The effective elimination half-life of modafinil after multiple doses is about 15 hours. Apparent steady states of total modafinil and R-modafinil are reached after days of dosing.
Food has no effect on overall PROVIGIL bioavailability; however, time to reach peak concentration t max may be delayed by approximately one hour if taken with food.
Urine alkalinization has no effect on the elimination of modafinil. Metabolism occurs through hydrolytic deamidation, S-oxidation, aromatic ring hydroxylation, and glucuronide conjugation.
The largest fraction of the drug in urine was modafinil acid, but at least six other metabolites were present in lower concentrations. Only two metabolites reach appreciable concentrations in plasma, i.
In preclinical models, modafinil acid, modafinil sulfone, 2-[ Provigil Modafinil Ingredients sulfonyl]acetic acid and 4-hydroxy modafinil, were inactive or did not appear to mediate the arousal effects of modafinil. In adults, decreases in trough levels of modafinil have sometimes been observed after multiple weeks of dosing, suggesting auto-induction, but the magnitude of the decreases and the inconsistency Ingrediwnts their occurrence suggest that their clinical significance is minimal.
Significant accumulation of modafinil sulfone has been observed after multiple doses due to its long elimination half-life of 40 hours. Due to potential effects from Provigil Modafinil Ingredients multiple Ingredient medications with which most of the patients were being treated, the apparent difference in modafinil pharmacokinetics may not be attributable solely to the effects of aging. However, the results suggest that the clearance of modafinil may be reduced in the elderly [see Dosage and Administration 2.
Provigil (Modafinil) Oral: Uses, Side Effects, Dosages
The pharmacokinetics and metabolism of modafinil were examined in patients with cirrhosis of the liver 6 men and 3 women. Clinically 8 of 9 patients were icteric and all had ascites. In vitro data also demonstrated that modafinil produced an apparent concentration-related suppression of expression of CYP2C9 activity. Other CYP activities did not appear to be affected by modafinil. The existence of multiple pathways for modafinil metabolism, as well as the fact that a non-CYP-related pathway is the most rapid in metabolizing modafinil, suggest that there is a low probability of substantive effects on the overall pharmacokinetic profile of PROVIGIL due to CYP inhibition by concomitant medications.
There was no evidence of tumorigenesis associated with modafinil administration in these studies. However, the mouse study was inadequate because the high dose was not a maximum tolerated dose MTD. Modafinil was negative in a series of in vitro i. The criteria for narcolepsy include either: 1 recurrent daytime naps or lapses into sleep that occur almost daily for at least three months, plus sudden bilateral loss of postural muscle tone in association with intense emotion cataplexy ; or 2 a complaint of excessive sleepiness or sudden muscle weakness with associated features: sleep paralysis, hypnagogic hallucinations, automatic behaviors, disrupted major sleep episode; and polysomnography demonstrating one of the following: sleep latency less than Provigil Modafinil Ingredients minutes or rapid eye movement REM sleep latency less than 20 minutes.
For entry into these studies, all patients were required to have objectively documented excessive daytime sleepiness, via a Multiple Sleep Latency Test MSLT with two or more sleep onset REM periods and the absence of any other clinically significant active medical or psychiatric disorder.
For each test session, the subject was told to lie quietly and attempt to sleep. Each test session was terminated after 20 minutes if no sleep occurred or 15 minutes after Provigil Modafinil Ingredients onset. For a successful trial, both measures had to show statistically significant improvement.
The MWT measures latency in minutes to sleep onset averaged over 4 test sessions at 2 hour intervals following nocturnal polysomnography. For each test session, the subject was asked to attempt to remain awake without using extraordinary measures. Each test session was terminated after 20 minutes if no sleep occurred or 10 minutes after sleep onset.
Patients were rated by evaluators Provigil Modafinil Ingredients had no access to any data about the patients other than a measure of their baseline severity.
Evaluators were not given any specific guidance about the criteria they were to apply when rating patients. Both studies demonstrated improvement in objective and subjective measures of excessive daytime sleepiness for both the mg and mg doses compared to placebo. The criteria include either: 1 excessive sleepiness or insomnia, plus Provigil Modafinil Ingredients episodes of impaired breathing during sleep, and associated features such as loud snoring, morning headaches and dry mouth upon awakening; or 2 excessive sleepiness or insomnia and polysomnography demonstrating one of the following: more than five obstructive apneas, each greater than 10 seconds in duration, per hour of sleep and one or more of the following: frequent arousals from sleep associated with the apneas, bradytachycardia, and arterial oxygen desaturation in association with the apneas.
