Modafinil belongs to the family of stimulants. It is approved to treat three specific conditions of unusual sleepiness:
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By making some cross-trial comparisons between Provigil and current standard of care Provigil/Nuvigil (which recently went generic), they gave the Jazz drug a ringing endorsement as a best-in-class agent. Importantly, our consultant checks and survey results indicate that Provigil appears to be a needed treatment option and a likely long duration product. The bottom line is that Provigil appears to be the most effective wake-promoting agent ever developed.
This is an important alert for pregnant women and women capable of childbearing who are taking or have recently taken the stimulant drugs modafinil (Provigil) or armodafinil (NUVIGIL). Earlier this month, drug regulators in Canada (Health Canada) and Ireland (Health Products Regulatory Authority) issued notices to health care professionals regarding evidence of an increased risk of congenital birth defects associated with use of modafinil and armodafinil. The notices warned that modafinil should never be used by women who are or may become pregnant. They also emphasized the need for a negative pregnancy test within one week of starting modafinil and for effective contraception during treatment with the drug and for two months after stopping it.
Importantly, the notices also warned that modafinil may reduce the effectiveness of oral contraceptives. Therefore, alternative or additional contraceptive methods are required for women during treatment with modafinil and for two months after stopping the drug. Modafinil and armodafinil are stimulant drugs with nearly identical chemical makeups. Both are approved by the Food and Drug Administration (FDA) for improving wakefulness in adults with excessive sleeping associated with narcolepsy (a neurological condition characterized by an extreme uncontrollable tendency to fall asleep during the day), obstructive sleep apnea (repeated blocking of the upper airway during sleep) and shift work disorder (excessive sleepiness and insomnia in people who work shifts or irregular schedules during the typical sleep period). The Canadian and Irish regulators issued their notices after Teva, the maker of these drugs, informed them of the most recent results from an ongoing U.S. registry study that was created to monitor for birth defects in children of mothers who used either drug during pregnancy. The registry was established at the request of the FDA because of prior evidence of fetal toxicity in animal studies of modafinil and armodafinil.
If you want to buy Provigil online, it can be tough if you don't know where to get it. This stimulant widely used to help people to stay awake — which has been shown to be only moderately effective and to cause life-threatening skin reactions — should not be used, except to treat a rare illness, narcolepsy.
The stimulant, modafinil (Provigil), was approved by the Food and Drug Administration (FDA) in 1998 exclusively for the treatment of narcolepsy, a rare sleep disorder characterized by excessive daytime sleepiness. It belongs to the same drug family as amphetamines and methylphenidate (RITALIN).
The drug, also approved in 2004 to treat obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder (see descriptions of these conditions in the box), has been one of the top 200 drugs prescribed in the U.S. for the past four years, with 2.5 million prescriptions filled in 2007.
Part of its boost into the top 200 drugs, given that it was only approved for the relatively rare medical condition of narcolepsy until 2004, can be attributed to the company's clearly illegal promotion of the drug for a broad array of problems involving sleepiness. The illegal promotion, eventually stopped by the FDA in 2002, included recommending the drug for a broad series of unapproved uses including: When patients complain of fatigue, tiredness, sleepiness, lack of energy, or decreased activity. In addition, the ads claimed that modafinil was superior to other drugs despite the lack of any evidence of this.
The most recent data (2006-2007) from the FDA found that in adults more than 75 percent of the prescriptions were for off-label (unapproved) uses. The most common indication for which the drug was prescribed—even exceeding prescriptions for narcolepsy— was malaise and fatigue, one topic of manufacturer Cephalon's illegal promotion campaign in 2002.
Sleepiness is a legitimate health concern; people who have excess sleepiness are prone to accidents, including falls, and heart problems. However, we urge our readers not to use modafinil unless it has been prescribed to control narcolepsy symptoms.
In 2004 Cephalon attempted to gain approval for the use of modafinil to treat attention deficit hyperactivity disorder (ADHD) but the FDA rejected the request in 2006 because of the concerns about serious skin toxicity in children. Still, almost half of the modafinil prescriptions for children from ages 6 to 17 from March 2004 through March 2007 were for ADHD, according to FDA data. The other half of prescriptions were also off-label because the drug is not approved for any use in children, having also been rejected for use in narcolepsy in children in 2006.
