In some studies, modafinil was also partially discriminated as stimulant-like. Patients should be observed for signs of misuse or Provigkl e.
The abuse potential Provigil Description modafinil, and mg was assessed relative to methylphenidate 45 and 90 mg in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced Prlvigil and euphoric effects and feelings consistent with other scheduled CNS stimulants methylphenidate. In one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use.
There were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients. In addition, several intentional acute overdoses occurred; the two largest being mg and mg taken by two subjects participating Desscription foreign depression studies. None of these study Provigil Description experienced any unexpected or life-threatening effects.
Adverse reactions that were reported at these doses included excitation or agitation, insomnia, and slight or moderate Provigil Description in hemodynamic parameters. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep Deacription, nausea, diarrhea, and decreased prothrombin time.
From postmarketing experience, there have been reports of fatal overdoses involving modafinil alone or in combination with other drugs. Symptoms most Descriptjon accompanying PROVIGIL overdose, alone or in combination with other drugs have included insomnia; central nervous system symptoms such as restlessness, disorientation, article source, agitation, anxiety, excitation, and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
The child remained stable. The symptoms associated with overdose in children were similar to those observed in adults. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring. Modafinil is a racemic compound. Provigil Description is a white to off-white, crystalline powder that is practically insoluble in water Provigil Description cyclohexane.
It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain mg or mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, Descirption pregelatinized starch. The mechanism s through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of the sympathomimetic amines.
Modafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, modafinil binds to the dopamine transporter and inhibits dopamine reuptake. This activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals.
In genetically engineered mice lacking the dopamine transporter DATmodafinil lacked wake-promoting activity, suggesting that this activity was DAT-dependent. However, the wake-promoting effects of modafinil, unlike those of amphetamine, were not antagonized by the dopamine receptor antagonist haloperidol in rats.
In addition, alpha-methyl-p-tyrosine, a dopamine synthesis inhibitor, blocks the action of amphetamine, but does not block locomotor activity induced by modafinil.
In the cat, equal wakefulness-promoting doses of methylphenidate and amphetamine increased neuronal activation throughout the Porvigil. Modafinil at an equivalent wakefulness-promoting dose selectively and prominently increased DDescription activation in more discrete regions of the brain. The relationship of this finding in cats to the effects of modafinil in humans is unknown. In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and Porvigil effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans.
Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine; modafinil was also partially discriminated as stimulant-like. The optical enantiomers of modafinil have similar pharmacological actions in animals. Two major metabolites of modafinil, modafinil acid and modafinil sulfone, do not appear to contribute to the CNS-activating properties of modafinil.
Modafinil is a racemic compound, whose enantiomers have Provigl pharmacokinetics e. The enantiomers do not interconvert. At steady Provigil Description, total exposure to R-modafinil is approximately three times that Provigil Description S-modafinil.
The effective Desrciption half-life of modafinil after multiple doses is about 15 hours. Apparent steady states of total modafinil and R-modafinil are Provigil Description after days of dosing. Food has no Descritpion 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 Provigil Description were present in lower concentrations.
Only two metabolites reach appreciable concentrations in plasma, i.
Provigil - Side Effects, Uses, Dosage, Overdose, Pregnancy, Alcohol | RxWiki
In preclinical models, modafinil acid, modafinil sulfone, 2-[ diphenylmethyl 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 of 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 the multiple concomitant 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 Provigil Description the elderly [see Dosage and Administration 2. The pharmacokinetics Provigil Description metabolism of modafinil were examined in patients with cirrhosis of the liver 6 men and 3 women. Provjgil 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 Provigil Description multiple pathways for modafinil metabolism, as well as the fact that a non-CYP-related pathway is the most rapid in metabolizing Descrption, suggest that there is a low probability of substantive effects on the overall pharmacokinetic profile of PROVIGIL due to CYP Desccription 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 Descriprion 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 10 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 Descriptlon 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 sleep 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 Descripfion 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 Provigil Description or 10 minutes after sleep onset. Patients were rated by evaluators who 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 Descritpion 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 frequent episodes of impaired breathing during sleep, and associated features such as loud snoring, morning headaches and dry mouth upon Provigil Description 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 Descrjption 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. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Provigil is excreted in human breast milk or if it will harm your nursing baby. Take Provigil exactly as prescribed by your doctor.
Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.
The dosage of Provigil must be individualized. For patients with narcolepsy and obstructive sleep apnea OSAProvigil should be taken as a single dose in the morning. For patients with shift work disorder SWDProvigil should be taken approximately 1 hour prior to the start of their work Provigil Description.
If you take more than your prescribed dose Provigil Description if you take an overdose of Provigil, call your doctor or poison control center right away. Symptoms of an overdose of Provigil may include:. Provigil treats certain sleep disorders including narcolepsy and shift work sleep disorder.
Avoid drinking alcohol while taking this medication. Provigil Overview Updated: December 18, Proovigil medication comes in tablet form and is usually Prvigil once a day in the morning, for people with narcolepsy and obstructive sleep apnea. People with shift work disorder usually take Provigil about 1 hour before their work shift.
How was your experience with Provigil? First, a little about yourself Male Female.
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What tips would you provide a friend before taking Provigil? Choose one. Back Next. How well did Provigil work for you? Did you experience many side effects while taking this drug? How likely would you be to recommend Provigil to a friend? Back Submit.
Provigil Cautionary Labels Back to Top. Uses of Provigil Back to Top. Provigil is a prescription Provigil Description used to improve wakefulness in adults who are Provigil Description sleepy due to one of the following diagnosed sleep disorders: narcolepsy obstructive sleep apnea OSA.
Provigil is used with other medical treatments for this sleep disorder. Manufacturer Back to Top. Generic Back to Top. Modafinil For more information on this medication choose from the list of selections below. Advertising revenue supports our not-for-profit mission. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press.
See more conditions. Drugs and Supplements Modafinil Oral Route.
Modafinil reduces extreme sleepiness due to narcolepsy and other sleep disorders, such as periods of stopped breathing during sleep (obstructive sleep. Modafinil, sold under the brand name Provigil among others, is a medication to treat sleepiness due to narcolepsy, shift work sleep disorder.