17, 2002, Xyrem, a drug with an active ingredi-
`ent of sodium oxybate or GHB, was approved by the
`FDA to treat cataplexy attacks in patients with nar-
`colepsy. Cataplexy is a condition characterized by weak
`or paralyzed muscles. Xyrem, when used as medically
`prescribed, is a Schedule III Controlled Substance. A
`Schedule III Controlled Substance has less potential for
`abuse than Schedule I and II categories, is currently
`accepted for medical use in treatment in the United
`States, and may lead to moderate or low physical
`dependence. Illicit use of Xyrem is subject to Schedule
`I penalties.
`
`Street Terms
`
`Street terms for GHB
`
`Cherry Meth
`Fantasy
`GBH
`Georgia home boy
`Great hormones at bedtime
`Grievous bodily harm
`Liquid E
`Liquid Ecstasy
`
`Liquid X
`Organic quaalude
`Salty water
`Scoop
`Sleep-500
`Soap
`Somatomaz
`Vita-G
`
`Resources
`ClubDrugs.org. National Institute on Drug Abuse.
`www.clubdrugs.org
`
`Club Drugs. INFOFAX, National Institute on Drug Abuse.
`www.nida.nih.gov/Infofax/Clubdrugs.html
`
`GHB Analogs: GBL, BD, GHV, and GVL. National Drug
`Intelligence Center, August 2002.
`www.usdoj.gov/ndic/pubs/1621/1621p.pdf
`
`The Prosecution of Rohypnol and GHB Related Sexual
`Assaults. American Prosecutors Research Institute, 1999.
`www.ndaa.org/publications.apri/violence_against_
`women.html
`
`Rapists Are Using a New Weapon to Overpower Their
`Victims. Santa Monica Hospital Medical Center, Rape
`Treatment Center, 1997.
`www.911rape.org/request/blowouts/brochure.html
`
`Sources
`Executive Office of the President:
`
`Office of National Drug Control Policy
`
`Pulse Check: Trends in Drug Abuse, April 2002,
`NCJ 193398.
`www.whitehousedrugpolicy.gov/publications/drugfact/
`pulsechk/2001/index.html
`
`Street Terms: Drugs and the Drug Trade.
`www.whitehousedrugpolicy.gov/streetterms/default.asp
`
`U.S. Department of Health and Human Services:
`
`National Institute on Drug Abuse
`
`Epidemiologic Trends in Drug Abuse, Volume I: Highlights
`and Executive Summary, June 2001, Community
`Epidemiology Work Group.
`www.drugabuse.gov/PDF/CEWG/EXSUMJune01.pdf
`
`Epidemiologic Trends in Drug Abuse, Volume I: Highlights
`and Executive Summary, December 2001, Community
`Epidemiology Work Group.
`www.drugabuse.gov/PDF/CEWG/EXSUMDec01.pdf
`
`Monitoring the Future: National Results on Adolescent
`Drug Use, Overview of Key Findings, 2001, 2002.
`monitoringthefuture.org/pubs/monographs/
`overview2001.pdf
`
`Substance Abuse and Mental Health Services
`Administration
`
`“Detailed Emergency Department Tables From the Drug
`Abuse Warning Network, 2001,” Emergency Department
`
`3
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`

`Trends From the Drug Abuse Warning Network, Final
`Estimates 1994–2001.
`www.samhsa.gov/oas/DAWN/DetEDAnnual/2001/Text/
`DetEDtext.pdf
`
`U.S. Department of Justice:
`
`Drug Enforcement Administration
`
`Diversion Control Program, Drugs and Chemicals of
`Concern: Gamma Hydroxybutyric Acid.
`www.deadiversions.usdoj.gov/drugs-concern/ghb/
`summary.html
`
`Gamma Hydroxybutyric Acid (GHB, Liquid X, Goop,
`Georgia Home Boy), November 27, 2000.
`
`Gamma Hydroxybutyric Acid.
`www.usdoj.gov/dea/concern/ghb.html
`
`National Drug Intelligence Center
`
`National Drug Threat Assessment 2002, December 2001.
`www.usdoj.gov/ndic/pubs/716/index.htm
`
`National Institute of Justice
`
`“Drug-Facilitated Rape: Looking for the Missing Pieces,”
`NIJ Journal, April 2000.
`www.ncjrs.org/pdfflies1/jr000243c.pdf
`
`Office of Justice Programs, National Criminal Justice
`Reference Service
`
`In the Spotlight: Club Drugs.
`www.ncjrs.org/club_drugs/club_drugs.html
`
`U.S. Food and Drug Administration:
`
`FDA Talk Paper, “FDA Approves Xyrem for Cataplexy
`Attacks in Patients With Narcolepsy,” July 17, 2002.
`www.fda.gov/bbs/topics/ANSWERS/2002/ANS01157.html
`
`Other Source:
`
`Texas Department of Health, Texas Commission on
`Alcohol and Drug Abuse, GHB Withdrawal Syndrome,
`March 2001.
`www.tcada.state.tx.us/research/ghb_withdrawal.pdf
`
`This fact sheet was prepared by Jennifer Lloyd of the ONDCP Drug Policy Information Clearinghouse. The
`data presented are as accurate as the sources from which they were drawn. Responsibility for data selection and
`presentation rests with the Clearinghouse staff. The Clearinghouse is funded by the White House Office of
`National Drug Control Policy to support drug control policy research. The Clearinghouse is a component of the
`National Criminal Justice Reference Service. For further information about the contents or sources used for the
`production of this fact sheet or about other drug policy issues, call:
`1–800–666–3332
`
`Write the Drug Policy Information Clearinghouse, P.O. Box 6000, Rockville, MD 20849–6000,
`or visit the World Wide Web site at:
`
`www.whitehousedrugpolicy.gov
`
`*NCJ~194881*
`
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