Legal Status of Modafinil
Modafinil is a world-known and appreciated wakefulness-promoting agent that is used to treat numerous conditions, such as narcolepsy, excess daytime sleepiness, shift work sleep disorders, obstructive sleep apnea and other related complications. Additionally, the drug is actively used to improve physical performance, boost endurance and stamina, as well as keep the body toned.
Being an extremely popular and widely demanded medicine, Modafinil is available online. Though, the question remains the same: Is Modafinil legal in your country? Considering the issue, it is necessary to remember the differences in the laws of diverse countries, since Modafinil status will depend on it.
Currently, the remedy is approved by the US federal law as a prescription medication that belongs to a group of Schedule IV controlled substances. According to the regulations, no one except of DEA-registered distributors can import the medication without a prescription.
Nevertheless, it is allowed to bring the medication into the USA in case a person has a prescription and the drug is properly declared. Based on Food and Drug Act of the US, Modafinil cannot be legally sold for off-label use.
Countries Where Modafinil is not a Controlled Substance
Contrary to the USA, there is a number of countries that do not share the classification of Modafinil. This group consists of:
- Canada. The medication belongs to Schedule F prescription medication, but is not mentioned in Controlled Drug and Substance Act.
- Germany. Since March 2008, the legal status of the drug has been changed from controlled substance to prescription medicine.
- Mexico. Modafinil is not registered as a controlled substance.
- UK. A prescription is required for Modafinil purchase.
- Australia. The medication is classified as a Schedule IV prescription drug.
- India. Prescription is not necessary, since generic Modafinil variant is available.
- Considering Modafinil usage in sport, the drug was banned in 2003 by the World Anti-Doping Agency due to its powerful effect on physical performance of athletes.
Since the medication is legally accessible in various countries, it is necessary to be aware of different Modafinil brand names that include Provigil, Vigil, Modiodal, Modasomil, Provake, Alertec, Resotyl, Vigia and multiple others.
Modafinil in the USA
Modafinil is an international non-proprietary name of the drug to treat sleep disorders, possessing pharmacological property to suppress excessive sleepiness. Modafinil medication was developed by French pharmaceutical company Lafon Group (today a part of the company Cephalon).
In 1998, the FDA approved Modafinil for narcolepsy treatment and this medication entered the market under the trade name Provigil on the U.S. pharmaceutical market.
Today in the USA Provigil (Modafinil) medication is prescribed for adults (over 18 years) to prevent the attacks of excessive sleepiness, caused by: narcolepsy, obstructive sleep apnea or shift work sleep disorder.
In 2007, the FDA published information that the use of Provigil (Modafinil) pills can cause the development of severe side effects, including: skin allergic reaction (skin rash, itching); sores in the mouth, yellowing of the skin or eyes, fever, pain when swallowing and breathing.
If one of the above-listed side effects is observed in patient, it is necessary to stop taking Provigil (MMM) pills and to consult professional health care provider.
Manufacturers and suppliers of Modafinil pills in the USA
Taking into the account in 2014, the validity of patent protection for the invention of psychostimulant Modafinil expires, company Cephalon* will lose exclusive rights to sell it in the USA.
This means that in 2014, the monopoly of company Cephalon for Modafinil pills sale will be broken in the USA, herewith the company Cepalon* will remain the sole owner of the trade name Provigil.
Since 2014 Provigil generics will be available in sale on the U.S. pharmaceutical market, they will be marketed under the generic name Modafinil.
Pharmaceutical companies, received a prior FDA approval to sell Modafinil pills in the USA, are:
- Mylan Pharmaceuticals Inc.; Ranbaxy Laboratories Limited; Teva Pharmaceutical Industries LTD; Barr Laboratories Inc.; Carlsbad Technologies Inc.; Sandoz Pharmaceuticals; Apotex Inc.; Caraco Pharmaceutical Labs Ltd; Orchid Chemicals and Pharmaceuticals Ltd.
At our online pharmacy you can make the purchase of Modafinil pills online from any country worldwide. So, psychostimulant Modafinil will be sent you together with the medical prescription by post.
Only the presence of prescription will provide unimpeded passage of Modafinil pills through the customs control zone and will guarantee a timely delivery of psychostimulant Modafinil to the indicated address.
*In October, 2011 the company Cephalon (owner of the trade name Provigil) became a part of one of the world’s largest manufacturers of generic drugs – the company Teva Pharmaceutical Industries Ltd.
Modafinil in NZ
Modafinil tablets are administered to improve wakefulness in people with excessive daytime sleepiness, caused by narcolepsy, obstructive sleep apnea or shift work sleep disorder.
