Addictive Qualities of Modafinil Not Discussed by FDA Advisory

[Guest guest]

Addictive Qualities of Modafinil Not Discussed by FDA Advisory

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org/cms/

FYI

The focus of a recent FDA's Psychopharmacology

Advisory Committee meeting,

was the drug, modafinil (as Sparlon), for ADHD

and the risk of

-'s, a rare but potentially fatal,

skin condition.

The Committee and the FDA recommended that the

Celaphon provide additional

data about that risk. However, there is concern

about evidence-acknowledged

in the Physician's Desk Reference (i.e., drug

label) that modafinil is

likely to be as 'reinforcing' (i.e., addictive)

as COCAINE.

What in Heaven's name are we doing by encouraging

the prescribing of highly

addictive drugs to our children?

What is the public health justification that

prompts the FDA to support the

prescribing of powerful psychotropic drugs for

children dubiously diagnosed

with ADHD?

In the case of psychostimulants-which FDA's

Pediatric Advisory Committee

examined-the drugs were found to act like

Cocaine: inducing psychosis,

hallucinations, and violence in children.

Like Cocaine, the prescribed drugs for ADHD are

addictive.

The manufacturer's label states:

" PROVIGIL produces psychoactive and euphoric

effects, alterations in mood,

perception, thinking and feelings typical of

other CNS

stimulants....Modafinil is reinforcing, as

evidenced by its

self-administration in monkeys previously trained

to self-administer

cocaine....Adverse experiences that were reported

at these [high] doses

included excitation or agitation, insomnia, and

slight or moderate

elevations in hemodynamic parameters. Other

observed high-dose effects in

clinical studies have included anxiety,

irritability, aggressiveness,

confusion, nervousness, tremor, palpitations,

sleep disturbances, nausea,

diarrhea and decreased prothrombin time. " See:

http://www.biopsychiatry.com/modafinil/modafinil-provigil.pdf

To overcome the documented adverse event profile

disclosed in the label,

drug manufacturers hire academic-affiliated

" experts " to write reports (or

merely sign off on articles) that downplay the

product's adverse effects--or

even deny they exist.

In the case of modafinil, its addictive and

euphoric effect is denied in a

recent report published in the American J of

Psychiatry (August 2005) by Dr.

O'Brien, of the University of

Pennsylvania.

Below, AHRP board member, Dr. Stefan Kruseuzki,

challenges Dr. O'Brien and

the American J of Psychiatry for misrepresenting

the addictive qualities of

modafinil.

Of note, Dr. O'Brien has served as a paid

consultant to Cephalon, the

drug's manufacturer.

See financial disclosure: A Dackis,

M Kampman1, G Lynch1,

Helen M Pettinati1 and P O'Brien

A Double-Blind, Placebo-Controlled Trial of

Modafinil for Cocaine

Dependence, Neuropsychopharmacology (2005) 30,

205-211.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

The American Journal of Psychiatry

March, 2006

Euphorigenic and Abusive Properties of Modafinil

STEFAN P. KRUSZEWSKI, M.D.

burg, Pa.

To the Editor:

In the August issue of the Journal, P.

O'Brien, M.D., Ph.D. (1)

<http://ajp.psychiatryonline.org/cgi/content/full/163/3/549>

stated the

following about modafinil, a drug that he

reported may decrease cocaine use

in some cocaine users: " The medication has not

been reported to produce

euphoria, and there has been no indication of

excessive use or abuse in

clinical trials " (p. 1428). As the scientific

basis for his comment, the

author referenced his own group's work (2) .

The author's statement does not appear to be

supported by his referenced

work, nor is it supported by information widely

available in the 2004

edition of the Physicians' Desk Reference (PDR).

The referenced article, for

example, may demonstrate that modafinil can, in

some cases, blunt cocaine

euphoria. However, it does not say anything about

modafinil's intrinsic

ability to produce euphoria (or not). Separately,

the 2004 PDR raises

specific concerns about modafinil, saying that it

can produce " psychoactive

and euphoric effects, alterations in mood,

perception, thinking and feelings

typical of other CNS stimulants. " The PDR also

states that " modafinil is

reinforcing, as evidenced by its

self-administration in monkeys previously

trained to self-administer cocaine. "

The author's comment about the lack of

euphorigenic effects of modafinil is

also contradicted by the U.S. Food and Drug

Administration (FDA) in its

warning letter of Jan. 14, 2002, sent to M.

