Provigil (Modafinil) - Summary

PROVIGIL SUMMARY

PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide.

PROVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.

In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.

In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

See all Provigil indications & dosage >>

PROVIGIL NEWS HIGHLIGHTS

Media Articles Related to Provigil (Modafinil)

Is Provigil Addictive?
Source: MedicineNet Narcolepsy Specialty [2009.03.18]
Title: Is Provigil Addictive?
Category: Health News
Created: 3/18/2009
Last Editorial Review: 3/18/2009

Stay-Awake Drug Provigil: New Warnings
Source: MedicineNet modafinil Specialty [2007.10.25]
Title: Stay-Awake Drug Provigil: New Warnings
Category: Health News
Created: 10/25/2007
Last Editorial Review: 10/25/2007

APSS: Armodafinil Normalizes Alertness for Shift Workers (CME/CE)
Source: MedPage Today Neurology [2009.06.18]
SEATTLE (MedPage Today) -- Armodafinil (Nuvigil) brings wake-time sleepiness levels back to normal for symptomatic shift workers after just one night of treatment, researchers found.

Cephalon Submits NUVIGIL Supplemental New Drug Application For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder
Source: Pharma Industry / Biotech Industry News From Medical News Today [2009.07.01]
Cephalon, Inc. (Nasdaq: CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

What Is Narcolepsy? What Causes Narcolepsy?
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.24]
Narcolepsy - from the French narcolepsie, which was derived from the Greek narke meaning numbness and lepsis meaning attack or seizure - is a chronic sleep disorder where the brain is unable to regulate the body's sleep-wake cycles. People with narcolepsy may feel an overwhelming urge to sleep at various points in the day, and they will often fall asleep spontaneously for a few seconds to a few minutes.

more news >>

Published Studies Related to Provigil (Modafinil)

An Exploration of the Effect of Modafinil on Olanzapine Associated Weight Gain in Normal Human Subjects. [2008.12.20]
BACKGROUND: Weight gain has been associated with many second generation antipsychotics (SGAs). A variety of theories have been put forward as to the etiology of SGA-associated weight gain. Modafinil [generic for Provigil] possesses pharmacologic effects that could influence the weight gain associated with SGAs. The objective of this trial was to determine the effect of modafinil on olanzapine-associated weight gain... CONCLUSIONS: The results of this trial should not be extrapolated to clinical practice at this time. These data do serve to support further evaluation in a patient population to determine if the weight modifying effect of modafinil can be demonstrated over a longer period of time.

Modafinil shifts human locus coeruleus to low-tonic, high-phasic activity during functional MRI. [2008.12.12]
Models of cognitive control posit a key modulatory role for the pontine locus coeruleus-norepinephrine (LC-NE) system. In nonhuman primates, phasic LC-NE activity confers adaptive adjustments in cortical gain in task-relevant brain networks, and in performance, on a trial-by-trial basis...

Modafinil as an adjunctive treatment of sedation, negative symptoms, and cognition in schizophrenia: A critical review. [2008.11.18]
CONCLUSIONS: While the available data suggest that modafinil [generic for Provigil] is generally well tolerated and may have some efficacy in the treatment of antipsychotic-induced sedation and cognitive domains, the small sample sizes, contradictory results, and methodological differences between trials, especially with respect to cognitive testing, make it difficult to draw firm conclusions about the overall effectiveness of modafinil as an adjunct in the treatment of schizophrenia. Well-powered, prospective, randomized placebo-controlled trials using the MATRICS battery concomitantly with functional outcome measures are necessary to elucidate modafinil's efficacy and effectiveness as an adjunctive treatment for sedation, negative symptoms, and cognitive deficits in schizophrenia. Hence, before prescribing modafinil to a schizophrenia patient, the possible risks and benefits of each particular case should be evaluated. (c) Copyright 2008 Physicians Postgraduate Press, Inc.

A placebo-controlled trial of modafinil for nicotine dependence. [2008.11.01]
BACKGROUND: Nicotine deprivation symptoms, including fatigue and attentional deficits, predict relapse following smoking cessation. Modafinil (Provigil), a wakefulness medication shown to have efficacy for the treatment of cocaine addiction, was tested as a novel therapy for nicotine dependence in a double-blind placebo-controlled trial... CONCLUSIONS: These data do not support the use of modafinil for the treatment of nicotine dependence and, as a consequence, this trial was discontinued. Cigarette smoking should be considered when modafinil is prescribed, particularly among those with psychiatric conditions that have high comorbidity with nicotine dependence.

