Story highlights More than a quarter of U.S. kids and teens now take regular medication

About 1 in 5 children ages 13 to 18 has some sort of mental disorder

These medicines are not meant to be a quick solution for stressed-out families

As the sun rises over Phoenix, 4-year-old Shelby wakes. She sleepily uses the potty, dutifully washes her hands, and then accepts a white capsule from her mother, Victoria*. (*Last name has been withheld.)

The blond-haired, blue-eyed little girl swallows the medicine easily. "And then she's off—to take care of the pets, play with play dough, and just be Shelby," says Victoria.

The capsule contains 20 milligrams (mg) of Ritalin (methylphenidate), the prescription stimulant used to calm and focus children with attention deficit hyperactivity disorder (ADHD). After dinner, Shelby takes more meds -- 2.5 mg of Abilify and .05 mg of clonidine. The preschooler has been on daily medication since she was 2, when she slept only about four hours a night and threw frequent, violent temper tantrums that sometimes left her mother with bruises and bite marks.

A psychiatrist at the local children's hospital diagnosed bipolar disorder. For a year, Shelby was on increasingly potent doses of Risperdal (risperidone), an antipsychotic, and Depakote (divalproex), an antiseizure drug that's also used to reduce mania.

But as her outbursts gave way to medication side effects including slurred speech, tremors, weight gain, and an inability to walk without stumbling, her mother sought another opinion. This psychologist disagreed with the initial diagnosis, suggesting that Shelby didn't have bipolar disorder but rather a combination of ADHD and oppositional defiant disorder (ODD). He prescribed Ritalin.

Two-year-olds being diagnosed with bipolar disorder and put on psychiatric meds? It sounds incredible, but across the country children are learning to swallow pills before they can tie their shoelaces.

A 2007 study found about one preschooler in 70 was taking a psychiatric drug, such as a stimulant, an antidepressant, a mood stabilizer, an antipsychotic, or an antianxiety drug, says Mark Olfson, M.D., a Columbia University psychiatrist and researcher.

While some doctors have been prescribing drugs to treat attention deficits and depression in very young children for more than a decade now, the use of antipsychotics to counter irritability and aggression in this age group is new.

The change may be part of a larger trend of prescribing drugs -- for any condition -- to children. More than a quarter of U.S. kids and teens now take regular medication, according to Medco Health Solutions, Inc., the biggest U.S. pharmacy-benefit manager.

In spite of the growing number of young kids taking psychiatric drugs, these medications (with a few exceptions) are not specifically approved by the Food and Drug Administration for use in children under age 6. Why? Because little is known about how they affect the tiny brains and bodies of young children.

"We have very little research to show how psychiatric medications affect the developing nervous system, for instance," says Dr. Olfson. "This is a concern."

What is known: Some medications carry significant side effects. Stimulants may be associated with a slower rate of growth when used consistently over several years. Antipsychotics are linked to rapid weight gain and metabolic and endocrine abnormalities.

In one study, kids ages 2 to 6 gained an average of 19 pounds in less than 12 weeks on one antipsychotic-drug regimen. But even with these side effects, doctors defend the drugs' use in the most severe cases.

"This doesn't mean children shouldn't be on these medications -- many have benefits that outweigh the risk of side effects," says Rachel Klein, M.D., director of the Anita Saltz Institute for Anxiety and Mood Disorders at New York University. "It does mean you need to be really careful to monitor kids who are on these drugs."

For parents whose lives have been turned upside down by intensely moody or rebellious toddlers and preschoolers, the psychiatric drugs can seem heaven-sent.

"My son used to be a ticking time bomb -- he'd find a screwdriver and poke a hole in the screen door, then stuff a toy down the toilet in a matter of minutes," says Theresa Newfield of Raynham, MA, whose son Dayson was diagnosed with ODD when he was 3. Now on the stimulant Adderall (amphetamine and dextroamphetamine) by day and an antidepressant before bed,

"Dayson can actually focus on what you're saying and reply with a sensible thought," she says.

Last year The New York Times reported on a boy named Kyle who started taking an antipsychotic drug when he was just 18 months old, prescribed by a physician trying to control the boy's severe temper tantrums. The article documented the child's journey from doctor to doctor, diagnosis to diagnosis, until, by the time he was 3, he was taking an antipsychotic, an antidepressant, two sleeping medicines, and a drug for attention deficit hyperactivity disorder. Now 7, the boy was finally weaned off all meds but one -- for ADHD -- through a program administered by the state of Louisiana in partnership with Tulane clinicians.

"The rate that children are being medicated is increasing out of proportion to research showing that it's safe and effective," says Mary Margaret Gleason, M.D., assistant professor of psychiatry and behavioral sciences at Tulane University School of Medicine. "At the same time, we know that kids need help." Dr. Gleason, who treated Kyle as he was weaned off the heavy medications, said there was no valid reason to give antipsychotic drugs to the boy...or virtually any other 2-year-old.

