Generic Provigil (Modafinil)

Modafinil is an eugeroic drug generally prescribed to treat narcolepsy. Eugeroic simply means ‘good arousal’. This unique class of drug contains only two at present, Adrafinil and Modafinil. Modafinil is marketed as a "wakefulness promoting agent." The most popular brand is Provigil, others include Alertec, Vigicer, and Modalert.

Although Modafinil 200mg is FDA-approved only for narcolepsy, many physicians are prescribing it for patients who do not suffer from this condition. In fact, it is estimated that 90% of patients buy provigil for "off-label" use.

Modafinil is being prescribed for many “lifestyle” uses, including:

Age-related memory decline
Depression Fatigue caused by high-pressure jobs requiring long hours
Fatigue caused by chemotherapy treatment for cancer patients
Fatigue experienced by persons suffering from diseases such as multiple sclerosis
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
Attention deficit disorder
Memory problems associated with Alzheimer’s disease
Post-anesthesia grogginess
Sleepiness caused by other prescription medications
Treatment for cocaine addiction

Currently, many clinical trials are taking place to assess the effectiveness in using modafinil to treat other conditions than EDS (Excessive Daytime Sleepiness) associated with narcolepsy, OSAHS (Obstructive Sleep Apnea/hypopnoea syndrome and SWSD (Shift Work Sleep Disorder).

What is Modafinil?
Modafinil is an mind and mood enhancing stimulant that is not addictive, has no side effects and does not affect sleep. You can buy modafinil with many different commercial trade names such as Modalert, Provigil (USA), Vigicer (Canada), Sparlon, Alertec, Modalert.

What does it do?
Modafinil is a memory-improving and mood-brightening psychostimulant. It enhances wakefulness and vigilance, but its pharmacological profile is notably different from the amphetamines, methylphenidate (Ritalin) or cocaine.

What makes Modafinil unique?
The basis of its uniqueness lies in its ability to stimulate only when stimulation is required. As a result the ‘highs and lows’ associated with other stimulants such as amphetamine are absent. Modafinil does not bring about the anxiety, agitation and insomnia associated with these more familiar stimulants. Normal sleep patterns are not affected, nor is Modafinil addictive or accompanied by the number of side effects present with currently prescribed stimulants.

How does it work?
Modafinil induces wakefulness in part by its action in the anterior hypothalamus. It appears to only stimulate alpha-1 brain receptors that are responsible for the uptake of nor-adrenaline. Its dopamine-releasing action is weak and dose-dependent, making the chances of a euphoric response, dose-escalation or becoming tolerant to the drug very unlikely.

What is Modafinil used for?
Modafinil is proving clinically useful in the treatment of narcolepsy, a neurological disorder marked by uncontrollable attacks of daytime sleepiness. Experimentally, Modafinil is also used in the treatment of Alzheimer's disease, depression, attention-deficit disorder, myotonic dystrophy, multiple sclerosis-induced fatigue, post-anaesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia, jet-lag and everyday cat-napping.

What is the correct Modafinil dose?
Take exactly as prescribed by your physician. General guidelines indicate one 100mg tablet for a period of up-to 8-hours stimulation, once or twice daily.

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.

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

Avoid use in the evening.

What are the 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.

What drugs does it interact with?
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.

Are there any special warnings with this medication?
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. No information is available concerning the effects of PROVIGIL on the ability to drive or operate machinery. 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.

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

In the event of 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 about missed dose?
If you forget to take a dose of PROVIGIL, take the next dose at the usual time. Never take a double dose.

What about provigil side 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.