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.

Manufacturer's Insert

MODAFINIL / PROVIGIL

Composition:

Each tablet contains: Active substance: modafinil 100 mg Excipients: monohydrated lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone K90, talc and magnesium stearate.

Pharmaceutical form and content:

Tablets. Box of 30 tablets of 100 mg.

Pharmacotherapeutic category:

Psychostimulant and nootropic agents. The drug acts on the central nervous system to increase the level of vigilance.

Therapeutic indications

Narcolepsy. Modafinil is effective in reducing excessive diurnal drowsiness associated with this condition.

Contraindications

Known hypersensitivity to PROVIGIL or to any component of the preparation. The use of PROVIGIL is contraindicated during pregnancy and lactation (see. Special warnings).

Precautions for use:

Patients suffering from anxiety should receive treatment with PROVIGIL at specialist units only. Patients should be advised to inform their doctor in case of potential pregnancy or if they are planning to become pregnant during therapy. In the light of these circumstances, treatment with modafinil should be suspended. In the hypertensive patient, blood pressure and heart rate should be monitored. PROVIGIL tablets should not be administered to patients with a history of left ventricular hypertrophy or with ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestation of prolapse of the mitral valve associated with the use of C.N.S. stimulants.

Interactions:

Oral contraceptives: because of the enzyme induction of PROVIGIL, the efficacy of oral contraceptives may be compromised. In case of the use of oral contraceptives, a product containing 50 mg or more of ethinyl oestradiol should be taken. Adequate contraception requires continuation of the oral contraceptive for two cycles after stopping PROVIGIL.

Tricyclic antidepressants:in a single dose pharmacokinetic interaction study of PROVIGIL (200 mg) and clomipramine (50 mg), no clinically important alterations were noted in the pharmacokinetic profile of PROVIGIL or clomipramine. Given the limited experience or the concomitant administration of PROVIGIL with this class of drugs, patients receiving these drugs should be carefully monitored.

Anti-convulsant therapy: no formal interaction studies of PROVIGIL have been conducted with these drugs and the concomitant administration of these drugs should therefore be undertaken with caution.

Special warnings:

Whilst studies carried out with modafinil and other psychoactive agents have shown a low dependence potential, the possibility of dependence following prolonged use cannot be entirely ruled out. Since the safety and efficacy in controlled studies in children have not been established, the use of PROVIGIL is not recommended in children.

Pregnancy and lactation: PROVIGIL is contraindicated for use in pregnancy or during lactation.

Effect on the ability to drive and operate machinery:No information is available concerning the effects of PROVIGIL on the ability to drive or operate machinery.

Dose, method and time of administration:

Adults:The recommended daily dose is 200-400 mg. PROVIGIL may be taken as two divided doses in the morning and at noon, or as a single dose in the morning according to physician assessment of the patient and the patient's response.

Elderly:There is limited data available on the use of PROVIGIL in elderly patients. Since clearance tends to be reduced with advancing age, it is recommended that patients over 65 years of age should commence therapy at 100 mg daily. In the absence of renal or hepatic impairment, the dose can be subsequently increased to 400 mg/day, depending on response.

Renal and hepatic impairment:The dose in patients with hepatic or renal impairment should be halved (100-200 mg/day).

Overdose:

The main symptom following massive ingestion is insomnia. Treatment: induced vomiting and gastric lavage should be considered. Hospitalisation and surveillance of psychomotor status, cardiovascular monitoring or surveillance, until the patient's symptoms have resolved.

What to do if you forget to take one or more doses of PROVIGIL:

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

Undesirable effects:

Episodes of a feeling of nervousness, excitation, aggressive tendencies, insomnia, anorexia, headache, CNS stimulation, abdominal pain, dry mouth, palpitations, tachycardia and tremor. Gastrointestinal disorders (nausea, gastric discomfort) have also been reported, usually regressing when tablets are taken during meals. There have also been reports of pruritic skin rashes and, very rarely, cases of buccofacial dyskinesia. Compliance with the instructions in this leaflet will reduce the onset of undesirable effects. Inform your doctor or pharmacist if you experience any undesirable effects not described above.

EXPIRY AND STORAGE:

See the expiry date indicated on the pack; this date refers to the product in its unopened and correctly stored pack.

Store the product in a safe and dry place below 25°C; protect from heat sources and sunlight.

IMPORTANT: Do not use the medicine after the expiry date printed on the pack.

KEEP OUT OF THE REACH OF CHILDREN