Effects of modafinil and sleep loss on physiological parameters. [2008.11]
OBJECTIVE: The purpose of this study was to determine the effects of modafinil [generic for Provigil] administration on physical performance, thermoregulation, and total energy expenditure (TEE) during continued wakefulness in Air Force operators... CONCLUSION: modafinil did not improve physical performance. Despite elevating oral temperature, water turnover and TEE were similar between treatments. These findings suggest it is unnecessary for operators taking modafinil to carry additional fluids and/or food.

more studies >>

Clinical Trials Related to Provigil (Modafinil)

A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia [Completed]
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy [Completed]
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

Modafinil Treatment for Cocaine-Dependent Individuals [Active, not recruiting]

Fasting Study of Modafinil Tablets 200 mg and Provigil® Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg) dose administration under fasting conditions.

Food Study of Modafinil Tablets 200 mg to Provigil® Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg) dose administration under fed conditions.

more trials >>

PROVIGIL PATIENT REVIEWS / RATINGS / COMMENTS

Provigil review by medical professional caring for 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Excessive fatigue
Dosage & duration:		200 mg taken daily for the period of started 2 months ago, still on it
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		As a medical professional (newly graduated medical student now in first year of residency), I am able to feel more alert and focused during the day even after having been up all night. As free time is scarce in residency, I am now able to study when I would otherwise be too exhausted to do anything.
Side effects:		I really did not have any side effects. It has been reported that headache is common, however I did not experience that at all. I did not have any problems with my sleep schedule either.
Comments:		Recommended dose is 200mg once a day, can also be taken again in the afternoon if needed.

Provigil review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Multiple Sclerosis
Dosage & duration:		400-600 mg. per day taken once a day for the period of 7 years
Other conditions:		Diabetes
Other drugs taken:		, Glucophage, Gemfibrozil, Bacflofen,Effexor
		Reported Results
Benefits:		Provigil energizes me which improves my ability to function. Without it, the fatigue I experience due to MS overwhelms me and renders me pretty much useless.
Side effects:		The only side effect is increased wakefulness at night when I'd like to go to sleep.
Comments:		The neurologist who first diagnosed the MS prescribed Provigil in 2001. At first I took only 100 milligrams per day, but have gradually increased the dose in order to get the same effect I got initially. I've asked my doctors several times if the drug is addictive, and they say it is not supposed to be.

Provigil review by 55 year old male patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Daytime sleepiness
Dosage & duration:		100mg taken 3 per day for the period of 7 weeks
Other conditions:		Depression
Other drugs taken:		Cymbalta
		Reported Results
Benefits:		Virtually nil. PLEASE< PLEASE read on....
Side effects:		If you take a look at the side effects the FDA requires Provigil manufacturer Cephalon to list, you will find the usual stomach aches, headaches etc.. Such side effects are so common that virtually every new prescription medication ends up listing them, which is why most of us don't bother reading the side effect profile for meds. However, failing to look at the side effects for Provigil could end up costing you your life. Provigil of course does list the usual side effects, yes, but ther is one side effect listed that is rarely included as a medication side effect. Further, even if you should happen to actually read the list of Provigil's side you are not likely to know what it means. The side effect is called "vasodilatation", and the manufacturer reported to the FDA that it occurred to 1 out of every 50 test subjects while it happened to 0 out of every 50 who took the placebo. What is "vasodilatation"? Vasodilatation, nearly always referred to as the more recognizable "vasodilation", refers to the general relaxation of blood vessels, a phenomenon that usually ends up causing a small drop in blood pressure but sometimes causes a significant blood pressure drop, when it is then called hypotension. And, if you'll read on, you'll see why for me, and potentially for 1 out of every 50 users of Provigil, it very nearly killed me. After 7 weeks on Provigil, with the last week having been increased from 200mg to 300mg per day, I awoke one morning in a highly delusional state, speaking of non-existent farm animals wandering around the kitchen table where my wife and I were seated. After apparently collapsing in my bedroom, I was taken to ER, which quickly determined that I was critically hypotensive (low blood pressure of 72/35). I quickly lapsed into cardiogenic shock, a condition where the heart all but stops pumping blood and one of the deadliest of all medical crises. Even among those who are still alive upon arrival at an ER, 70% to 80% die within hours or a few days. Those who survive likely do so, as I did, with kidneys in acute failure and brain damage similar to what is sustained by near-drowning victims who have been resuscitated by a lengthy CPR session.
Comments:		My ER doctor immediately paged the cardiologist on call. Arriving quickly, he assessed my condition and determined that my only chance of survival was a transport to a regional heart center 35 miles away. As he awaited the ambulance, he took me to my local hospital's heart catheterization lab, not to put a stent in, but to push a tiny balloon through my femoral artery to a destination next to my aorta, after which a tiny battery powered air pump was used to inflate the balloon and keep it inflated. The balloon (called an intra-aortic balloon pump) works by temporarily filling the empty space around the heart, then applying continuous gentle pressure to my aorta in an effort to keep my blood pressure from additional falling past the small amount that would otherwise kill me. Arriving at the heart center I was unconscious and would lapse into a coma for 9 days, kept alive by mechanical ventilation through a tube inserted through my throat to my lungs ("I'm in", the TV doctors always say when the get the insertion right).