Flunitrazepam - Regional Use

Regional Use

• In Australia, prescription is restricted as a Schedule 8 medicine. It is used primarily for the treatment of severe insomnia that has not responded to other treatments. In some states, it is also manufactured in generic form by Alphapharm under the name Hypnodorm. As a Schedule 8 medicine, it is illegal to have this drug in possession without an authority prescription from a registered doctor.
• In France, Rohypnol is prescribed by physicians, it is under the maximum list, being prescribed only when other drugs will not do, prescription nonrenewable (a new doctor visit every time), and being available only in 7-pill, in theory one-week, packaging.
• In Germany, flunitrazepam is available for prescription as the Roche-Brand Rohypnol 1 mg Film-Coated Tablets and several generic 1 mg tablets (e.g., Fluninoc, Flunitrazepam ratiopharm, Flunitrazepam neuraxpharm).
• In Ireland, flunitrazepam is a Schedule 3 controlled substance with strict restrictions.
• In Japan, flunitrazepam is marketed by Japanese pharmaceutical company Chugai under the tradename Rohypnol, by Japanese pharmaceutical company Eisai under the name of Silece and by some manufacturers as generic drugs. Flunitrazepam is indicated for the treatment of insomnia as well as used for preanesthetic medication.
• In Mexico, Rohypnol is approved for medical use.
• In the Netherlands, flunitrazepam is a List 2 substance of the Opium Law and is available for prescription as 1 mg Rohypnol brand tablets by Roche, and as 1 mg and 2 mg generic tablets.
• In Norway, flunitrazepam is available as a prescription drug to treat insomnia under the brand name Flunipam 1 mg. It is a Class A substance under Norway's Narcotics Act. Only four hypnotics are prescribable in Norway: flunitrazepam, nitrazepam, zolpidem and zopiclone.
• In Singapore, flunitrazepam is a Class C controlled drug (Schedule II), making it illegal to possess without a proper medical prescription.
• In Slovenia, it is regulated as a Group III (Schedule 3) controlled substance under The Production and Trade in Illicit DrugsAct. About 20 years ago, Rohypnol was indicated for treatment of insomnia as well as used for preanesthetic medication, replaced mainly with Dormicum (midazolam), which has very similar properties.
• In South Africa, Rohypnol is classified as a schedule 6 drug. It is available by prescription only, and restricted to 1 mg doses. Travelers from South Africa to the United States are limited to a 30-day supply. The drug must be declared to US Customs upon arrival. If a valid prescription cannot be produced, the drug may be subject to Customs search and seizure, and the traveler may face criminal charges or deportation.
• In Sweden, the brand Rohypnol has been withdrawn from the domestic market. It is available under the name Flunitrazepam Mylan. It is listed as a List IV (Schedule IV) under the Narcotics Control Act (1968). Although it has for a long time been a first-line drug for the treatment of insomnia, it has seen declines in prescriptions in recent years. Much more common are nitrazepam, but above all zopiclone and zolpidem.
• In the United Kingdom, the drug is available only by private prescription. Though Rohypnol was discontinued in 1986, Flunitrazepam use is still present in modern culture; among other uses, it is used in some hospitals to sedate patients undergoing colonoscopy.
• In the United States, the drug has not been approved by the Food and Drug Administration and is considered to be an illegal drug.

Flunitrazepam is marketed by Roche most commonly under the trade name Rohypnol. It is also marketed in some countries under the trade names Flunitrazepam, Hipnosedon, Hypnodorm, Flunipam, Nilium, Vulbegal, Silece, Darkene, Ilman, Insom, Inervon and Fluscand. In street slang, the pharmaceutical is commonly referred to as a roofie (USA) or a roh'ie (Australia).

Flunitrazepam is currently a Schedule III drug under the international Convention on Psychotropic Substances of 1971; in the United States, it is on Schedule IV

According to FDA Associate Director for Domestic and International Drug Control Nicholas Reuter:

Flunitrazepam was "temporarily controlled in Schedule IV pursuant to a treaty obligation under the 1971 Convention on Psychotropic Substances. At the time flunitrazepam was placed temporarily in Schedule IV . . . there was no evidence of abuse or trafficking of the drug in the United States."

Rohypnol is currently under consideration to be rescheduled to Schedule I, and is already considered such in the States of Florida, Idaho, Minnesota, New Hampshire, New Mexico, North Dakota, Oklahoma, Pennsylvania, and Virginia.

21 U.S.C. § 841 and 21 U.S.C. § 952 provide for stiff prison terms for the possession of flunitrazepam; penalties for use or distribution include life in prison, should death or serious injury occur.

In Australia, flunitrazepam is a schedule 8 drug, along with amphetamines and narcotic analgesics. All other benzodiazepines (except Temazepam) are schedule 4 drugs. Unauthorized possession of certain quantities of the drug is punishable by criminal sanctions in New South Wales under Schedule 1 of the Drug Misuse and Trafficking Act 1985.

On January 1, 2003, flunitrazepam was moved up one level in the schedule of controlled drugs in Norway, and, on August 1, 2004, the manufacturer Roche removed Rohypnol from the market there altogether.

The Dutch, British and French use a system called the System of Objectified Judgement Analysis for assessing whether drugs should be included in drug formularies based on clinical efficacy, adverse effects, pharmacokinetic properties, toxicity and drug interactions. A Dutch analysis using the system found that flunitrazepam is unsuitable to be included in drug prescribing formularies.