Results of a new study show that doctors often prescribe medications to treat a child’s sleep problems. Many of these medications lack FDA approval for use in children.
The study looked at U.S. survey data from 1993 to 2004. The authors analyzed reports of patient visits to a doctor’s office. The study group involved children who were 17 years old or younger.
The researchers estimated that children visited a doctor for a sleep problem about 18.6 million times during the study period. Children were most likely to visit a pediatrician or psychiatrist. Forty-four percent of the office visits were in the southern region of the U.S.
Doctors prescribed a medication for 81 percent of these children (8 out of 10). The most common choice for treatment was an antihistamine. This was chosen 33 percent of the time. Drugs that treat high blood pressure were another common choice. These drugs cause sleepiness as a side effect. They were prescribed by doctors 26 percent of the time.
Doctors prescribed a drug that promotes sleep or reduces anxiety for sixteen percent of children. These drugs have not been approved for use in children. In six percent of cases doctors prescribed an antidepressant. Some antidepressants are approved for use in children. But they have not yet been approved to treat insomnia.
The study was published in the August 1 issue of the journal Sleep.
The researchers note that there is no FDA-approved medication for insomnia in children. According to the FDA, only 20 to 30 percent of all approved drugs are labeled for pediatric use. This is because very few drugs have been tested in children. The FDA cites two primary reasons for this lack of research: economics and logistics.
Testing a drug in children can be expensive. If only a small number of children are likely to use the drug, then the drug company has little incentive to invest in the needed research. Also, studying children can be more complicated than studying adults. It involves unique challenges.
With so few drugs approved for use in children, doctors often must decide which drug and dose are best. As a result it is common practice for a doctor to prescribe an approved drug for an unapproved use. This is known as an “off-label” prescription. Insomnia is only one of many conditions in children for which doctors often prescribe drugs off-label.
Choosing Another Option
Yet medications are only one treatment option for insomnia. Much of what people perceive as insomnia is related to their sleep habits and environment. Insomnia symptoms often improve when very simple changes are made to common behaviors. This treatment strategy is known as behavioral therapy.
Behavioral therapy is safe and is often effective at treating insomnia. Yet doctors prescribed it for only 22 percent of children in the study group. Some of these children were referred for psychotherapy. Stress management was prescribed for others. Doctors prescribed treatment with both a medication and behavioral therapy for 19 percent of children. Diet and nutrition counseling was prescribed for seven percent of children.
In 2003 a task force of sleep experts examined the use of medications to treat insomnia in children. The group was formed by the American Academy of Sleep Medicine. Its report was published in 2005 in the Journal of Clinical Sleep Medicine.
Included in the task force report were these conclusions:
- In almost all cases a medication is not the first treatment option for a child’s sleep problems.
- The first step in a treatment plan is to make sure that good sleep habits are practiced in the home.
- Treatment must be based on a careful clinical evaluation of the symptoms. All possible causes should be considered.
- A medication should always be used together with behavioral treatment methods.
- A medication should only be used on a short-term basis.
- A medication should be used with caution. The child must be monitored closely for possible side effects.
- A medication is rarely required for a sleep problem in an infant or very young child.
The task force also concluded that a child or teen should see a sleep specialist in these cases:
- The sleep problem is ongoing and severe. It does not respond to simple behavioral treatment. The problem is extremely disruptive.
- A parasomnia occurs along with symptoms of another problem that disrupts sleep. Parasomnias are common in children. They include nightmares, sleep terrors, confusional arousals and sleepwalking.
- Treatment with a medication is being considered.
- A related medical, psychiatric, or developmental problem creates other challenges.
- A circadian rhythm sleep disorder is present. One example is delayed sleep phase disorder. This is a common problem in teens.
The American Academy of Sleep Medicine accredits centers and labs that treat people who have sleep problems. AASM accreditation shows that a sleep center or lab maintains the highest standards in all it does.
There are more than 1,200 AASM-accredited centers and labs across the country. Visit www.sleepcenters.org to find an accredited sleep center or lab near you.
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Parasomnias — Tips for Parents
Teens & School Start Times
Behavioral Treatments are Effective for Childhood Bedtime Problems and Night Wakings
Accredited Sleep Disorders Centers
Reviewed by Rose Franco, MD
Updated August 10, 2007