Kirsch, the senior director

of regulatory affairs of Cephalon, Inc., the

makers of modafinil. It is

available online (3) . That letter specifically

reiterates the package

insert for modafinil, addressing its abuse

potential and euphorigenic

effects.

That the euphorigenic side effects or abuse

potential may be minimized has

current treatment implications because modafinil

is increasingly promoted

for fatigue and excessive sleepiness unrelated to

narcolepsy as well as for

cocaine abuse. However, the implications loom

even larger because the makers

of modafinil have submitted the " reformulated "

drug to the FDA under a new

name-Attenace-for the treatment of attention

deficit hyperactivity disorder

(4)

References

1. O'Brien CP: Anticraving medications for

relapse prevention:

a possible new class of psychoactive medications.

Am J Psychiatry 2005;

162:1423-1431[Abstract/Free Full Text]

<http://ajp.psychiatryonline.org/cgi/ijlink?

linkType=ABST & journalCode=ajp & re

sid=162/8/1423>

2. Dackis CA, Kampman KM, Lynch KG, Pettinati

HM, O'Brien CP: A

double-blind, placebo-controlled trial of

modafinil for cocaine dependence.

Neuropsychopharmacology 2005;

30:205-211[CrossRef]

<http://ajp.psychiatryonline.org/cgi/external_ref?

access_num=10.1038/sj.npp.

1300600 & link_type=DOI>

3. JR: FDA Warning Letter to M

Kirsch, Senior

Director, Regulatory Affairs, Cephalon Inc re:

NDA #20-717, Provigil

(modafinil) Tablets, MACMIS ID #10183, Jan 14,

2002.

" http://www.pharmcast.com/WarningLetters/Yr2002/Jan2002/Cephalon0102.h

tm "

4. Cephalon Files Application for Marketing

Approval of New

Modafinil Formulation for the Treatment of

Children and Adolescents With

Attention-Deficit/Hyperactivity Disorder. West

Chester, Pa, Cephalon, Dec

21, 2004.

" http://www.drugs.com/NDA/attenace_041221.html "

FAIR USE NOTICE: This may contain copyrighted (C

) material the use of which

has not always been specifically authorized by

the copyright owner. Such

material is made available for educational

purposes, to advance

understanding of human rights, democracy,

scientific, moral, ethical, and

social justice issues, etc. It is believed that

this constitutes a 'fair

use' of any such copyrighted material as provided

for in Title 17 U.S.C.

section 107 of the US Copyright Law. This

material is distributed without

profit.

[Guest guest]

Addictive Qualities of Modafinil Not Discussed by FDA Advisory

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org/cms/

FYI

The focus of a recent FDA's Psychopharmacology

Advisory Committee meeting,

was the drug, modafinil (as Sparlon), for ADHD

and the risk of

-'s, a rare but potentially fatal,

skin condition.

The Committee and the FDA recommended that the

Celaphon provide additional

data about that risk. However, there is concern

about evidence-acknowledged

in the Physician's Desk Reference (i.e., drug

label) that modafinil is

likely to be as 'reinforcing' (i.e., addictive)

as COCAINE.

What in Heaven's name are we doing by encouraging

the prescribing of highly

addictive drugs to our children?

What is the public health justification that

prompts the FDA to support the

prescribing of powerful psychotropic drugs for

children dubiously diagnosed

with ADHD?

In the case of psychostimulants-which FDA's

Pediatric Advisory Committee

examined-the drugs were found to act like

Cocaine: inducing psychosis,

hallucinations, and violence in children.

Like Cocaine, the prescribed drugs for ADHD are

addictive.

The manufacturer's label states:

" PROVIGIL produces psychoactive and euphoric

effects, alterations in mood,

perception, thinking and feelings typical of

other CNS

stimulants....Modafinil is reinforcing, as

evidenced by its

self-administration in monkeys previously trained

to self-administer

cocaine....Adverse experiences that were reported

at these [high] doses

included excitation or agitation, insomnia, and

slight or moderate

elevations in hemodynamic parameters. Other

observed high-dose effects in

clinical studies have included anxiety,

irritability, aggressiveness,

confusion, nervousness, tremor, palpitations,

sleep disturbances, nausea,

diarrhea and decreased prothrombin time. " See:

http://www.biopsychiatry.com/modafinil/modafinil-provigil.pdf

To overcome the documented adverse event profile

disclosed in the label,

drug manufacturers hire academic-affiliated

" experts " to write reports (or

merely sign off on articles) that downplay the

product's adverse effects--or

even deny they exist.

