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Product Information

Modafinil increases alertness and concentration (Alertec / ProVigil / Modiodal)

What is Modafinil?

Modafinil is a mind and mood enhancing stimulant that is not addictive, does not affect sleep and has no adverse side effects. What makes Modafinil unique is that it works only when stimulation is required. That means none of the “highs and lows” associated with other stimulants such as amphetamine.

Modafinil is an eugeroic drug, which simply means “good arousal”. Typical comments by initial users are “I can’t tell any difference” – so subtle is the affect. It is only several hours later when they realise they are still awake and alert, that they are aware of the benefits.

Modafinil not only enhances alertness and vigilance, it is also beneficial in improving memory and concentration. It will not affect your normal sleep patterns, nor will it bring about the anxiety or agitation associated with more familiar stimulants.

For people who have difficulty staying alert and awake during the day, the use of “classic” stimulants, such as amphetamines often reduces the amount of total sleep they are able to achieve, meaning ultimately higher and higher doses are required. Modafinil, on the other hand, does not interfere with nighttime sleep and, therefore, does not create this sort of vicious circle.

Modafinil is also known under brand names including Alertec, ProVigil and Modiodal.

How does Modafinil work?

Modafinil is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.

Modafinil uses a different mechanism to other stimulants, which cause significant changes in the release of dopamine in the brain. These changes are likely to account for the mood enhancing properties associated with these drugs, but also for the negative side effects such as jitteriness, insomnia and addiction.

In contrast Mondafinil induces wakefulness, it appears, by only stimulating the brain’s alpha-1 receptors - which are responsible for the body’s uptake of nor-adrenaline - whilst having a weak action towards the release of dopamine. This low dopamine-releasing action, makes the chances of a euphoric response, dose-dependency or drug tolerance very unlikely.

What is Modafinil used for?

Modafinil is primarily approved for the treatment of narcolepsy (a malfunction of the sleep/wake regulating system in the brain and characterized by uncontrollable bouts of daytime sleep), obstructive sleep apnea (a sleep disorder characterized by pauses in breathing during sleep) and shift work sleep disorders.

It is widely used to suppress the need for sleep and combating general fatigue. It is popular with people suffering from Chronic Fatigue Syndrome and also depression, since it reduces tiredness and boosts mood.

Is Modafinil beneficial for anything else?

Experimentally, Modafinil is being used in the treatment of:

• Alzheimer’s disease
• Age-related memory decline
• Depression
• Attention-deficit disorder
• Myotonic dystrophy
• Multiple sclerosis-induced fatigue
• Post-anaesthesia grogginess
• Cognitive impairment in schizophrenia
• Spasticity associated with cerebral palsy
• Idiopathic hypersomnia
• Jet-lag
• Cat-napping

How effective is Modafinil?

Studies directly comparing the affects of Modafinil and d-amphetamine on sleep have shown that d-amphetamine causes a dose dependant impairment of sleep, where as Modafinil does not.

One trial in particular, carried out in 1989 by Saletu, Frey and others and examining Modafinil and d-amphetamine, described amphetamine as “vigilance increasing” but Modafinil as “vigilance promoting.” The difference being that Modafinil will not prevent you from sleeping if you want to, but it will help you remain awake with far greater alertness.

Modafinil was put through its paces during a 60 hour sleep depravation trial carried out by Lagarde, Batejat and others in 1995. During the trial, a group of volunteers were given either Modafinil or a placebo and assessed for vigilance using a series of questionnaires and tests. Modafinil users were found to sustain a satisfactory level of vigilance with an absence of sleep episodes, while the placebo group gradually declined and slipped into bouts of ‘micro sleep’ (a brief loss of attention – of which the subject is often unaware - when they’re tired but trying to stay awake).

A three year French study by Bastuji and Jouvet examining Modafinil’s effect on the treatment of profound sleep conditions hypersomnia and narcolepsy, found that it reduced drowsiness in 83 per cent of hypersomniac patients and 71 per cent of narcoleptics.

A number of other studies have affirmed this finding and Modafinil’s effectiveness in the treatment of both narcolepsy and hypersomnia, and the weakness and fatigue condition catoplexy.

What is the dosage?

Modafinil comes as a tablet to take by mouth. It is usually taken once a day – shortly after waking – with or without food. If you are taking Modafinil to treat shift work sleep disorder, you should take it one hour before the beginning of your shift. Take Modafinil at the same time every day – do not change the time of day without talking to your doctor.