About 1 in 5 children ages 13 to 18 has some sort of mental disorder, be it an anxiety, mood, or disruptive behavior disorder, according to researchers at the National Institutes of Health. The rate of problems in preschoolers is not much less than that of teens, says Dr. Gleason. That means there are a lot of children who desperately need help. But are these medications the best way for them to get it?

At the heart of the controversy over medicating little kids is disagreement over how to characterize and diagnose psychiatric disorders in this group. Doctors may need to use developmentally different criteria to define some disorders because symptoms may present differently in young children.

After all, whether it's a kicking fit in the candy aisle, an unprovoked smack of a sibling, or a sobbing session over a lost barrette, almost all preschoolers and toddlers can behave in ways that seem, well, a little crazy. That's because the parts of the brain that regulate emotion are still being formed.

"Many symptoms that are abnormal in adults may be typical in children," says Dr. Gleason. "Crying might be a sign of depression -- or just of being three years old."

Most specialists agree that some children are so consistently restless, moody, or fearful that they can legitimately be diagnosed with ADHD, ODD, depression, or anxiety. But scientists are still working out how symptoms in young children are different than those in older kids or grown-ups.

For example, Washington University researcher Joan Luby, M.D., has pointed out that depressed preschoolers usually don't talk about suicide, but they may act out morbid themes during play. The growing diagnosis in young children of bipolar disorder, which is characterized by long periods of energy followed by long periods of depression, is especially controversial.

"Preschoolers don't have good months and then bad months the way adults do," says Dr. Klein. "They may have a problem, but it's probably not bipolar."

To get the right diagnosis, parents need to consult the right expert: a child psychiatrist or psychologist with a background in pediatric mental health, according to the American Academy of Child & Adolescent Psychiatry (AACAP). The specialist should observe the child over many hours, especially the way he interacts with his parents, and collect a complete history, including a report from at least one person outside the home, such as a teacher. Easier said than done. There are fewer than 10,000 child and adolescent psychiatrists in the U.S., as well as a shortage of child psychologists.

"There are so few doctors who see children under five. You wait two months for an appointment and they might look at your child for ten minutes," says Victoria, Shelby's mom.

"Therapy Can Be More Expensive"

Once a toddler or preschooler is diagnosed with a mental disorder by a qualified expert, his parents face daunting decisions. Although nearly all doctors recommend that psychotherapy be tried before medications, some doctors are quicker than others to recommend drugs, and while the use of psychiatric medications has been rising, the use of non-pharmacological treatments has decreased.

"Unfortunately, weekly therapy sessions take more time and work than filling a prescription and checking back in with a psychiatrist once a month," says Dr. Gleason. "And the way insurance companies negotiate rates, therapy can also be more expensive for families than pills, at least in the short term."

Some doctors and parents don't necessarily see this as a bad thing, and argue that there are times when medication can make all the difference.

"Children like my son might be dead without it," says Bridget Sediqzad, whose son, Maddox, was diagnosed with bipolar disorder at 3, when he was sleeping no more than a couple of hours at a time, throwing eight-hour-long tantrums, and biting other children at daycare.

Maddox also experienced hallucinations that caused him to jump out of a low-story window, leading to a recent diagnosis of schizo-affective disorder (combining traits of bipolar and schizophrenia). At age 7, Maddox's problems are managed by five different psychiatric medications; today he's a loving big brother to a new baby at home and can accompany his mom to the store for 15 minutes or so without a meltdown.

"For us, that's real progress," says Sediqzad.

"While we have to weigh the possible side effects of medications, we also have to consider the cost of not treating certain kids," says Louis Kraus, M.D., chief of child and adolescent psychiatry at Rush University Medical Center, in Chicago. "If a child can't remain in a regular class or is excluded from ordinary social experiences, that's not ideal. If medicine is the best option for a child, for a family, it should be considered."

"I Think We Found What She Needed"

What nearly everyone agrees on is that these medicines are not meant to be a quick solution for stressed-out families. If medication is suggested for a preschooler,

Dr. Gleason suggests parents find out if it's been tested in young children, and if not, how older kids do with it. Parents should learn about all the side effects of a possible medication before filling a prescription. Most important, parents should remember that they know their child best. Dr. Klein recommends that if parents are uncomfortable with a doctor's judgment, they should seek a second opinion.

"And remember, if you start your child on a treatment, don't think of it like jumping off a cliff. You can change course later. You are ultimately the one to decide whether to maintain a child's medication."

With medical help, Victoria was able to wean Shelby off several powerful medications. She's now on three drugs that seem to be controlling her symptoms without extreme side effects. Though Shelby still has tantrums and doesn't always get the sleep she needs, her outbursts are less frequent and she's more receptive to reason.

"I can say 'Grandma can't join us for lunch today because she has a doctor's appointment,' and she'll say 'Oh, okay,' rather than having a fit. That's huge for us," says Victoria.

She describes a recent trip to Target to pick out Halloween costumes: "Shelby wanted to be a butterfly, and I suggested that her sister be Dorothy. It was eight at night, and yet she was able to calmly explain that there were no butterflies in Oz, so we should pick something else for her sister. I realized that this is who Shelby is. The last two years have been a nightmare, but I think we found what she needed."