In Australia, sleep problems are common in adults and affect 33% to 45% of the adult population.
Approximately one in five people are estimated to be affected by a major sleep disorder including narcolepsy, obstructive sleep apnoea (OSA), insomnia, restless legs syndrome (RLS), circadian rhythm disorders, and central disorders of hypersomnolence.
Modafinil, a prescription that promotes wakefulness and alertness is often used to treat symptoms like excessive daytime sleepiness caused by the above disorders.
Countries around the world have different rules and approaches to dealing with drugs. Some are straight forward, while others are hard to understand and difficult to follow. In Australia, the laws pertaining to therapeutic goods, especially prescription drugs like modafinil, are strict.
In this article, we will help you make sense of the rules that impact purchasing, importing, and using modafinil. We will also go over everything you need to know about how and where to buy the medication in Australia.
Table of Contents
- What Is Modafinil?
- How Does Modafinil Work?
- Off-Label Use of Modafinil
- Is Modafinil A Nootropic?
- Generic Vs. Brand Modafinil: What’s The Difference?
- Is Modafinil Legal In Australia?
- Australia’s Drug Scheduling System
- Buying Modafinil From A Pharmacy
- Buying Modafinil Online
What is Modafinil?
Modafinil is in a class of medications called wakefulness-promoting agents or eugeroics. The drug’s discovery dates back to the 1970s, and the medication was first marketed in Europe in 1992.
Modafinil is made for oral use and comes in the form of a white pill that is either round, capsule, or oblong/oval. Typically, the shape depends on the brand and dose. The medication is available in 100mg or 200mg strength. The recommended dose is 200 mg once daily not to exceed 400 mg, taken in the morning with or without food.
How Does Modafinil Work?
Modafinil is a central nervous system (CNS) stimulant. It has a similar mechanism of action to amphetamines, methylphenidate, cocaine, and caffeine. Unlike classic stimulants, however, modafinil is reported to have minimal side effects and low abuse potential. The drug also does not interfere with normal sleep and does not seem to produce tolerance.
Stimulants raise the levels of key chemicals (neurotransmitters) in the brain and other parts of the body. There are five main neurotransmitters associated with modafinil. They are histamine (HA), norepinephrine(NE), serotonin (5-HT), dopamine (DA), and orexin. Studies show that increasing the amounts of these chemicals in the brain speeds up both mental and physical processes like alertness, energy, and attention.
Modafinil is also thought to decrease a chemical called gamma-aminobutyric acid (GABA). GABA is an inhibitory neurotransmitter that slows the brain down by blocking or inhibiting certain brain signals. This naturally occurring amino acid also decreases activity in your nervous system.
Modafinil works without creating agitation, stimulation, or cardiovascular side effects common with other stimulants. The drug’s side effects are few and are more common among first-time users and people who exceed their therapeutic dose. The most common side effects of modafinil include headache, nausea, nervousness, anxiety, insomnia, and upper respiratory tract infections.
Off-Label Use of Modafinil
In recent years, prescriptions for modafinil have rapidly increased. Off-label or non-medical use of the drug is credited as the main driver. In medical terms, off-label refers to the use of a drug that is not studied as a part of the FDA approval process. This may also be referred to as “lifestyle” uses. Conditions now treated with the drug include the following:
- Age-related memory decline
- Attention deficit disorder
- Post-stroke fatigue
- High-pressure job-related fatigue
- Cancer-related fatigue following chemotherapy or radiation therapy
- Multiple sclerosis-related fatigue
- Fatigue experienced by people who need to be awake and alert for extended amounts of times such as soldiers, truckers or students cramming for finals
- Jet lag
- Alzheimer’ s-related memory problems and apathy
- Parkinson’s Disease
- Post-anesthesia grogginess
- Fatigue in lung cancer
- Prescription medication-related sleepiness
- Cocaine addiction
- Weight loss
Is Modafinil A Nootropic?
Nootropics, or “smart drugs,” are natural or synthetic substances that can boost brain performance in healthy people. They are sometimes called cognition enhancers or memory-enhancing substances.
Modafinil’s chemical and pharmacological properties have been clinically proven to have strong nootropic effects. Those properties have even earned the drug some interesting nicknames including “magic stimulant,” “limitless pill,” and “Viagra for the brain,”
The drug’s nootropic properties have made it increasingly popular with people who need help with fatigue, managing stress, and staying ahead of the competition. This includes financial traders, IT professionals, students, public servants, pilots, poker players, and card-counters, among others.
Generic Vs. Brand Modafinil: What’s The Difference?
Modafinil is the generic version of a drug that is also available under a host of different brand names. Although generic drugs are widely used, some customers look at them with skepticism. A common concern is whether these types of medications have the same quality as the name-brand version.
Legally, all approved generic and brand name drug versions must have the same active ingredients to ensure that the medication has the same medicinal effects. They are also required to pass the same quality standards regarding manufacturing and packaging. Trademark laws may prevent these types of medicines from having the same shape, color, packaging, flavorings, or inactive ingredients.