In the case of modafinil, its addictive and

euphoric effect is denied in a

recent report published in the American J of

Psychiatry (August 2005) by Dr.

O'Brien, of the University of

Pennsylvania.

Below, AHRP board member, Dr. Stefan Kruseuzki,

challenges Dr. O'Brien and

the American J of Psychiatry for misrepresenting

the addictive qualities of

modafinil.

Of note, Dr. O'Brien has served as a paid

consultant to Cephalon, the

drug's manufacturer.

See financial disclosure: A Dackis,

M Kampman1, G Lynch1,

Helen M Pettinati1 and P O'Brien

A Double-Blind, Placebo-Controlled Trial of

Modafinil for Cocaine

Dependence, Neuropsychopharmacology (2005) 30,

205-211.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

The American Journal of Psychiatry

March, 2006

Euphorigenic and Abusive Properties of Modafinil

STEFAN P. KRUSZEWSKI, M.D.

burg, Pa.

To the Editor:

In the August issue of the Journal, P.

O'Brien, M.D., Ph.D. (1)

<http://ajp.psychiatryonline.org/cgi/content/full/163/3/549>

stated the

following about modafinil, a drug that he

reported may decrease cocaine use

in some cocaine users: " The medication has not

been reported to produce

euphoria, and there has been no indication of

excessive use or abuse in

clinical trials " (p. 1428). As the scientific

basis for his comment, the

author referenced his own group's work (2) .

The author's statement does not appear to be

supported by his referenced

work, nor is it supported by information widely

available in the 2004

edition of the Physicians' Desk Reference (PDR).

The referenced article, for

example, may demonstrate that modafinil can, in

some cases, blunt cocaine

euphoria. However, it does not say anything about

modafinil's intrinsic

ability to produce euphoria (or not). Separately,

the 2004 PDR raises

specific concerns about modafinil, saying that it

can produce " psychoactive

and euphoric effects, alterations in mood,

perception, thinking and feelings

typical of other CNS stimulants. " The PDR also

states that " modafinil is

reinforcing, as evidenced by its

self-administration in monkeys previously

trained to self-administer cocaine. "

The author's comment about the lack of

euphorigenic effects of modafinil is

also contradicted by the U.S. Food and Drug

Administration (FDA) in its

warning letter of Jan. 14, 2002, sent to M.

Kirsch, the senior director

of regulatory affairs of Cephalon, Inc., the

makers of modafinil. It is

available online (3) . That letter specifically

reiterates the package

insert for modafinil, addressing its abuse

potential and euphorigenic

effects.

That the euphorigenic side effects or abuse

potential may be minimized has

current treatment implications because modafinil

is increasingly promoted

for fatigue and excessive sleepiness unrelated to

narcolepsy as well as for

cocaine abuse. However, the implications loom

even larger because the makers

of modafinil have submitted the " reformulated "

drug to the FDA under a new

name-Attenace-for the treatment of attention

deficit hyperactivity disorder

(4)

References

1. O'Brien CP: Anticraving medications for

relapse prevention:

a possible new class of psychoactive medications.

Am J Psychiatry 2005;

162:1423-1431[Abstract/Free Full Text]

<http://ajp.psychiatryonline.org/cgi/ijlink?

linkType=ABST & journalCode=ajp & re

sid=162/8/1423>

2. Dackis CA, Kampman KM, Lynch KG, Pettinati

HM, O'Brien CP: A

double-blind, placebo-controlled trial of

modafinil for cocaine dependence.

Neuropsychopharmacology 2005;

30:205-211[CrossRef]

<http://ajp.psychiatryonline.org/cgi/external_ref?

access_num=10.1038/sj.npp.

1300600 & link_type=DOI>

3. JR: FDA Warning Letter to M

Kirsch, Senior

Director, Regulatory Affairs, Cephalon Inc re:

NDA #20-717, Provigil

(modafinil) Tablets, MACMIS ID #10183, Jan 14,

2002.