The most recent results from the armodafinil and modafinil registry documented cases of spontaneous abortion and major birth defects, including heart defects in the fetuses of women taking these drugs. Specifically, major congenital birth defects occurred in the fetuses of 17% of the women in this registry compared with 3% of those of pregnant women in the general population. In addition, heart defects occurred in the fetuses of 4% of the pregnant women in this registry, compared with 1% of those of pregnant women in the general population. Notably, other reports have linked these drugs to low fetal growth and poor physical development among babies of women who used the drugs during pregnancy. The warnings in these notices were limited to modafinil because armodafinil is not marketed in Canada or the European Union. However, the restrictions on modafinil also apply to armodafinil. At press time, the FDA has not yet issued similar warnings about these drugs to U.S. health care professionals. The current labeling of modafinil and armodafinil only include a general warning that animal data suggest that these drugs may cause fetal harm. The Canadian and Irish regulators issued their notices after Teva Pharmaceuticals, which now owns Cephalon, informed them of the most recent results from an ongoing U.S. registry study that was created in 2009 to monitor for birth defects in children of mothers who used either drug during pregnancy. The registry was established at the request of the FDA because of prior evidence of fetal toxicity in animal studies of modafinil and armodafinil.
The most recent results from the armodafinil and modafinil registry documented cases of spontaneous abortion and major birth defects, including heart defects, in the fetuses of women taking these drugs. Specifically, major congenital birth defects occurred in the fetuses of 17% of the women in this registry compared with 3% of those of pregnant women in the general population. In addition, heart defects occurred in the fetuses of 4% of the pregnant women in this registry, compared with 1% of those of pregnant women in the general population. Notably, other reports have linked these drugs to low fetal growth and poor physical development among babies of women who used the drugs during pregnancy. The warnings in these notices were limited to modafinil because armodafinil is not marketed in Canada or the European Union. However, the restrictions on modafinil also apply to armodafinil. Disturbingly, at press time, the FDA has not yet issued similar warnings about these drugs to health care professionals and patients in the U.S. The current labeling of modafinil and armodafinil only include a general warning that animal data suggest that these drugs may cause fetal harm.
Name brand Provigil, can be very expensive. It ranges from $40-50 per dose, sometimes even more. Some online vendors, offer further discounts if payment is made with Bitcoin. Additionally, the cost of shipping from places like India is notoriously cheap. In some cases, it's even less expensive to send a package from India to the United States than it is to send a package from one US state to another. Sleepiness is a legitimate health concern; people who have excess sleepiness are prone to accidents, including falls and motor vehicle accidents, and heart problems. However, because of the risks of the drugs, modafinil and armodafinil only be used to control narcolepsy symptoms. In 2004, Cephalon, the manufacturer of modafinil and armodafinil, sought FDA approval for the use of modafinil to treat attention deficit hyperactivity disorder (ADHD), but the FDA rejected the request in 2006 because of concerns about serious skin toxicity in children. Importantly, almost one-half of the modafinil prescriptions for children aged 6 to 17 from March 2004 through March 2007 were for ADHD, according to FDA data. The other half of prescriptions were also for off-label (unapproved) uses because the drug is not approved for any use in children, having also been rejected for treatment of narcolepsy in children in 2006. The most common adverse effects of modafinil and armodafinil seen during placebo-controlled clinical trials included headache, nausea, nervousness or anxiety, diarrhea, dizziness and insomnia. The FDA-approved labeling for both drugs also includes important warnings about several serious adverse effects (see Text Box below for warnings provided in the modafinil labeling).
Serious rash: Rare cases of serious or life-threatening rash requiring hospitalization and discontinuation of treatment have been reported in association with use of modafinil. These skin reactions include Stevens-Johnson syndrome (a painful blistering of the skin, mouth and nose) and toxic epidermal necrolysis (abnormal skin sloughing), among others. There are no factors that are known to predict the risk of occurrence or the severity of these rashes. Nearly all cases of serious rash associated with modafinil occurred within one to five weeks after the start of treatment. Angioedema, anaphylaxis and multi-organ hypersensitivity reactions:Angioedema (a potentially life-threatening allergic reaction that can cause swelling in the skin, lips, mouth and throat, resulting in difficulty breathing) and hypersensitivity (with rash, difficulty swallowing and sudden narrowing of the airways in the lungs) were observed during clinical trials of armodafinil but were not observed in trials of modafinil. However, angioedema has been reported in patients prescribed modafinil since it was approved by the FDA. Hypersensitivity reactions involving multiple organs also have been reported within days of modafinil use, including at least one fatal case.
Buying Provigil online is simple. The first step is to find an online pharmacy to try out. The second step is to decide how many tablets you want to try and determine which type of Provigil you want. The most popular options are Waklert, Modalert, Artvigil, and Modvigil. The third step is to pay for the order. If you want to take advantage of discount with Bitcoin payments, you have to first acquire the Bitcoin. The laws around Provigil can be highly variable depending on the country. As a general rule of thumb, modafinil is considered a prescription-only medication. This makes it impossible to buy it in a store without a doctor’s prescription, but it can still be purchased online from vendors operating out of other regions with more relaxed pharmaceutical medication laws.
