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Strattera (Atomoxetine Hydrochloride) - Summary



Suicidal Ideation in Children and Adolescents — STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.

Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials. (See WARNINGS and PRECAUTIONS, Pediatric Use).



STRATTERA®(atomoxetine HCl)

STRATTERA® (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor.

STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The effectiveness of STRATTERA in the treatment of ADHD was established in 2 placebo-controlled trials in children, 2 placebo-controlled trials in children and adolescents, and 2 placebo-controlled trials in adults who met DSM-IV criteria for ADHD ( see CLINICAL STUDIES).

A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, "on the go," excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.

The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

The effectiveness of STRATTERA for long-term use, ie, for more than 9 weeks in child and adolescent patients and 10 weeks in adult patients, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use STRATTERA for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION).

See all Strattera indications & dosage >>


Published Studies Related to Strattera (Atomoxetine)

Drug-specific laterality effects on frontal lobe activation of atomoxetine and methylphenidate in attention deficit hyperactivity disorder boys during working memory. [2014]
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX

Atomoxetine improved attention in children and adolescents with attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute, randomized, double-blind trial. [2013]
working memory, life performance, and self-concept... CONCLUSIONS: Atomoxetine treatment improved ADHD symptoms in subjects with ADHD+D

A meta-analysis of the consistency of atomoxetine treatment effects in pediatric patients with attention-deficit/hyperactivity disorder from 15 clinical trials across four geographic regions. [2013]
geographic regions... CONCLUSIONS: Atomoxetine was demonstrated as an effective treatment for ADHD in

Does atomoxetine improve executive function, inhibitory control, and hyperactivity? Results from a placebo-controlled trial using quantitative measurement technology. [2012]
The primary objective of this study was to evaluate the efficacy of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD)-related symptoms assessed as standard variables of a computer-based continuous performance test (cb-CPT) combined with a motion-tracking (MT) device... The results of this study show that ATX for 8 weeks significantly reduced ADHD-related symptoms as measured by the cb-CPT/MT.

A randomized double-blind study of atomoxetine versus placebo for attention-deficit/hyperactivity disorder symptoms in children with autism spectrum disorder. [2012]
CONCLUSIONS: Atomoxetine moderately improved ADHD symptoms in patients with ASD

more studies >>

Clinical Trials Related to Strattera (Atomoxetine)

Atomoxetine, Placebo and Parent Management Training in Autism [Recruiting]
The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.

Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI) [Recruiting]
Atomoxetine is the only medication that is currently approved by the FDA for the treatment of attention deficit hyperactivity disorder in adults. It has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (TBI), but it's effectiveness in this population has not been studied. There are a number of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. This study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with TBI

A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia [Completed]
This study proposes to examine the effect of atomoxetine on quality of life and negative symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat emotions, slowed body movements and lack of drive and motivation in patients with schizophrenia or schizoaffective disorder. This study also examines the safety of using atomoxetine along with the conventional antipsychotic in these patients.

Atomoxetine and Parent Management Training in Treating Children With Autism and Symptoms of Attention Deficit Disorder With Hyperactivity [Recruiting]
This study will evaluate the effectiveness of the medication atomoxetine, with and without parent management training, in treating children with autism or pervasive developmental disorder not otherwise specified who have symptoms of attention deficit hyperactivity disorder.

Atomoxetine and Huntington's Disease [Active, not recruiting]
The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early HD and attention deficit disorder.

more trials >>

Reports of Suspected Strattera (Atomoxetine) Side Effects

Suicidal Ideation (54)Aggression (28)Electrocardiogram QT Prolonged (20)Nausea (18)Headache (16)Vomiting (16)OFF Label USE (15)Anxiety (15)Depression (14)Irritability (13)more >>


Based on a total of 18 ratings/reviews, Strattera has an overall score of 6.17. The effectiveness score is 7 and the side effect score is 6.56. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Strattera review by 26 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   ADHD
Dosage & duration:   60 mg taken once daily for the period of 4 YRS
Other conditions:   None
Other drugs taken:   ALLEGRA
Reported Results
Benefits:   Stratterra enabled me to concentrate and focus on tasks at hand. It makes a world of difference in my daily life. After four years of using Stratterra, I would never switch to a different ADHD medication.
Side effects:   Stratterra surpresses my appetite and makes me feel quite dependent on the drug to function. If I take with my multivitamin, I often feel nauseous.
Comments:   I take 1 60 mg of Stratterra in the morning daily.


Strattera review by care giver of 51 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   ADHD
Dosage & duration:   20 -25 mg taken 1 x day for the period of 2 tears
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   Slowed down hyperactivity in a nine year old boy; increased attending a little bit although not strongly. It does not interfere with sleep which many of the stimpulant meds do. There were no mood swings until the dosage was increased.
Side effects:   When the dose was raised, the patient suffered suicidal ideation! This was bad. At lower dose it seemed to be ok. Dosage takes 2-3 weeks to take affect. Side effects also will not be observed until dose builds up in the system. You may see lesser instances of self denegration first. Watch for that.
Comments:   Take pill once a day


Strattera review by 21 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   ADHD
Dosage & duration:   10mg taken 1/day for the period of 8 days
Other conditions:   IDDM
Other drugs taken:   insulin
Reported Results
Benefits:   none
Side effects:   visual disturbances, weight gain, insomnia, anxiety, hyperglycemia, headaches, mild hallucinations, water retention, difficulty concentrating, memory lapses, erratic behaviour. these side effects lasted for several weeks after I stopped taking the medication, and my vision did not return to normal for almost a month. my doctor said it was an anti-cholinergic reaction.
Comments:   i started at a very low dose, to be worked up gradually. treatment ended before this could happen.

See all Strattera reviews / ratings >>

Page last updated: 2014-12-01

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