" http://www.pharmcast.com/WarningLetters/Yr2002/Jan2002/Cephalon0102.h

tm "

4. Cephalon Files Application for Marketing

Approval of New

Modafinil Formulation for the Treatment of

Children and Adolescents With

Attention-Deficit/Hyperactivity Disorder. West

Chester, Pa, Cephalon, Dec

21, 2004.

" http://www.drugs.com/NDA/attenace_041221.html "

FAIR USE NOTICE: This may contain copyrighted (C

) material the use of which

has not always been specifically authorized by

the copyright owner. Such

material is made available for educational

purposes, to advance

understanding of human rights, democracy,

scientific, moral, ethical, and

social justice issues, etc. It is believed that

this constitutes a 'fair

use' of any such copyrighted material as provided

for in Title 17 U.S.C.

section 107 of the US Copyright Law. This

material is distributed without

profit.

[Guest guest]

Addictive Qualities of Modafinil Not Discussed by FDA Advisory

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org/cms/

FYI

The focus of a recent FDA's Psychopharmacology

Advisory Committee meeting,

was the drug, modafinil (as Sparlon), for ADHD

and the risk of

-'s, a rare but potentially fatal,

skin condition.

The Committee and the FDA recommended that the

Celaphon provide additional

data about that risk. However, there is concern

about evidence-acknowledged

in the Physician's Desk Reference (i.e., drug

label) that modafinil is

likely to be as 'reinforcing' (i.e., addictive)

as COCAINE.

What in Heaven's name are we doing by encouraging

the prescribing of highly

addictive drugs to our children?

What is the public health justification that

prompts the FDA to support the

prescribing of powerful psychotropic drugs for

children dubiously diagnosed

with ADHD?

In the case of psychostimulants-which FDA's

Pediatric Advisory Committee

examined-the drugs were found to act like

Cocaine: inducing psychosis,

hallucinations, and violence in children.

Like Cocaine, the prescribed drugs for ADHD are

addictive.

The manufacturer's label states:

" PROVIGIL produces psychoactive and euphoric

effects, alterations in mood,

perception, thinking and feelings typical of

other CNS

stimulants....Modafinil is reinforcing, as

evidenced by its

self-administration in monkeys previously trained

to self-administer

cocaine....Adverse experiences that were reported

at these [high] doses

included excitation or agitation, insomnia, and

slight or moderate

elevations in hemodynamic parameters. Other

observed high-dose effects in

clinical studies have included anxiety,

irritability, aggressiveness,

confusion, nervousness, tremor, palpitations,

sleep disturbances, nausea,

diarrhea and decreased prothrombin time. " See:

http://www.biopsychiatry.com/modafinil/modafinil-provigil.pdf

To overcome the documented adverse event profile

disclosed in the label,

drug manufacturers hire academic-affiliated

" experts " to write reports (or

merely sign off on articles) that downplay the

product's adverse effects--or

even deny they exist.

In the case of modafinil, its addictive and

euphoric effect is denied in a

recent report published in the American J of

Psychiatry (August 2005) by Dr.

O'Brien, of the University of

Pennsylvania.

Below, AHRP board member, Dr. Stefan Kruseuzki,

challenges Dr. O'Brien and

the American J of Psychiatry for misrepresenting

the addictive qualities of

modafinil.

Of note, Dr. O'Brien has served as a paid

consultant to Cephalon, the

drug's manufacturer.

See financial disclosure: A Dackis,

M Kampman1, G Lynch1,

Helen M Pettinati1 and P O'Brien

A Double-Blind, Placebo-Controlled Trial of

Modafinil for Cocaine

Dependence, Neuropsychopharmacology (2005) 30,

205-211.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

The American Journal of Psychiatry

March, 2006

Euphorigenic and Abusive Properties of Modafinil

STEFAN P. KRUSZEWSKI, M.D.

burg, Pa.

To the Editor:

In the August issue of the Journal, P.

O'Brien, M.D., Ph.D. (1)

<http://ajp.psychiatryonline.org/cgi/content/full/163/3/549>

stated the

following about modafinil, a drug that he

reported may decrease cocaine use

in some cocaine users: " The medication has not

been reported to produce

euphoria, and there has been no indication of

excessive use or abuse in

clinical trials " (p. 1428). As the scientific

basis for his comment, the

author referenced his own group's work (2) .

The author's statement does not appear to be

supported by his referenced

work, nor is it supported by information widely

available in the 2004

edition of the Physicians' Desk Reference (PDR).

