|
Strattera
(atomoxetine)
One of the Newer Drugs for
ADD and ADHD
Most recently updated:
Sunday January 22, 2012
Strattera is the latest drug for ADD/ADHD from
the Eli Lilly Company.
It became available in pharmacies in January 2003.
Strattera however has several interesting
features that makes it of great interest.
1. It is not a Schedule II drug. That
means that your physician can now:
a. Give free samples
b. Write a prescription for more than a month at a time
c. Call prescriptions into the pharmacy, rather than
requiring you
to pick them up each month
2. Less abuse potential. It appears to have no abuse potential if it ends up in the hands of someone who
who would wish to abuse it. It does not become addicting in high doses.
3. It is not a stimulant. Rather it is an
NRI, an norepinephrine reuptake inhibitor. Norepinephrine has
been known to play a key role in ADHD and depression for a long time. Some
of the older antidepressants that impact norepinephrine, such as imipramine (Tofranil) and desipramine
(Norpramin) have been used for the treatment of ADHD. However their side effect profile is quite severe,
and requires close monitoring for heart rhythm problem. Thus careful monitoring
should be done. In addition, those
older antidepressants cause many physically uncomfortable side effects, such as
dry mouth.
4. It is the only drug that has specifically
been approved by the FDA for adults. This is more a big deal for the Lilly
Company than anyone else. It is the only drug that can legally be marketed
to help adult ADHD. Remember, that it is quite proper for a physician to use a
drug for purposes other than what has been approved by the FDA. So adults
have many choices other than Strattera.
5. It may also be more easily prescribed to
those adolescents and adults who are "addiction prone." There has always been a
great concern for giving stimulants to those who have problems with alcohol or
drugs. This has unfortunately kept many people away from treatment, since
it is well known substance abuse is a great risk factor for those with ADHD.
This may open the door for many more people for treatment. Strattera does not
stimulate the pleasure centers of the brain as do the stimulants.
6. It appears to provide 24-hours per day
coverage. The stimulants last no longer than part of a day, ranging
from 4-12 hours. Since Strattera carries
over until the next day, this will help the "getting going" that is so difficult
with most people with ADHD.
7. Since it has antidepressant properties, it
may provide especially effective treatment for those with depressive and anxious
features alongside ADD/ADHD.
8. It does not appear to make tics or Tourette's
Syndrome worse, as the stimulants often do.
Strattera may be administered in either a once or twice a day dosing
. A morning and late afternoon dosing schedule appears to have been
used in most of the clinical trials. However, once a day appears to work well.
It doesn't seem to be so critical on the exact timing of the dosage.
The dosage in the child-adolescent studies were
based on weight. The dosage that seemed to be started was at .5 mg/kg/day.
The most effective dose appeared to be about 1.2 to 1.4 mg/kg/day. For adolescents,
regardless of weight, the maximum dosage appears to be recommended to not exceed
80 mg for the first month or so, and then perhaps go up to 100 mg per day.
Adults appear to need 80 mg to 100 mg per day if they weigh more than 175 pounds
or so.
Consult with your physician before adjusting the
dosage as this information is preliminary and based on Eli Lilly dosing
instructions. It appears that most physicians are being very cautious and thus underdosing. This will be quite noticeable with people who have been on
stimulants. It also appears to take a while for Strattera to start working. It
might be advisable to continue the stimulant, and then taper it as the impact of
Strattera is made.
Poor metabolizers of
the drug appeared to have the most positive impact.
Strattera
Dosing Charts
Now that Strattera has been on the market for
several years, the side effects are becoming better known. The most noticeable
side effect appears to be sleepiness.
The side effects appear to be somewhat
more common than with
the psychostimulant medications. The primary concerns appear to still be
appetite suppression, sleep disruption (insomnia), and an increase in
heart rate and blood pressure. There have been some reports of rapid heart
rate (tachycardia). As with the psychostimulant medications,
side effects appear to resolve when the medication is stopped. Generally the appetite suppression that is such
a problem in the stimulants seem to be minimal with Strattera.
Overall, there appears to be more
side-effects with Strattera than was originally promised or hoped for. There
seems to be a lot more people trying it and discontinuing it. There are also a
fair number of people who seem to have minimal or no benefit from Strattera.
There seem to be a lot of anecdotal
reports of daytime sleepiness that appears bothersome for many people. This
may be related to the fact that most of the drug trials used twice a day dosing,
but then Eli Lilly decided that once a day dosing was therapeutically equivalent
to twice a day dosing. So to overcome drowsiness, one strategy may be to switch the time of dosing to
evening, or split dosing to twice a day.