Persistent sleepiness: Patients treated with modafinil may not return to a normal level of wakefulness and may need to avoid driving or other potentially dangerous activities. Psychiatric symptoms:Modafinil can cause anxiety, nervousness and insomnia. Mania, delusions, hallucinations, suicidal thoughts and aggression, sometimes resulting in hospitalization, also have been reported in patients using modafinil. Cardiovascular effects:In clinical trials of modafinil, adverse cardiovascular reactions, including chest pain, palpitations, shortness of breath and abnormalities on electrocardiogram occurred in three subjects who had underlying heart disorders. The drug should be used with caution in patients who have cardiovascular disease.
Drug has many amphetamine-like adverse effects
Cephalon states that modafinil's wakefulness-promoting actions are similar to those of amphetamines and methylphenidate not "identical" to these drugs. However, evidence shows modafinil causes a statistically significant increase in hypertension, chest pain, insomnia, anxiety and a decrease in appetite, all of which are found with the amphetamines or amphetamine-like drugs such as methylphenidate.
Drug causes severe skin, psychological reactions
Although the most common side effect of modafinil is a headache, the drug can cause a variety of more serious reactions.
The drug's maker, Cephalon, sent a warning letter to doctors in September 2007 and the FDA issued a warning in October 2007 concerning cases of life-threatening skin reactions such as Stevens- Johnson Syndrome and toxic epidermal necrolysis (TEN). The company's warning letter to doctors states that "Provigil can cause life-threatening skin and other serious hypersensitivity reactions. Although benign rashes also occur with modafinil, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, modafinil should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring."
The company admits, "The reporting rate of TEN and SJS associated with modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate."
The recommended dosage for patients is 200 mg taken orally once a day as a single dose in the morning. The FDA cites six reported cases of severe skin reactions associated with modafinil, including erythema multiforme (EM; a red, bumpy skin rash), Stevens-Johnson syndrome (a rare, severe form of EM), toxic epidermal necrolysis (the detachment of the top layer of skin from lower layers of skin, leading to severe skin sloughing) and drug rash with eosinophilia and systemic symptoms (DRESS; a severe drug reaction that sometimes involves high fever, rash and swelling of internal organs such as the liver, kidneys, lungs and/or heart). Three of these were in adults but three were in patients under 18. Five of the six cases required hospitalization for management.
Patients experienced rashes on either their arms, hands and legs, or the whole body with some experiencing eruptions in the mouth (lips or tongue), eyes or genitals. In addition, some patients developed skin pigment changes, itchiness, ulcers, burning of the skin, mild skin scaling, sloughing and/or fever.
The letter to doctors also warns about another sometimes lifethreatening allergic reaction known as angioedema (swelling of the skin): Angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).
Both the doctor's letter and the FDA warning also notify the public about serious drug-associated psychiatric adverse events, including anxiety, mania, hallucinations and suicidal ideation.
Modafinil lowers tolerance to heat and may also increase blood pressure. In addition, modafinil may lower the levels of white blood cells in children.
Drug only moderately effective
For one of the drug's three approved uses, to treat people on shift work, the key study comparing modafinil to a placebo in such workers found that treated workers still experienced worrisome levels of sleepiness. The study was accompanied by an editorial in the New England Journal of Medicine stating that workers would still be considered greatly impaired regarding vigilance and wakefulness during the nights they would need to remain awake and alert", and that "the current study does not adequately assess the clinical value of this particular drug in shift-work sleep disorder, nor does it justify writing more prescriptions for modafinil.
Modafinil reduces the effectiveness of steroid contraceptives. Additional or alternate methods of birth control are advisable while taking modafinil and for one month after stopping modafinil.
Modafinil has caused fetal abnormalities in animals. Studies have not been done in pregnant women. Safety and effectiveness is not established in children under age 16 and the drug has not been studied in people over age 65.
Very tired people who take a stimulant, such as modafinil, may misinterpret the effect as improved cognitive ability. In pilots kept awake for 37 hours, while their performance with modafinil improved overall, it did not return to normal levels, and did not improve all flight maneuvers.
As discussed earlier, modafinil is widely used in conditions for which it is not approved (off-label uses) based on single reports, or new studies where to buy accutane isotretinoin best place in short-duration, some with conflicting findings.
Comparisons have found 600 mg of caffeine to have similar effects to 600 mg of modafinil in people with sleep deprivation. Athletes should be aware that modafinil is listed as a banned drug by the World Anti- Doping Code.
For obstructive sleep apnea, many people improve sleep with medical devices such as nasal masks for continuous positive airway pressure, or have surgery.
The primary treatment for sleepiness is basic: Get more sleep. Exercise also may temporarily improve alertness. Excess sleepiness can be due to other medical conditions, such as anemia, breathing problems, depression, and low blood sugar, or to drugs, such as central nervous system depressants. Modafinil does not cure any cause of excess sleepiness; it simply addresses the symptoms. Before starting use of this or any drug, be sure to examine and rule out all possible causes of the problem that can be controlled without drug therapy. We will guide you through the process of buying Provigil