The referenced article, for

example, may demonstrate that modafinil can, in

some cases, blunt cocaine

euphoria. However, it does not say anything about

modafinil's intrinsic

ability to produce euphoria (or not). Separately,

the 2004 PDR raises

specific concerns about modafinil, saying that it

can produce " psychoactive

and euphoric effects, alterations in mood,

perception, thinking and feelings

typical of other CNS stimulants. " The PDR also

states that " modafinil is

reinforcing, as evidenced by its

self-administration in monkeys previously

trained to self-administer cocaine. "

The author's comment about the lack of

euphorigenic effects of modafinil is

also contradicted by the U.S. Food and Drug

Administration (FDA) in its

warning letter of Jan. 14, 2002, sent to M.

Kirsch, the senior director

of regulatory affairs of Cephalon, Inc., the

makers of modafinil. It is

available online (3) . That letter specifically

reiterates the package

insert for modafinil, addressing its abuse

potential and euphorigenic

effects.

That the euphorigenic side effects or abuse

potential may be minimized has

current treatment implications because modafinil

is increasingly promoted

for fatigue and excessive sleepiness unrelated to

narcolepsy as well as for

cocaine abuse. However, the implications loom

even larger because the makers

of modafinil have submitted the " reformulated "

drug to the FDA under a new

name-Attenace-for the treatment of attention

deficit hyperactivity disorder

(4)

References

1. O'Brien CP: Anticraving medications for

relapse prevention:

a possible new class of psychoactive medications.

Am J Psychiatry 2005;

162:1423-1431[Abstract/Free Full Text]

<http://ajp.psychiatryonline.org/cgi/ijlink?

linkType=ABST & journalCode=ajp & re

sid=162/8/1423>

2. Dackis CA, Kampman KM, Lynch KG, Pettinati

HM, O'Brien CP: A

double-blind, placebo-controlled trial of

modafinil for cocaine dependence.

Neuropsychopharmacology 2005;

30:205-211[CrossRef]

<http://ajp.psychiatryonline.org/cgi/external_ref?

access_num=10.1038/sj.npp.

1300600 & link_type=DOI>

3. JR: FDA Warning Letter to M

Kirsch, Senior

Director, Regulatory Affairs, Cephalon Inc re:

NDA #20-717, Provigil

(modafinil) Tablets, MACMIS ID #10183, Jan 14,

2002.

" http://www.pharmcast.com/WarningLetters/Yr2002/Jan2002/Cephalon0102.h

tm "

4. Cephalon Files Application for Marketing

Approval of New

Modafinil Formulation for the Treatment of

Children and Adolescents With

Attention-Deficit/Hyperactivity Disorder. West

Chester, Pa, Cephalon, Dec

21, 2004.

" http://www.drugs.com/NDA/attenace_041221.html "

FAIR USE NOTICE: This may contain copyrighted (C

) material the use of which

has not always been specifically authorized by

the copyright owner. Such

material is made available for educational

purposes, to advance

understanding of human rights, democracy,

scientific, moral, ethical, and

social justice issues, etc. It is believed that

this constitutes a 'fair

use' of any such copyrighted material as provided

for in Title 17 U.S.C.

section 107 of the US Copyright Law. This

material is distributed without

profit.

[Guest guest]

Addictive Qualities of Modafinil Not Discussed by FDA Advisory

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org/cms/

FYI

The focus of a recent FDA's Psychopharmacology

Advisory Committee meeting,

was the drug, modafinil (as Sparlon), for ADHD

and the risk of

-'s, a rare but potentially fatal,

skin condition.

The Committee and the FDA recommended that the

Celaphon provide additional

data about that risk. However, there is concern

about evidence-acknowledged

in the Physician's Desk Reference (i.e., drug

label) that modafinil is

likely to be as 'reinforcing' (i.e., addictive)

as COCAINE.

What in Heaven's name are we doing by encouraging

the prescribing of highly

addictive drugs to our children?

What is the public health justification that

prompts the FDA to support the

prescribing of powerful psychotropic drugs for

children dubiously diagnosed

with ADHD?

In the case of psychostimulants-which FDA's

Pediatric Advisory Committee

examined-the drugs were found to act like

Cocaine: inducing psychosis,

hallucinations, and violence in children.

Like Cocaine, the prescribed drugs for ADHD are

addictive.

