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Modafinil

 
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UK's Lowest Price and only Registered UK Online Doctor Service Dispensing Modafinil.

What is Modafinil?

Modafinil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy.

Modafinil is a typical drug that is used to treat sleep-related problems such as narcolepsy, work- related sleep disorders, or excessive sleepiness in the morning. This drug is also commonly used for problems associated with obstructive sleep apnea. Narcolepsy is different from just being sleepy as the former is a real disorder while the latter usually results from sleepless nights and fatigue. In most cases, people who suffer from narcolepsy tend to fall asleep anywhere without warning which poses real-life dangers.

How To Take

Modafinil should be taken once a day orally. It can be taken with or without food. It is recommended to check with your doctor, if there are any time preference when you better take it. Usually Modafinil is taken in the morning.

If you use Modafinil for the treatment of shift work disorder then you better take it an hour before you start your shift. Better to take Modafinil at the same time, if possible, and only change that after consulting your doctor.

Modafinil will only help to reduce sleepiness, but it will not treat your condition, therefore you need to continue taking Modafinil even if you feel rested.

More information

Brand Names to Look for
In English-speaking places, the drug is commonly sold under various brand names like Alertec, Provigil, and Modavigil. In the US, Modafinil is a schedule IV controlled substance which means that a person wanting to buy the drug will need a prescription to buy it. It is a heavily regulated and controlled substance since it has the potential to become addictive. Aside from that, however, it is not legally restricted and can easily be bought if you have the needed prescription.

Mode of Action
Its mode of action used to be a mystery but modern findings suggest that it acts as a very weak and selective atypical dopamine reuptake inhibitor as it behaves similarly to other drugs in this classification. There is a lot of evidence to support the claim; however, it is also thought that there are actually a lot more mechanisms at work.

As mentioned, Modafinil is linked with narcolepsy which makes it a good treatment option for narcolepsy and other sleep related problems and disorders. Since there is a huge risk for developing hypersensitivity reactions and neuropsychiatric disorders when taking the drug, the European Medicines Agency recommends in limiting the prescription of the drug to patients who suffer from narcolepsy only.

Contraindications to Modafinil Use
Similar to other medications and drugs, the first and foremost contraindication to its use is allergy and hypersensitivity. In the case of modafinil, it is the only contraindication for its use. However, Cephalon has distributed literature advising that it is still important to consult a physician before taking the drug as people may experience problems related to hypersensitivity to constituents of the tablet. People who suffer from cirrhosis can also have problems with the drug as their condition may impair the metabolism of modafinil. Of course, people with cardiovascular problems are always susceptible to problems brought on about certain drug interactions especially those that have an effect on the nervous system and neurotransmitters.

Adverse Effects
Just like any drug and medication, modafinil affects people differently and may show adverse reactions that aren’t beneficial to the person. As with any drug, the effects may or may not appear on a particular person which is why it requires proper clinical studies and trials. Teva Pharmaceuticals provides documentation about the adverse effects of the drug. According to their clinical trials, 1/3 of their participants have experienced headaches when taking the drug while 11% suffered from nausea. Other side-effects that participants experienced includes: diarrhoea, nervousness, insomnia, dizziness, and GI problems although these problems were only experienced by less than 10% of the participants.

 There are also the very rare cases of severe adverse effects such as severe skin rashes or other allergy-related symptoms. From December 1988 which was the date of the drug’s initial marketing up to the end of January 2007, the US FDA has received only six cases of severe cutaneous adverse reactions. These include the following skin reactions: SJS, Erythema Multiforme (EM), TEN, and DRESS. These affected both adults and paediatric patients. Because of this the FDA needed to issue an alert regarding the medication and they also noted that multi-organ hypersensitivity and angioedema has been reported in postmarketing. This prompted the FDA to order Cephalon to change their Provigil leafleat with a bold-face print of some serious and potentially fatal adverse effects such as TEN (toxic epidermal necrolysis), SJS (Stevents-Johnson Syndrome), and DRESS.

When it comes to long term effectiveness and safety, its effects haven’t been determined. It is thought that modafinil may have adverse interactions on hormonal contraception which can last for more than a month after the last modafinil dose. But all medications can be un-safe make sure you consult a doctor before taking any medication.

Potential for Dependence and Addiction
When it comes to the potential for being an addictive substance, the chances for modafinil are incredibly low. It does, however, share some biochemical mechanisms with other stimulant drugs that are addictive. According to some studies, the drug shows very similar mood-elevating properties but significantly less. Monkeys will mostly self-administer if they have been trained to self-administer cocaine. The drug doesn’t display a reinforcing effect when tested on mice that are given the therapeutic human dose although it does show a little effect when given higher dosages. Although it is very rare, there are cases that show modafinil abuse does exist. This is partly the reason why the drug is considered as a schedule IV controlled substance in the US. This category is reserved for medication that has a valid medical reason to be used and has a low but still significant addictive potential.

Very little psychological dependence has been recorded with the drug  and the only known cases have been reported in conjunction with daily overdose for extended periods. There are, however, reported withdrawal symptoms like lethargy, anhedonia, insomnia, and anxiety.

Developing Tolerance
There have been extensive clinical studies done about the subject and, so far, there is no evidence that shows that people using modafinil will develop tolerance when taking the drug at therapeutic doses even when used for a long period lasting for 40 weeks to three years.

