Distributed May 5, 2003
For Immediate Release

News Service Contact: Kristen Cole

Use of medication to treat pediatric insomnia is common, study finds

Although guidelines do not exist for the use of medication to treat pediatric sleep disorders, about 75 percent of pediatricians surveyed had recommended some type of medication for that purpose within the previous six months. Pediatric sleep disturbances are among the most common and challenging complaints, and a set of clinical experience-based guidelines needs to be developed, according to a study in the May Pediatrics.

PROVIDENCE, R.I. — Despite a dearth of information about the use of medication for treating pediatric sleep disorders, about 75 percent of community-based pediatricians in a recent survey had recommended nonprescription medication, and more than 50 percent had prescribed a sleep medication to patients with difficulties falling and staying asleep.

Sleep disturbances in infants, children and adolescents are among the most common and challenging complaints in pediatric practice. Although studies have examined the effectiveness of behavioral treatments for sleep disorders, pharmacologic treatment is a poorly researched area. There are currently no medications labeled for use for sleep disturbances in children by the U.S. Food and Drug Administration, according to authors of a new study in the May issue of Pediatrics.

“While many pediatricians perceive a need for medications in selected cases, they generally lack confidence in the currently available medication options,” said Judith A. Owens, associate professor of pediatrics at the Brown Medical School and the study leader. “The pediatricians in our study expressed many reservations, particularly given the absence of clinical guidelines for the use of these drugs in children.”

Researchers surveyed 671 primary-care pediatricians in six U.S. cities during a two-month period in 2001. Pediatricians were asked when, what and why they had prescribed medication for children with difficulties in initiating or maintaining sleep during the previous six months, and about their beliefs and attitudes regarding the use of both nonprescription and prescription medications.

Overall, the practitioners appeared to be conservative in their approach to the use of these drugs and expressed concern about a variety of potential negative effects, according to the researchers.

The use of both prescription and nonprescription medications for pediatric insomnia seemed to fall into two general patterns: short-term situational use of non-prescription medications – such as for travel, acute pain or stress and longer-term, more chronic use of prescription drugs in children with special needs, including mental retardation, attention-deficit/hyperactivity disorder (ADHD) and autism.

The relationship between sleep problems in ADHD and the use of medication was particularly striking to the researchers. Insomnia in children with ADHD appeared to be a major contributor to the use of hypnotics or sedatives in clinical practice. The likelihood of prescribing medication for sleep was two-times greater in respondents who treated children with ADHD for daytime behavioral problems and four-times greater for nighttime sleep problems.

Additionally, the pediatricians surveyed clearly perceived that stress on families resulting from significant sleep disturbances in a child, particularly in families of special needs children, was a legitimate rationale for the use of sleep medications. At the same time, they tended to endorse the use of these medications only in combination with behavioral therapy or when other treatment had failed, according to the researchers.

The number of children with significant sleep problems seen in a six-month period was greatest in the infant and toddler group and decreased with age. Over-the-counter antihistamines were the most commonly recommended of all medications in all age groups and alpha-agonists were the most frequently prescribed sleep medications. Melatonin or herbal remedies had been recommended by about 15 percent of the respondents.

Previous studies of sleep disorders have documented high levels of sleep disorders in children including difficulty settling and frequent night wakings in up to 40 percent of infants; bedtime resistance, delayed sleep onset, and disruptive night wakings in 25 to 50 percent of preschoolers; and bedtime resistance in school-age children ranging from 15 to 27 percent.

A potential limitation of the study was the use of a retrospective survey format that required pediatricians to recall what they had done in the last six months, which may have limited accuracy and introduced some response bias.

Owens led the study with Carol L. Rosen, M.D., of Case Western Reserve University, and Jodi A. Mindell, of Saint Joseph’s University. The study was supported by an unrestricted educational grant from Sanofi-Synthelabo, and a grant to Owens from the National Institutes of Health.