The manufacturer's label states:

" PROVIGIL produces psychoactive and euphoric

effects, alterations in mood,

perception, thinking and feelings typical of

other CNS

stimulants....Modafinil is reinforcing, as

evidenced by its

self-administration in monkeys previously trained

to self-administer

cocaine....Adverse experiences that were reported

at these [high] doses

included excitation or agitation, insomnia, and

slight or moderate

elevations in hemodynamic parameters. Other

observed high-dose effects in

clinical studies have included anxiety,

irritability, aggressiveness,

confusion, nervousness, tremor, palpitations,

sleep disturbances, nausea,

diarrhea and decreased prothrombin time. " See:

http://www.biopsychiatry.com/modafinil/modafinil-provigil.pdf

To overcome the documented adverse event profile

disclosed in the label,

drug manufacturers hire academic-affiliated

" experts " to write reports (or

merely sign off on articles) that downplay the

product's adverse effects--or

even deny they exist.

In the case of modafinil, its addictive and

euphoric effect is denied in a

recent report published in the American J of

Psychiatry (August 2005) by Dr.

O'Brien, of the University of

Pennsylvania.

Below, AHRP board member, Dr. Stefan Kruseuzki,

challenges Dr. O'Brien and

the American J of Psychiatry for misrepresenting

the addictive qualities of

modafinil.

Of note, Dr. O'Brien has served as a paid

consultant to Cephalon, the

drug's manufacturer.

See financial disclosure: A Dackis,

M Kampman1, G Lynch1,

Helen M Pettinati1 and P O'Brien

A Double-Blind, Placebo-Controlled Trial of

Modafinil for Cocaine

Dependence, Neuropsychopharmacology (2005) 30,

205-211.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

The American Journal of Psychiatry

March, 2006

Euphorigenic and Abusive Properties of Modafinil

STEFAN P. KRUSZEWSKI, M.D.

burg, Pa.

To the Editor:

In the August issue of the Journal, P.

O'Brien, M.D., Ph.D. (1)

<http://ajp.psychiatryonline.org/cgi/content/full/163/3/549>

stated the

following about modafinil, a drug that he

reported may decrease cocaine use

in some cocaine users: " The medication has not

been reported to produce

euphoria, and there has been no indication of

excessive use or abuse in

clinical trials " (p. 1428). As the scientific

basis for his comment, the

author referenced his own group's work (2) .

The author's statement does not appear to be

supported by his referenced

work, nor is it supported by information widely

available in the 2004

edition of the Physicians' Desk Reference (PDR).

The referenced article, for

example, may demonstrate that modafinil can, in

some cases, blunt cocaine

euphoria. However, it does not say anything about

modafinil's intrinsic

ability to produce euphoria (or not). Separately,

the 2004 PDR raises

specific concerns about modafinil, saying that it

can produce " psychoactive

and euphoric effects, alterations in mood,

perception, thinking and feelings

typical of other CNS stimulants. " The PDR also

states that " modafinil is

reinforcing, as evidenced by its

self-administration in monkeys previously

trained to self-administer cocaine. "

The author's comment about the lack of

euphorigenic effects of modafinil is

also contradicted by the U.S. Food and Drug

Administration (FDA) in its

warning letter of Jan. 14, 2002, sent to M.

Kirsch, the senior director

of regulatory affairs of Cephalon, Inc., the

makers of modafinil. It is

available online (3) . That letter specifically

reiterates the package

insert for modafinil, addressing its abuse

potential and euphorigenic

effects.

That the euphorigenic side effects or abuse

potential may be minimized has

current treatment implications because modafinil

is increasingly promoted

for fatigue and excessive sleepiness unrelated to

narcolepsy as well as for

cocaine abuse. However, the implications loom

even larger because the makers

of modafinil have submitted the " reformulated "

drug to the FDA under a new

name-Attenace-for the treatment of attention

deficit hyperactivity disorder

(4)

References

1. O'Brien CP: Anticraving medications for

relapse prevention:

a possible new class of psychoactive medications.

Am J Psychiatry 2005;

162:1423-1431[Abstract/Free Full Text]

<http://ajp.psychiatryonline.org/cgi/ijlink?

linkType=ABST & journalCode=ajp & re

sid=162/8/1423>

2. Dackis CA, Kampman KM, Lynch KG, Pettinati

HM, O'Brien CP: A

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