A single dose of 200mg is the usual initial dosage, which may be increased up to 400mg a day if necessary. You may need to divide the total dose over two or more smaller doses for ultimate effectiveness throughout the day. If you are over 65 years of age, it is recommended you start therapy at 100mg daily.

If you forget to take a dose of Modafinil, take the next dose at the usual time. Never take a double dose.

Are there any side effects or contraindications with modafinil?

So long as you follow your doctor’s instructions, taking Modafinil should produce no undesirable effects. If you do experience episodes of nervousness, excitation, aggressive tendencies, insomnia, anorexia, headaches, dry mouth, palpitations or gastrointestinal discomfort, make sure you are following the instructions for taking Modafinil correctly.

If you are pregnant or breast-feeding, you should not take Modafinil. If you suffer from hypertensivity, your blood pressure and heart rate should be monitored. If you have a history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestation of prolapse of the mitral valve associated with the use of CNS stimulants you should not take Modafinil.

If you are taking oral contraceptives, while being treated with Modafinil, you should take a product containing 50mg or more of ethinyl oestradiol to ensure their efficacy is not compromised.

Modafinil is not recommended for children.

Time to improve your memory

Traditional central nervous system stimulants, including amphetamines, have been used to treat narcolepsy, hypersomnia and cataplexy.  However, they have a number of well documented side effects, such as cardiovascular problems, sleep disturbances, psychiatric episodes and addiction.

Modafinil has the ability to stimulate only when stimulation is required. As a result, there are neither ‘highs and lows’ commonly associated with ingesting other stimulants, nor are there the common side effects of anxiety, agitation and insomnia.

Modafinil achieves wakefulness, in part, by interacting with the anterior hypothalamus, which stimulates alpha-1 brain receptors that are responsible for the uptake of nor-adrenaline. Its action of releasing dopamine is gentle and dose-dependent; therefore a euphoric response, dose-escalation or drug tolerance is very unlikely.

Certain human trials have used Modafinil as a therapeutic agent to help maintain alertness, and promote vigilance.  It will not prevent a person from sleeping when sleep is desired, but will support increased mental clarity during waking hours.

Modafinil is being used successfully to treat a number of neurological aging diseases including narcolepsy, Alzheimer's Disease, depression, Attention-Deficit Disorder, Myotonic Dystrophy, Multiple Sclerosis-induced fatigue, post-anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with Cerebral Palsy, and age-related memory decline.  It is also widely used by the armed forces to keep troops awake and alert.
08/22/2007 GI.

As with any other active pharmaceutical product, Modiodal may produce side effects, which can vary in their intensity, depending on the patient's reaction. Should you have any query, do not hesitate to consult your doctor.

CHEMICAL: Alertec and excipients- Lactose, maize starch, magnesium monosilicate, sodium croscarmellose polyvidone, magnesium stearate and talc.

RECOMMENDATIONS: For the treatment of narcolepsy (with or without cataplexy), idiopathic hypersomnia.

WARNING: If you are suffering from a heart condition, it is essential that you consult your doctor. Athletes should be aware that one of the main ingredients of this pharmaceutical product would produce a positive result in anti-doping tests.

PRECAUTIONS: Do not use this product if you are pregnant or nursing.

CONTRACEPTION: Use only normal dosage oral contraceptives or other contraceptive devices. Do not use low dosage oral contraceptives. In the event of serious liver diseases, consult your doctor. In order to avoid possible interactions among several pharmaceutical products; do not neglect to inform your doctor concerning any other treatment you might be receiving. Keep this and all other medicines out of the reach of children.

POSSIBLE SIDE EFFECTS: As with any other active pharmaceutical product, Alertec may produce side effects, which can vary in their intensity, depending on the patient’s reaction. Should you have any query, do not hesitate to consult your doctor.

DIRECTIONS FOR USE: Use strictly according to your doctor's instructions.

CONDITIONS FOR USE: This pharmaceutical product has been prescribed for you to treat a specific condition. It should not be used for other purposes. It should not be used except under a doctor’s supervision. Another person should not recommend it for use.

EXPIRY DATE: Do not use once the expiry date shown clearly on the box has passed.

ATHLETES: Athletes please note the product contains an active ingredient, which could produce a positive dope test result.