Stimulant compounds are often prescribed for people with ADHD, and if used properly under the close supervision of a physician, the drugs can be beneficial. Adderall and AdderallXR, amphetamine compounds, are the registered trademarks of Shire, Inc., a pharmaceutical company located in Florence, Kentucky. Adderall is a central nervous stimulant that is used to treat ADHD in children 6 years of age and older and in adults.

The mode of therapeutic action of the stimulants is not exactly known. The neurotransmitters norepinephrine and dopamine are thought to be involved in the development of the symptoms of ADHD. These stimulant drugs are thought to block the reuptake of the neurotransmitters. The drugs are part of a class called noncatecholamine sympathomimetic amines, which affect the release of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into extraneuronal space (or space outside the neurons), where the transmitters are not effective.

The drug is administered as Adderall tablets, which are mixed amphetamine salts with immediate release available in 5-, 7.4-, 10-, 10.5-, 12.5-, 15-, 20-, and 30-mg doses. The drug is also available in Adderall XR capsules, which are mixed amphetamine salts with extended release available in 5-, 10-, 15-, 20-, 25-, and 30-mg doses. The salts include dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate USP, and amphetamine sulfate USP, in different amounts according to the dosage strength.

Adderall should be taken by mouth in the morning with or without food exactly as the health care professional prescribes. The capsules may be taken whole, or the contents may be sprinkled on a spoonful of applesauce. It is recommended to take the drug immediately without chewing. It is not recommended to take the drug later in the afternoon because of the potential for insomnia. Immediate release Adderall reaches maximum potential in about 4 hours and in Adderall XR in about 7 hours.

Adderall has been tested in clinical trials. A double-blind, randomized, placebo-controlled, parallel-group study was conducted in 584 children aged 6-12 who met DSM-IV criteria for ADHD (either the combined type or the hyperactive-impulsive type). (Clinical Trials and Medical Approval.) A double-blind randomized trial means that neither the scientist nor those administering the drug knows who is getting the drug or a placebo and the participants have been chosen at random with no bias of who would be in what class. A placebo is a pill that is made to look just like the study pill but does not have any of the active ingredients. A parallel study means that it was conducted at the same time. Patients were randomized to receive doses of 10, 20, or 30 mg or placebo in the morning for 3 weeks. Significant improvements in patient behavior, based on teacher rating of attention and hyperactivity, were observed for all Adderall XR compared to patients who received placebo. Those in the study group showed behavioral improvements in both morning and afternoon assessments compared to patients on placebo. A similar study was conducted on 255 adults, who met the Diagnostic and Statistical Manual (DSM-IV-TR) criteria for ADHD. Significant improvements, measured with the ADHD-RS, an 18-item scale that measures the core symptoms of ADHD, were compared to those who received placebo for 4 weeks. There was no adequate evidence that doses greater than 20 mg/day conferred additional benefit.

What are the risks? There are several groups that should not take Adderall: people with a heart defect or other heart problems and those with overactive thyroids, glaucoma, or a history of drugs abuse. Also, someone who has taken a drug called a monoamine oxidase inhibitor (MAOI) to treat depression or one who has stopped taking the MAOI in the last 14 days should not take Adderall. MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marpan (isocarboxid), and other brands. Taking Adderall close in time to an MAOI can result in serious, sometimes fatal reactions, including high body temperature, coma, and seizures.

There are several risks for taking Adderall. Health Canada suspended marketing of Adderall in February 2005 because of reports of sudden unexplained death (SUD) in children taking the drugs. SUD has been associated with amphetamine abuse and has been reported in children with underlying cardiac abnormalities who were taking recommended doses of amphetamines. In addition, a small number of cases of SUD have been reported in children without structural cardiac abnormalities. However, the U.S. Food and Drug Administration (FDA) did not conclude that recommended doses of Adderall can cause SUD, but continued to monitor the data. In August 2005 Health Canada announced that they were returning the drug to the market but would revise the Canadian Product Monograph to include warming about the misuse of Adderall and that it should not be generally used in patients with structural cardiac abnormalities.

The term ''black box warning'' is used for a warning of serious potential and is written on a sheet of information that is placed in the package insert for physicians. The information is inserted in a box surrounded by black lines and is written in capital letters. The following is the black box warning for Adderall and Adderall XR:

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for nontherapeutic use for distribution to others, and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

In February 2006, the FDA warned of several serious cardiac and cardiovascular risks including sudden unexplained death associated with the use of amphetamine or dextroamphetamine in children, adolescents, and adults. In addition to sudden death and abuse potential, additional risks include the following:

- Worsening mental illness or psychosis. Adderall may make symptoms of existing mental illness worse.

- Possible decreased growth and weight loss. Adderall may decrease growth and cause weight loss. Children who take it for a long time should have their growth and body weight measured regularly.

- Increased tics. Adderall may worsen tics and Tourette's disorder.

- Pregnancy. A woman who is pregnant should not take Adderall. The baby may be premature or have a low birth weight. Also, the baby may show withdrawal symptoms, such as agitation and drowsiness.

- Breast feeding. A mother should not take Adderall while breast feeding because the drug can pass into the breast milk.

Other side effects include loss of appetite, difficulty sleeping, dry mouth, headaches, and mood changes. The physician should be told immediately if the person taking the medication has any of these symptoms or medical conditions. What are the interactions with other drugs or foods? Adderall may interact with other medicines, which may cause serious side effects. The physician should be told about all medicines, vitamins, and herbal supplements that one is taking, especially the following:

- Medicines used to treat depression known as tricyclic antidepressants and MAOIs

- Antacids, including over-the-counter medicines

- Medicines used to treat urinary problems

- Diuretics

- Pain killers such as Darvon and Darvocet that contain propoxyphene.

Individual patients differ in their response to amphetamines. Toxic symptoms may occur at low doses. Overdosage should be treated as with any poison. Consult a Certified Poison Control Center. Specialists at the center may use stomach lavage or washing out the contents of the stomach, administer activated charcoal, and administer a cathartic and sedative.

Bibliography:

''Adderall Package Insert.'' U.S. Food and Drug Administration

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