An interesting, but apparently
harmless side effect, is enlarged pupils. For some reason that has not been
widely mentioned, but some parents have expressed concern, and one parent
reported to this author that the teacher commented about it. This could be
mistaken for illegal substance abuse, when it appears that norepinephrine is
responsible for that effect.
Prozac and Paxil are inhibitors of the
metabolism of Strattera. For that reason, it is best to be very careful when
using Strattera with either of those. The
recommendation seems to be to start at .5 mg/kg/day if the person is using
either Prozac or Paxil.
Males have reported some problems with
genito-urinary side effects. Symptoms similar to prostatitis have been reported.
Painful urination and urinary retention have occurred. Some of the chat rooms
have indicated pain and unusual symptoms following sexual intercourse.
It has been shown to be effective in a variety
of settings and studies. It has been demonstrated to improve the ADHD and
ADD symptoms in children, adolescents and adults. It may also have special
effectiveness for people who have depressive symptoms.
The FDA does not require that a medication be
better than another medication on the market. It merely has to be better than
placebo. So the fact that Strattera works for ADHD does not mean that it is
superior to other medications.
Strattera appears to become effective within a
couple of days to one week, and may be somewhat effective prior to reaching its
optimal dose. Some people suggest waiting 4-6 weeks before deciding that the dosage is ineffective.
It seems to impact nicely "quality of life"
issues. Several parents have said, "I like my child better." One mother and son
sat in my office kidding each other, something that had never happened before.
This may be attributable to its antidepressant properties.
It may help with executive functioning issues
better than the stimulants.
Overall, Strattera appears to have a
somewhat weaker impact than the stimulants. This may be noticeable on those who
have a "sluggish cognitive tempo." It may not impact hyperactivity as much as is
necessary.
In reality many psychiatrists are using it
alongside the stimulant medications.
The following may be some disadvantages:
1. There may be too little follow-up with
it. Presently there is rarely enough follow-up with the stimulant
medications to make sure that the person is doing as well as possible. The
ease of prescribing is likely to create a situation of too little follow-up.
In the long run that leaves many people disappointed in the treatment of ADHD.
A recent study indicated that the average person who received medication for
their ADHD child reported no significant improvement after one year. That
is caused almost entirely by inadequate monitoring, follow-up, and learning to
understand the nature of ADHD.
2. This is no great cure all. No one drug
will help everyone. It is still
going to have some of the side-effects of the stimulants, without the "bad name"
of the stimulants. And it will surely be ineffective for some people.
3. Any new drug means that the exact way it will
work in the "real world" is not yet known. Many people who will take the
drug would have been excluded for certain reasons in the studies. Typical
studies eliminate "complicated cases." In real life, there are many issues
to deal with in a given person.
4. It is not necessarily safer in the long run
than the stimulants. People fear the long-term side effects of the
stimulant drugs. But Ritalin has been used for over 30 years with
extremely few known side effects. The long-term side effects of Strattera
is obviously totally unknown.
5. Cost and Insurance constraints. Some
insurance companies are refusing to pay for it. And if you have to pay for it
out of pocket...it is quite pricey. A recent check with a local pharmacy
indicated that #30 60 mg pills cost over $100, and #60 40 mg pills cost over
$200 (to get the 80 mg dosage)!!! The pharmacist said, "No one pays for these
out of pocket!"
6. One may need to add a stimulant along side of
it. Strattera does not seem to impact hyperactivity as much as the stimulant
medications. That tends to defeat the argument that you can avoid a Schedule II drug.
7. It appears difficult to adjust. One
psychiatrist stated recently somewhat to the effect: "With the stimulants I knew
within a couple of months how they worked and what to expect. With Strattera, I
believe that a year from now I still won't have a really good handle on it. It
may well become a drug for psychiatrists, rather than primarily care physicians,
since it is so complicated to use."
For more information you may wish to go to these websites:
Strattera.com This is the website
sponsored by the Eli Lilly Company that makes and markets the drug. It has good
information, but obviously they will only tell you the advantages. The FDA
also regulates what they are able to say about the drug.
Psychopharmacology Alert's Review of the Clinical Trials that led to FDA
approval of Atomoxetine (Strattera). This review from Manessis Communications is
the best summaries that Mr. Swank has found to date with some detail about the
study parameters, dosages used, side effects and results.