Overdosing in Modafinil
When tested on rats, the median letal dose was approximated to a little bit above 1250 mg/kg. The median dose reported for oral dosages on rats was reported to be 1000-3400 mg/kg. IV median dosage for dogs, on the other hand, was at 300 mg/kg. Clinical trials done for humans were done at 1200 mg./day ranging from 1 week to three weeks. There is a reported one-time case of overdose up to 4500 mg but it didn’t cause any life-threatening effect. It did result in a lot of adverse reactions such as insomnia, agitation, aggressiveness, irritability, nervousness, confusion, palpitations, tremors, nausea, sleep disruptions and diarrhoea. The FDA maintains its stand that there is no fatal overdose associated with modafinil use although it is for modafinil only drugs as multiple ingredient drugs including modafinil aren’t included in the assumption.

Drug to Drug and Other Interactions
Taking modafinil with other opiods like hydrocodone, fentanyl, and oxycodon can result in a drop of plasma concentration in the body. This is because modafinil is largely dependent on CYP3A4 enzyme. If not monitored, this can cause reduced effectiveness and withdrawal symptoms.

The drug’s effectiveness is largely dependent on the status of catechol-O-methyl transferase or COMT in the body. This is the one responsible for the improvement in vigour and energy during sleep deprived moments. Some studies are suggesting that people with Val/Val genotype will experience an even greater cognitive improvement in taking the drug while those who have Met/Met genotyping will experience little improvement.

History of the Drug
The drug was primarily developed in France by the emeritus experimental medicine professor and neurophysiologist Michel Jouvet at Lafon Laboratories. The drug was first developed in the late 1970s during the invention of a series of benzhydryl sulfinyl compounds. This includes adrafinil and was offered as an experimental treatment option for narcolepsy back in 1986. Modafinil came into being since it was the primary metabolite of the aforementioned drug. It lacked the –OH group on the last amide which gives it a similar effect to the parent drug but has greater use. It has been used in France since 1994 under the brand name Modiodal.

On the other hand, it has been in use in the US since 1998 under the brand name Provigil. The US FDA approved the drug for narcolepsy treatment during this year and alter added in 2003 to treat obstructive sleep apnea and shift work related sleep disorder. This was added even though studies have shown that amphetamines and caffeine have proven to be more effective in promoting narcolepsy based on the Stanford Sleepiness Test Score. It is marketed by Cephalon Inc in the country as they originally leased the rights from Lafon before buying the company back in 2001.

Cepahlon started marketing the R-enantiomer armodafinil form of modafinil in the US in 2007. Generic versions of the drug became available in 2012 due to a protracted patent litigation.

In the United Kingdom, the drug was first approved in December 2002.

When it comes to sports, the use of the drug is somewhat controversial as high-profile cases attract a lot of press coverage. There are a lot of prominent athletes in the US that have tested positive for the drug. They protested that modafinil doesn’t belong to the prohibited list at the time. However, the WADA or World Anti-Doping Agency maintains that even if the drug itself isn’t in the banned list, it is still related to already banned substances. This prompted them to add the drug to the list of prohibited substances on August 3, 2004—ten days prior to the start of the 2004 Summer Olympics.

You should check with your doctor immediately if any of these side effects occur when taking modafinil:

Less common:
  • Black, tarry stools
  • blurred vision or other vision changes
  • chest pain
  • chills or fever
  • clumsiness or unsteadiness
  • confusion
  • dizziness or fainting
  • increased thirst and urination
  • mental depression
  • problems with memory
  • rapidly changing moods
  • shortness of breath
  • sore throat
  • trembling or shaking
  • trouble in urinating
  • uncontrolled movements of the face, mouth, or tongue
  • unusual bleeding or bruising
  • unusual tiredness or weakness

If any of the following symptoms of overdose occur while taking modafinil, get emergency help immediately:

Symptoms of overdose:
  • Agitation or excitement
  • fast or pounding heartbeat
  • increased blood pressure
  • trouble with sleeping

Severity: Minor

More common:
  • Anxiety
  • headache
  • nausea
  • nervousness
Less common:
  • Back pain
  • belching
  • decrease in appetite
  • diarrhea
  • difficulty having a bowel movement
  • dryness of the mouth
  • dryness of the skin
  • feeling of constant movement of self or surroundings
  • flushing or redness of the skin
  • heartburn
  • indigestion
  • muscle stiffness
  • sores, ulcers, or white spots on the lips or in the mouth
  • sour stomach
  • stomach discomfort upset or pain
  • stuffy or runny nose
  • swelling
  • tingling, burning, or prickling sensations in the skin
  • vomiting

with your doctor immediately if any of these side effects occur when taking modafinil:

Less common:
  • Black, tarry stools
  • blurred vision or other vision changes
  • chest pain
  • chills or fever
  • clumsiness or unsteadiness
  • confusion
  • dizziness or fainting
  • increased thirst and urination
  • mental depression
  • problems with memory
  • rapidly changing moods
  • shortness of breath
  • sore throat
  • trembling or shaking
  • trouble in urinating
  • uncontrolled movements of the face, mouth, or tongue
  • unusual bleeding or bruising
  • unusual tiredness or weakness

If any of the following symptoms of overdose occur while taking modafinil, get emergency help immediately:

Symptoms of overdose:
  • Agitation or excitement
  • fast or pounding heartbeat
  • increased blood pressure
  • trouble with sleeping

Severity: Minor

More common:
  • Anxiety
  • headache
  • nausea
  • nervousness
Less common:
  • Back pain
  • belching
  • decrease in appetite
  • diarrhea
  • difficulty having a bowel movement
  • dryness of the mouth
  • dryness of the skin
  • feeling of constant movement of self or surroundings
  • flushing or redness of the skin
  • heartburn
  • indigestion
  • muscle stiffness
  • sores, ulcers, or white spots on the lips or in the mouth
  • sour stomach
  • stomach discomfort upset or pain
  • stuffy or runny nose
  • swelling
  • tingling, burning, or prickling sensations in the skin
  • vomiting

Read more here

Please read the patient information leaflet available
here

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