On the pharmaceutical NZ market, Modafinil tablets entered the market under the trade name Modavigil in July, 2004 (Medsafe approval date: July 22, 2004).
- Pharmaceutical company Cephalon Inc. is a developer of Modafinil drug to treat sleep disorders and a supplier of trade name Modavigil.
- Official distributor of Modavigil tablets is company CSL Biotherapies (NZ) Limited on the pharmaceutical NZ market.
- In NZ one can buy Modavigil (Modafinil) drug to treat sleep disorders in tablet form for oral administration. Each Modavigil tablet contains 100mg of active substance Modafinil.
- In New Zealand pharmacies you can buy Modavigil 100mg tablets in blister packaging (of 10, 30, 60 and 90 pcs in one package).
Modafinil tablets in modern clinical practice
Modafinil tablets are prescribed for patients with narcolepsy to prevent attacks of sleepiness.
Narcolepsy is a chronic sleep disorder, characterized by excessive sleepiness during the day, even if a person had normal night sleep.
In narcolepsy treatment, it is recommended to take one tablet Modafinil 100mg in the morning and one tablet Modafinil 100mg in the daytime.
Maximum daily dosage of Modafinil, prescribed to patients with narcolepsy should not exceed 400mg. It is not recommended to take Modafinil tablets in the afternoon or in the evening, since insomnia may develop due to the taking of Modafinil tablets at bedtime.
It is recommended to use Modafinil tablets in the evening only when treating shift work sleep disorder (SWSD).
To avoid the episodes of excessive sleepiness during working hours (night shift), it is recommended to take 2 tablets Modafinil 100mg in a single dose, 1-1½ hour before the work shift begins.
Taking Modafinil tablets before the start of shift work, patient with SWSD will not experience the feeling of drowsiness and will be able to remain vigilant and maximum concentration when performing the professional duties.
Patients taking Modafinil drug for the treatment of pathological sleep disorders should be warned that:
- Modafinil does not compensate the lack of sleep;
- Modafinil does not remove physical fatigue;
- Modafinil cannot be prescribed to treat sleep disorders in children under 18 years.
If you decide to buy Modafinil without prescription but have never taken this drug to treat sleep disorders, please apply to our pharmacist for a qualified consultation. At our online pharmacy you can order Modafinil online and get a free pharmacist’s consultation from anywhere in the world.
Modafinil in EU
In EU Modafinil drug to treat sleep disorders first came on the market in 1992.
Today you can buy Modafinil medication in 21 EU countries, including:
- Germania, France, Greece, Sweden, Spain, Luxembourg, Austria, Hungary, Italy, Belgium, Iceland, Poland, Cyprus, Finland, Czech Republic, Ireland, Slovakia, Portugal, Denmark, Netherlands and the UK.
In EU member states, Modafinil medication for the treatment of chronic sleep disorders goes on sale under trademarks: Provigil, Modasomil, Vigil and Modiodal.
Indications for Modafinil use in EU
Until 2010 Modafinil medication was prescribed to treat narcolepsy, shift work sleep disorder and idiopathic hypersomnia in EU member states.
As part of combination therapy Modafinil medication was administered to treat obstructive sleep apnea.
In 2010 European Medicines Agency (EMA) recommended professional medical community to prescribe Modafinil medication only for narcolepsy treatment.
According to the results of clinical studies, EMA has concluded that therapeutic benefit from Modafinil pills use does not exceed potential risk for the patient’s health in the treatment of idiopathic hypersomnia, obstructive sleep apnea and shift work sleep disorder.
Possible Modafinil side effects
Prolonged use of Modafinil medication in maximum daily dose 400mg increases the risk of severe side effects, including symptoms development:
- Severe mental disorders (suicidal thoughts, mania, delirium, psychosis);
- Allergic skin reactions (itching, rash, skin redness);
- Stevens-Johnson syndrome;
- Сardiovascular reactions (high blood pressure and irregular heartbeat).
In children the risk of severe side effects is significantly higher than in adults. Thus, taking of Modafinil pills is contraindicated for patients younger than 18 years.
If you have prescribed psychostimulant Modafinil (In EU – Modasomil; Provigil; Modiodal; Vigil) but it is expensive in your city pharmacies, you can order the delivery of cheap Modafinil pills at our online pharmacy. When buying a big package of Modafinil pills online at our online pharmacy you can get a discount which will compensate your costs for the payment of postal service.
Modafinil in Canada
Modafinil is a medication for the treatment of sleep disorders in adults, is marketed under different trademarks. In 1999, Modafinil drug came into the market under the trademark Alertec on the pharmaceutical Canadian market.