While admittedly sponsored by Eli Lilly, the makers
of Strattera, Floyd Sallee, MD and Ph. D. (Professor of Psychiatry and
Pediatrics) at Cincinnati
Children's Medical spoke of his experience as part of the drug trials for
Strattera. He made the following points that I found helpful:
1. While Strattera has a half-life of about 5.2
hours, and targets primarily norepinephrine, the drug indirectly impacts
dopamine action that continues beyond the time the drug is in the system. Thus
one a day dosing is all that is necessary in most cases.
2. Dosing levels are very conservative if one
follows the FDA dosing guidelines. The FDA does not suggest above 100 mg/
day. That may not be high enough for patients who weigh more. A
1.4-1.6 mg/kg/day formula may be a more realistic target dosage. Dosages
up to 200 mg/day may not be unreasonable. Dr. Salle does not feel that there are
any significant risk even with overdosage.
3. The only 2 psychotropic drugs to worry about
taking with Strattera are Prozac and Paxil (Well, and the MAO inhibitors which
are extremely rarely used). Use smaller doses when using along side them.
4. There is no problem using Strattera along side
the psychostimulants such as Ritalin, Concerta, Metadate or Adderall.
5. Strattera appears to carry over to the next
morning, impacting in a positive manner.
6. Strattera is rapidly absorbed, with maximal
plasma levels reached in 1-2 hours after dosing.
7. Strattera has been found to be helpful with tic
disorders comorbid with ADHD. Does not exacerbate tics or Tourette's Syndrome.
8. Regarding how long before it makes an impact is
fairly rapid, a conservative approach should be to wait two weeks once one has
reached a normal optimal dosage before increasing again.
9. A starting dosage of about .5 mg/kg/day should
be increased to target dosage after about 3-4 days. This helps minimize the
impact of side effects if started with a full dosage.
10. Strattera does not appear to potentiate the
impact of alcohol.
11. While chemically different than Prozac, it may
be helpful to think of it as a cousin of Prozac in terms of the way it works.
However, its action is very specific to norepinephrine. It also appears to
target most specifically the prefrontal cortex of the brain, which is the main
brain center implicated in executive function and ADHD problems.
12. There are some reports of sexual dysfunction
side effects in adult use.
Hope this is helpful,
John Swank
Notes from Rick Bowers (MD, Psychiatrist) at Eli
Lilly Sponsored symposium about Strattera held 03-04-03 in Troy, Ohio
1. Strattera may take 3-6 weeks to have full
impact. During the time from starting medication until it takes full effect,
there may be a noticeable gap of efficacy if the person has been on a
psychostimulant medication. Thus one may want to keep the psychostimulant
medication for a while until the Strattera reaches optimal impact. A tapering
strategy may be the best. Thus may leave them on the stimulant for about two
weeks before tapering off the psychostimulant. Dr. Bowers seemed to indicate
that there was about a 25% impact in the first week, compared to full impact 3-6
weeks out.
2. Side effects tend to resolve after a week or two
for most people.
3. The ideal candidates for Strattera may be:
a. Those people where regular medications have not been
effect.
b. Those people who have side effects to stimulants: sleep,
appetite, dysphoria, tics, personality blunting
c. Difficulty dispensing for fear for diversion, or out of
town college students
d. Those with poor efficacy in the AM or PM, since Strattera
seems to have carry-over effect.
4. If side effects, try dispensing with food (such
as peanut butter), BID dosing or bedtime dosing if sleepiness is a problem
5. Using Strattera along side of stimulants may be
necessary.
6. Dr. Bowers prefers a rotation strategy when
starting medications, using trials of methylphenidate products, Adderall, and
now Strattera. If one does not try all, one does not really know which one
works best.
7. Strattera seems to be quite helpful with the
functional or family interaction issues related to problems with ADHD or
Oppositional Defiant Disorder.
8. It may have some really helpful benefits in the
hard to treat Autistic/Asperger's/Pervasive Developmental Disorder population.
9. Dr. Bower's reported his experience that when
used with Prozac or Paxil, that the dosage of Strattera needs to be cut about in
half.
Other helpful comments:
Dr. Bowers pointed out that Ohio law allows
physicians to write 3 month of stimulant medications at one time. The date that
the prescription is written must be the date written, but one can write three
different prescriptions for the three following months that state that they may
not be filled until a certain date.
Focalin is sometimes helpful with fewer side
effects than other stimulants that have proven to be bothersome.
Notes and responsibility for errors by John Swank. 03-04-03
© 2011
John E. Swank, MS, LPCC Swank Counseling , 21
Robinhood Lane, Troy, OH
45373
| 
Swank Counseling
(new)