Brand Name Versions of Modafinil
In Australia, Modavigil, made by TEVA Pharmaceuticals, is a commonly available brand name version of modafinil. Others include the following:
- Modafil MD
Cost is one of the major attractions of using generic medicines. Generic drugs typically cost about 80% to 85% less than the same brand-name drug. For example, some pharmacies can charge between $53 to $78 per pill for Provigil or Nuvigil. By comparison, generic options for the same can range from $0.80 and $2.80 per tablet.
Another common reason for using generic instead of brand medications is allergies or intolerances. As mentioned earlier, both types of drugs have the same active ingredients but often different inactive substances. Users who have allergies to substances in one version can still get the benefits of using the medication by switching to a different brand.
Is Modafinil Legal In Australia?
Modafinil is legal in Australia and was first authorized for use in July 2002 by The Therapeutic Goods Administration (TGA). The TGA is a regulatory body that is part of the Australian Government Department of Health.
The primary role of the TGA is to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety, and performance. This regulatory body oversees both medicines and medical devices.
When modafinil was greenlit for use in 2002, the only treatment the medication was indicated for was for the improvement of wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.
Five years late in April 2007, the TGA allowed the use of modafinil for the treatment of excessive sleepiness associated with chronic shift work sleep disorder and obstructive sleep apnoea/ hypopnoea syndrome.
Australia’s Drug Scheduling System
To protect public health and safety, all medicines, controlled and prohibited drugs and poisons are categorized based on their level of risk both to the users and the preparer (if applicable). This system is called ‘scheduling’ and applies to all Australian states and territories.
The classifications and details pertaining to each are listed in The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). Each category addresses how medicines or poisons should be labeled, sold, bought, stored, and thrown away.
There are eight schedules included in the SUSDP, and they are as follows:
Schedule 1 (S1)
This schedule is not in use.
Schedule 2 (S2) – Pharmacy Medicines
Schedule 2 refers to substances and preparations for therapeutic use, and for which the safe use may require advice from a pharmacist or, where a pharmacy service is not available, from a licensed person. Pharmacy medicines in this category do not require medical diagnosis or management prior to provision.
In New South Wales, Schedule 2 substances are referred to as “medicinal poisons.”
Examples of Schedule 2 substances include the following:
- Nasal sprays containing decongestants or steroids
- Acetic acid
Schedule 3 (S3) – Pharmacist Only Medicine
Schedule 3 refers to substances and preparations for therapeutic use that are substantially safe in use, but the safe use of which requires professional advice, management, or monitoring. Should be available to the public from a pharmacist without a prescription.
In New South Wales, Schedule 3 substances are referred to as “potent substances.”
Examples of Schedule 3 substances include the following:
- Orlistat, Xenical
- Pseudoephedrine (found in Cold and Flu preparations)
- Salbutamol, Ventolin, Asmol
Schedule 4 (S4) – Prescription Only Medicine or Prescription Animal Remedy
Schedule 4 refers to substances and preparations that require professional medical, dental, or veterinary prescription and management or monitoring. Items in this category are only available from a pharmacist on prescription.
In New South Wales, Schedule 4 substances are referred to as “restricted substances.”
Examples of Schedule 4 prescription-only medicines include the following:
- Selective Serotonin Reuptake Inhibitor (SSRIs) – For Example, Citalopram (Celexa), Escitalopram (Lexapro), Fluoxetine (Prozac), Paroxetine (Paxil, Pexeva), and Sertraline (Zoloft).
- Serotonin and norepinephrine reuptake inhibitors (SNRIs) – For example, Desvenlafaxine (Pristiq), Duloxetine (Cymbalta), Venlafaxine (Effexor), Venlafaxine XR (Effexor XR), Milnacipran (Savella), and Levomilnacipran (Fetzima).
- Tricyclic antidepressants (TCAs) – For example, Amitriptyline, Amoxapine, Desipramine (Norpramin), Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline, and Trimipramine
- Monoamine oxidase inhibitors (MAOIs) – For example, Rasagiline (Azilect), Selegiline (Eldepryl, Zelapar), Isocarboxazid (Marplan), Phenelzine (Nardil), and Tranylcypromine (Parnate).
Schedule 5 (S5) – (Caution)
Schedule 5 refers to substances and preparations with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label. Items in this category must be kept out of direct access to the public and stored separately from foodstuffs or beverages.
Examples of Schedule 5 include the following:
- Acetic Acid (excluding its salts and derivatives) in preparations containing more than 30 percent of acetic acid
- Acetone except in preparations containing 25 percent or less of designated solvents
- Alkaline Salts
- Boric Acid (excluding its salts)
- Methylated Spirits
- Warfarin (in rodent baits)
- Turpentine Oil except in preparations containing 25 percent or less of turpentine oil.
Schedule 6 (S6) – Poison
Schedule 6 refers to substances and preparations with moderate to high toxicity. Accidental ingestion, inhalation, or in contact with skin or eyes may cause death or severe injury.