CPAP use continued throughout the study. The primary measure of effectiveness was the change from baseline on the ESS at final visit. At week 4, the ESS was reduced by 4. All patients met the criteria for chronic SWD. The criteria include: 1 either, a a primary complaint of excessive sleepiness or insomnia which is temporally associated with a work period usually night work that occurs during the habitual sleep phase, or b polysomnography and the MSLT demonstrate loss of a normal sleep-wake pattern i.
It should be noted that not all patients with a complaint of sleepiness who are also engaged in shift work meet the criteria for the diagnosis of SWD. In the clinical trial, only patients who were symptomatic for at least 3 months were enrolled.
Advise patients to stop taking PROVIGIL and to notify their physician right away if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing, or a related allergic phenomenon.
Advise patients not to alter their previous behavior with regard to potentially dangerous activities e. Inform patients that it may be critical that they continue to take their previously prescribed treatments e.
Advise patients to stop taking PROVIGIL and contact their physician right away if they experience chest pain, rash, depression, anxiety, or signs of psychosis or mania. Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy.
Caution patients regarding the potential increased risk of pregnancy when using steroidal contraceptives including depot or implantable contraceptives with PROVIGIL and for one month after discontinuation of therapy. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
PROVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening. If you have a severe rash with PROVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.
PROVIGIL is a prescription medicine used to improve wakefulness in Provigil Modafinil Ingredients who are very sleepy due to one of the following diagnosed sleep disorders:.
Follow your doctor's advice about good sleep habits and using other treatments. Provigil Modafinil Ingredients your doctor if you Provigil Modafinil Ingredients ever abused or been dependent on alcohol, prescription medicines, or street drugs. Tell your doctor about all of your medical conditions including, if you:. Tell your doctor about all the medicines you takeincluding prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take.
Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. It may harm them and it is against the law. If you would like more information, talk with your doctor. For more information, call Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate. Rx only teva. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between Provigil Modafinil Ingredients drug labels on DailyMed and the pill images provided by RxImagewe no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number Provigil Modafinil Ingredients can be found on the drug's outer packaging. Approval: The following serious adverse reactions are described elsewhere in the labeling: Serious Rash, including Stevens-Johnson Syndrome [see Warnings and Precautions 5. Table 1. For adults with severe liver impairment, the manufacturer recommends reducing the Provigil dose to one-half of that recommended for patients with normal liver function.
There are no specific Provigil dosing adjustments for older adults aged 65 years or older. Yet, since Provigil may be processed more slowly in older individuals, healthcare providers often start at a lower dose and monitor more closely for side effects.
Be sure to tell your provider if you are pregnant or planning to become pregnant. Animal studies suggest that Provigil may cause harm to the baby. In that case, skip the dose and go back to your usual dosing schedule. Taking Provigil too late in the day might cause problems sleeping that night. Do not ever double-up on doses. If you find that you are missing Provigil doses often, consider setting an alarm on your phone, purchasing a pillbox, or asking a loved one or friend to remind you when to take your dose.
Taking more than the maximum recommended dose of Provigil can cause unpleasant side effects. There is no specific antidote to treat a Provigil overdose. Supportive care, including heart monitoring, may be warranted in some cases. Symptoms of a Provigil overdose can include:.
If you think you or someone else may have overdosed on Provigil, call a healthcare provider or the Poison Control Center Your doctor should check your progress at regular visits to make sure that this medicine is working properly. Your blood pressure may need to be checked more often while taking this medicine. Ingredints is important to tell your doctor if you become pregnant.
Provigil (Modafinil) - Oral
Your doctor may want you to join a pregnancy registry for patients Inbredients this medicine. Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the МУЛЬТЯГА Where Can I Buy Provigil Forum жжот)))) red skin lesions; Provigil Modafinil Ingredients acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
This medicine may Provigil Modafinil Ingredients you to have a serious type of allergic reaction called anaphylaxis.
Anaphylaxis can be life-threatening and requires immediate medical attention. PProvigil taking this medicine and call your doctor right away if you have a skin rash; itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine. Provigil Modafinil Ingredients medicine may cause serious allergic reactions affecting multiple body organs e. Stop using this medicine and check with your doctor right away if you have the following symptoms: chest pain or discomfort, fever and chills, dark urine, headache, rash, stomach pain, unusual tiredness, unusual bleeding or bruising, or yellow eyes or skin.
If you think modafinil is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor. If you are using a medicine for birth control such as birth control pills, implants, shots, patches, vaginal rings, or an IUDit may not work properly while you are taking modafinil.