The right holder of Alertec trademark and developer of molecular formula Modafinil medication is company Cephalon. In Canada you can buy Alertec (Modafinil) for chronic sleep disorders in tablets for oral use.
Despite the fact that Alertec pills are produced by company Cephalon, a trade license for their sale has been granted to pharmaceutical company Shire Canada Inc. (official distributor of Alertec pills).
In the period from 1999 to 2008, the sale of Modafinil drug is carried out only under the trademark Alertec in Canada.
In 2008, Alertec generic under the generic name Modafinil became available in Canada.
As well as Alertec pills, Modafinil pills are sold in 100mg dosage in Canadian pharmacies.
Pharmaceutical company Apotex Inc. is a manufacturer of Modafinil pills.
Company AA Pharma Inc. is a supplier of Modafinil pills (generic Alertec) on Canadian pharmaceutical market.
Alertec and generic Alertec
Generic Alertec is a biopharmaceutical analog of Alertec medication. Trade name, package design and price are the only differences between generic Alertec pills and Alertec pills.
Generic Alertec is marketed under the generic name Modafinil in Canadian pharmacies. Herewith, it should be noted that price for Modafinil pills is significantly lower than the price for Alertec pills.
Generic Alertec pills (Modafinil pills) have gone on sale after the expiration of patent protection for the invention of molecular formula of active pharmaceutical ingredient Modafinil.
Given that company-manufacturer of generic Alertec did not invest in the invention of molecular formula Modafinil, the cost of generic Alertec (Modafinil pills) is significantly lower than the cost of Alertec pills.
Efficacy and safety of generic Alertec have been confirmed by the results of large-scale clinical and postmarketing studies. According to the results of numerous clinical studies, generic Alertec (Modafinil medication) was approved by Health Canada: May 1, 2008.
It should be noted that in children under 18 years the use of Alertec pills and Modafinil pills can cause allergic reactions, including skin rash, angioedema and anaphylactic reaction (swelling of face, eyes, lips, tongue or throat; hoarseness; difficulty breathing or swallowing).
That is why, Alertec pills and Modafinil pills can be used only in adult patients to treat: narcolepsy, obstructive sleep apnea and shift work sleep disorder.
Modafinil medication in modern clinical practice
In narcolepsy treatment, Modafinil drug:
- Suppresses drowsiness, preventing sudden sleep attacks;
- Reduces the likelihood of short-term paralysis of the body immediately after awakening;
- Reduces the risk of hallucinations while falling asleep and waking.
- Patients taking Modafinil for narcolepsy treatment should remember that Modafinil does not prevent the sudden loss of muscle tone (catalepsy).
Modafinil for obstructive apnea treatment
Given that the use of Modafinil pills help to keep a continuous positive airway pressure, Modafinil pill can complement the CPAP therapy.
Simultaneous use of Modafinil pills and CPAP therapy improves the effectiveness of therapeutic treatment of obstructive sleep apnea.
Modafinil for the treatment of shift work sleep disorder
Modafinil use to treat shift work sleep disorder suppresses the excessive feeling of drowsiness in people, working at night. Taking Modafinil pills allows the patient to be awake at the moment when physiological processes in the body promote occurrence of excessive sleepiness attacks.
Before to order Modafinil online, please learn the information about contraindications for this medication use for sleep disorders treatment. We want to draw your attention to the fact that you can seek to our pharmacist for a qualified advice and ask him all questions interesting you before to buy Modafinil online.
Modafinil in Australia
Since 2007, Modafinil medication to treat sleep disorders has been available under the trade name Modavigil on the Australian pharmaceutical market. Modafinil medication is produced by the pharmaceutical company Cephalon Inc. which is the right holder of the trade name Modavigil.
In Australia a distributor of Modavigil (Modafinil) medication is biopharmaceutical company CSL Limited (CSL). Company CSL Limited (CSL) develops, produces and supplies biopharmaceutical product in many world countries, including: Australia, the USA, Germany and Switzerland.
In Australia you can buy Modavigil medication in tablet form for oral administration.
One Modavigil pill contains 100mg of active pharmacological substance Modafinil.
In Australian pharmacies oral tablets Modavigil 100mg are marketed in blister package (10, 30 and 60 Modavigil tablets in one package).
In addition to Modavigil tablets, Australian pharmacies also sell another Modafinil-containing drug – MODAFIN.
Tablets of MODAFIN 100mg are a generic version of Modavigil 100mg tablets. The Australian supplier of Modavigil generic (MODAFIN) is Arrow Pharma Company.
If you decide to buy Modafinil or Modavigil generic with no prescription, please learn the contraindications for its use before you place an order. Pay attention the fact that all visitors of online pharmacy may take the advantage of a qualified pharmacist’s consultation.