Examples of Schedule 6 substances include the following:
- Butyric Acid (insect lures)
- Aspirin (veterinary applications)
- Ammonia (refrigerant)
- Barium salts (manufacturing additive)
- Formaldehyde (excluding its derivatives) in preparations containing 0.05 percent or more of free formaldehyde
Schedule 7 (S7) – Dangerous Poison
Schedule 7 refers to substances and preparations with high to extremely high toxicity, which can cause death or severe injury at low exposures. The items in this category require special precautions in their manufacture, handling, or use. They also have special regulations restricting their availability, possession, or use are necessary.
Examples of Schedule 7 Substances include the following:
- Dichlorodiphenyltrichloroethane (DDT)
Schedule 8 (S8) – Controlled Drug – Possession without authority illegal)
Schedule 8 are substances and preparations for therapeutic use, which have a high potential for abuse and are likely to cause dependence.
In New South Wales, Schedule 8 substances are referred to as “drugs of addiction.”
Examples of Schedule 8 substances include the following:
- Barbiturates (most)
- Codeine (single ingredient)
- Gamma-hydroxybutyrate (GHB)
Schedule 9 (Prohibited Substance)
Schedule 9 are substances and preparations which may only be used for research purposes. The sale, distribution, use, and manufacture of such substances are strictly prohibited.
Examples of Schedule 9 substances include the following:
- Cannabis (except when separately specified in other Schedules)
- Coca leaf
- N, N-Dimethyltryptamine (DMT)
- 2,5-dimethoxy-4-bromophenethylamine (2C-B)
- 3,4-Methylenedioxymethamphetamine (MDMA)
- Methylenedioxypyrovalerone (MDPV)
- Mitragyna speciosa
- Lysergic acid diethylamide (LSD)
- Salvia divinorum
Schedule 10 (S10) – Dangerous Substances (previously Appendix C)
Schedule 10 refers to substances that are considered extremely dangerous to health. Items in this category are prohibited from sale, supply, and use.
Examples of Schedule 10 substances include the following:
- Borage (therapeutic use)
- Coal tar (cosmetic use)
- Juniperus sabina (therapeutic use)
- Oxyphenisatin (therapeutic use)
Buying Modafinil From A Pharmacy In Australia
One way to buy modafinil in Australia is to buy it from a local pharmacy. As this medication is a Schedule 4 (S4) drug, you need a prescription from a doctor in order to buy it from a pharmacy. Getting a prescription can be a long process, as diagnosing sleep disorders requires several tests.
Typically, most patients have to undergo an overnight sleep study and a Multiple Sleep Latency Test (MSLT). Doctors will also perform a physical exam and an in-depth medical history to rule out other potential causes of daytime tiredness.
Once you receive a prescription, you can walk into a pharmacy and buy the medication. Some Australian pharmacies even let you buy modafinil online if you mail in a copy of your prescription.
Buying modafinil from a pharmacy is often a costly option as they generally only have brand name versions of the drug available. Your choices may also be limited to only a few brand versions.
Buying Modafinil Online
In Australia, a large number of Modafinil users prefer to buy the medication online. Most modafinil purchased online comes from Indian manufacturers and distributors e.g., Sun Pharmaceuticals and HAB Pharmaceuticals.
These companies sell the drug to different vendors all around the world. As manufacturing costs are low in India, online sellers are able to offer medicines like modafinil at a fraction of the cost of brand-name versions. They also don’t require a prescription as modafinil can be bought over the counter in India.
With the use of smart drugs like modafinil growing in popularity, the number of online vendors is on the rise. You can buy this medication safely online if you do your due diligence to find a reputable vendor.
Buying Modafinil Online That Ships To Australia
Under Australia’s personal importation scheme, Schedule 4 (S4) medicines can be imported into the country if they meet certain criteria.
One criterion is that none of the ingredients in the drug are listed on the Office of Drug Control’s list of controlled and prohibited substances.
Modafinil is not on that list, so you can buy the drug from online distributors located outside Australia. This option is still subject to some restrictions put in place by the TGA. The TGA states that a prescription is required and should be enclosed with the package the medicine is sent in. If the Australian Border Force (ABF) seize your item and don’t find a prescription, it will be held until you provide on. Failure to do so results in the package being destroyed.
Additionally, the drug can only be imported for personal use or for an immediate family member. Also, you can only import a 3 month supply in one order, and no more than 15 months of supply over 12 months.
Many people prefer buying modafinil using this option as the prices are more affordable. Some online vendors, even offer additional discounts on top of already low prices as well as more drug options to choose from.
In Australia, modafinil is Schedule 4 (S4) prescription-only medication. The drug is available in pharmacies with a prescription or can be bought online. Under the personal importation scheme, you can import a 3 month supply in one order, and no more than 15 months of supply over 12 months for yourself or an immediate family member.
The TGA requires that all imported prescription medications be accompanied by a prescription. If The Australian Border Force searches your package and don’t find one, it will be held until you can provide one; otherwise, it will be destroyed.
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