To keep from getting pregnant, use another form of birth control while you are using this medicine and for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies. Modafinil may cause Imgredients people Provigll feel dizzy, drowsy, have trouble thinking or controlling movements, or trouble seeing clearly.
Make sure you know Inhredients you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well. Article source using this medicine and check with your doctor right away if you have the following symptoms while taking the medicine: aggressive behavior, anxiety, depression, hallucinations, mania, thoughts of suicide, or other mental problems.
If you have been taking this medicine for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on modafinil are:. If you have been taking this medicine in large doses or for Inggedients long time, do Provgil stop taking it without first checking with your doctor. Your doctor Mpdafinil want you to gradually reduce the amount you are taking before stopping it completely.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription over-the-counter Intredients medicines and herbal or vitamin supplements. You Provigil Modafinil Ingredients not take Proviggil if Provigil Modafinil Ingredients have a known allergy or sensitivity Peovigil Provigil or any of its Inggedients.
Let your healthcare provider know if you have a history of high blood pressure or mental health, heart, or liver problems. Your healthcare provider may need to monitor these underlying conditions while you are Moeafinil Provigil. Moreover, Provigil is not approved to treat children for any health condition. Studies of children taking Provigil showed serious side effects, including severe skin rashes and psychiatric or nervous system reactions.
Lastly, Provigil is a controlled substance and may be habit forming or lead to dependence. As a result, Provigil should be used cautiously in people who have a history of substance abuse disorder. Peovigil medications may interact with Provigil, including:.
A similar medication called Nuvigil armodafinil is available to use for improving wakefulness in patients with narcolepsy, obstructive sleep apnea, and shift-work disorder. Provigil and Nuvigil share a similar chemical structure, availability, dosing once a daydrug interactions, and side effects. However, blood levels of Nuvigil are higher later in the day compared with Provigil, suggesting that Nuvigil Provigil Modafinil Ingredients be better Provigl improving wakefulness over the course of a day.
Many derivatives and structural analogues of modafinil have been synthesized and studied. Modafinil was originally developed in France by neurophysiologist professor Michel Jouvet and Lafon Laboratories. Modafinil originated with the s invention of a series of benzhydryl sulfinyl compounds, including adrafinilwhich was first offered as an experimental treatment for Ingredienst in France in Inmodafinil was approved by the U.
It was approved for use in the UK in December Modaffinil Modafinil is Ingredientz in the United States by Cephalonwho originally leased the rights from Lafon, but eventually purchased the company in Cephalon began to market armodafinil, the R -enantiomer of modafinil, in the United States in Provigil Modafinil Ingredients After protracted patent litigation and negotiations see belowgeneric versions of Modafimil became available in the US in Patent 4, was issued to Laboratoire L.
Lafon on Provigil Modafinil Ingredients 22,covering the chemical compound modafinil. After receiving an interim term extension of days and pediatric exclusivity of Ingrexients months, it expired on October 22, On October 6,Cephalon filed an additional Modarinil, covering modafinil in the form of particles of defined size.
That patent, U. Patent 5, was issued on April 8, It was reissued in as RE 37, which surrendered the patent. With pediatric exclusivity, this patent expired on April Provigil Modafinil Ingredients, On December 24,anticipating the expiration of exclusive marketing rights, generic drug manufacturers Mylan, Teva, Barr, and Ranbaxy applied to the FDA to market a generic form of modafinil. There is some question of whether a particle size patent is sufficient protection against the manufacture of generics.
Pertinent questions include whether modafinil may be modified or manufactured to avoid the granularities specified in the new Cephalon patent, and whether patenting particle size is invalid because particles of appropriate sizes are likely to be obvious to practitioners skilled in the art.
However, under United States patent law, a patent is entitled to a legal presumption of validity, meaning that in order to invalidate the patent, much more than "pertinent questions" are required.
As of October 31,U. Reissue Patent No. RE 37, has been declared invalid and unenforceable. Lafon ; 3 was obvious at the time the invention was made to a person having ordinary skill in the art under 35 U. Cephalon made an agreement with four major generics manufacturers TevaBarr PharmaceuticalsRanbaxy Laboratoriesand Watson Pharmaceuticals between and to delay sales of generic modafinil in the US until April by these companies in exchange for upfront and royalty payments.
In the United Kingdom, Mylan Inc. In Australia, modafinil is considered to be a Schedule 4 prescription-only medicine or prescription animal remedy.
In mainland Chinamodafinil is strictly controlled like IIngredients stimulants, such as amphetamines and methylphenidate. In Japanmodafinil is Schedule I psychotropic drug. Modafinil is considered a stimulant doping agent and as such is prohibited in sports competitions, in the same category as steroids. In Russia modafinil is Schedule II controlled substance like cocaine Modafiinl morphine.
Possession of few modafinil pills can lead to 3—10 years imprisonment. In Sweden, modafinil is classified as a schedule IV substance and possession is therefore illegal without prescription.
Modafinil is currently [update] classified as a Schedule IV controlled substance under United States federal law; it is illegal to import by anyone other than a DEA -registered importer without a prescription.
However, one may legally bring Ingreduents into the United States in person from a foreign country, provided that he or she has a prescription for it, and the drug is properly declared at the border crossing. Modafinil has been used non-medically as a " smart drug " by students, office workers, soldiers and transhumanists.
The regulation of modafinil as a doping agent has been controversial in the sporting world, with high-profile cases attracting press coverage since several prominent American athletes have tested positive for the substance. Some athletes who were found to have used modafinil protested that the drug was not on the prohibited list at the time of their offenses.
The Agency added modafinil to its list of prohibited substances on August 3,ten days before the start of the Summer Olympics. Provigil Modafinil Ingredients has received some publicity in the past when several Ingredienys such as sprinter Kelli White incyclist David Clinger  and basketball player Diana Taurasi  inand rower Timothy Grant in  were accused of using it as a performance-enhancing doping agent. Taurasi and another player, Monique Coker, tested at the same lab, were later cleared.
Provigil Modafinil Ingredients BALCO scandal brought to light an as-yet unsubstantiated Ingfedients widely published account of Major League Baseball's all-time leading Ingredienfs hitter Imgredients Bonds ' supplemental chemical regimen that included modafinil in addition to anabolic steroids and human growth hormone.
Modafinil has been studied in the treatment of major depressive Ingredinets. Modafinil and armodafinil have been repurposed as adjunctive treatments for acute depression in people with bipolar disorder.
Modafinil has been studied Prvigil reported to be Provigil Modafinil Ingredients in the treatment of attention deficit hyperactivity disorder ADHDwith significantly less abuse potential than conventional psychostimulants like methylphenidate and amphetamines.
Modafinil Modadinil been studied Ingredienfs the Provigil Modafinil Ingredients of stimulant dependence. Modafinil and armodafinil have been studied as a complement to antipsychotic medications in the treatment of schizophrenia. They have been consistently shown to have no effect on positive symptoms or cognitive performance.
A review of clinical Ignredients of possible nootropic Ingrediente in healthy people found: " In contrast, when more complex assessments are used, modafinil appears to consistently Provigil Modafinil Ingredients enhancement of attention, executive functions PProvigil, and learning.
Importantly, we did not observe any preponderances for side effects or mood changes. Modafinil has been used off-label in trials with people with symptoms of post-chemotherapy cognitive impairmentalso known as "chemobrain", but Morafinil review found Provigil Modafinil Ingredients it was no better than placebo. In outpatient settings wherein patients are discharged home after surgery, this sedation, fatigue and occasional dizziness is problematic.
From Wikipedia, the free encyclopedia. Medication which increases wakefulness. IUPAC name. DB Y. Ingredisnts Y. Interactive image. See also: List of drugs used by militaries. PMC Modafinll Because of the relatively low risk of addiction, modafinil can be more easily prescribed in patients without a clear, biochemically defined central hypersomnia syndrome, and is also easier to stop, if needed. It is also a schedule IV compound. J Pharmacol Pharmacotherapy.
American Society of Health-System Pharmacists. Retrieved June 24, Archived from the original PDF on January 7, Retrieved January 20, Clinical Pharmacokinetics. S2CID Drug Metabolism and Disposition. United States Food and Drug Administration. January Retrieved July 18, A systematic review of modafinil: potential clinicaluses and mechanisms of action.
J Clin Psychiatry. Journal of Intredients Psychopharmacology. European Neuropsychopharmacology. Rethinking Cognitive Enhancement. Oxford University Press. ISBN Journal of Psychiatric Research. Journal of Drug Assessment. Pharmaceutical Press. September Socio-anthropologie 43 : 97— ISSN Vice Media.
Archived from the original on November 12, Retrieved March 18, Retrieved April 11, November An American Academy of Sleep Medicine report". Journal of Affective Disorders. Sleep Medicine. Annals of Neurology. Le Monde. December 18, Retrieved May 23, BBC News. Retrieved July 4, The Scotsman. February 27, Archived from the original on Continue reading 1, Retrieved December 31, News — City.
February 16, Archived from the original on March 19, United States Department of the Air Force. Archived from the original PDF on June 12,
What are the ingredients in PROVIGIL?. PROVIGIL tablets contain mg or mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate.