Published online June 1, 2006
PEDIATRICS Vol. 117 No. 6 June 2006, pp. e1223-e1232 (doi:10.1542/peds.2005-1693)
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SPECIAL ARTICLE

Pharmacologic Management of Insomnia in Children and Adolescents: Consensus Statement

Jodi A. Mindell, PhDa, Graham Emslie, MDb, Jeffrey Blumer, MD, PhDc, Myron Genel, MDd, Daniel Glaze, MDe, Anna Ivanenko, MD, PhDf, Kyle Johnson, MDg, Carol Rosen, MDc, Frank Steinberg, DOh, Thomas Roth, PhDi and Bridget Banasj

a Department of Psychology, Saint Joseph's University and Sleep Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
b Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
c Department of Pediatrics, School of Medicine, Case Western Reserve University, Cleveland, Ohio
d Child Health Research Center, Department of Pediatrics, School of Medicine, Yale University, New Haven, Connecticut
e Departments of Pediatrics and Neurology, Baylor College of Medicine, Houston, Texas
f Departments of Psychiatry and Neurosciences, Loyola University Medical Center, Chicago, Illinois
g Departments of Psychiatry and Pediatrics, Oregon Health and Science University, Portland, Oregon
h Medical Consultant, Evanston, Illinois
i Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, Michigan
j Medical Writer, Boston, Massachusetts

OBJECTIVE. The purpose of this work was to develop a consensus statement on the current status and future role for pharmacologic management of insomnia in children and adolescents.

METHOD. The National Sleep Foundation, in collaboration with Best Practice Project Management, Inc, convened expert representatives involved in the study and treatment of pediatric insomnia and conducted a 2-day conference to examine the role of pharmacologic management of pediatric insomnia and to make recommendations regarding the development of clinical trials in this area. After a series of presentations providing background on the current knowledge of pediatric insomnia and its treatment alternatives, workgroups provided recommendations for the evaluation of pharmacologic treatment of insomnia in specific populations of children and adolescents and developed guidelines for the core methodologic issues relevant to the design of clinical trials. The group developed consensus recommendations for clinical trials in this area encompassing: (1) high-priority patient populations for research, (2) inclusion/exclusion criteria, (3) outcome measures, (4) ethical considerations unique to clinical trials involving children and adolescents, and (5) priorities for future research that will enhance the understanding of pediatric insomnia.

RESULTS. Conference participants unanimously agreed that there is a need for pharmacologic management of pediatric insomnia. Furthermore, the widespread use of "hypnotic" and psychotropic medications for children in the absence of safety and efficacy data indicates a knowledge gap about the best pharmacologic practices for management of pediatric insomnia. Attendees reached consensus on methodologic issues in the study of pharmacologic treatment of pediatric insomnia including agreeing on a definition of pediatric insomnia as "repeated difficulty with sleep initiation, duration, consolidation, or quality that occurs despite age-appropriate time and opportunity for sleep and results in daytime functional impairment for the child and/or family." It was agreed that priority should be given to insomnia studies in children with attention-deficit/hyperactivity disorder and those with pervasive developmental disorders/autism spectrum disorder. There was also agreement on the need for pharmacokinetic and pharmacodynamic studies to determine appropriate dose levels and to evaluate safety with a wide range of doses.

CONCLUSIONS. The treatment of pediatric insomnia is an unmet medical need. Before appropriate pharmacologic management guidelines can be developed, rigorous, large-scale clinical trials of pediatric insomnia treatment are vitally needed to provide information to the clinician on the safety and efficacy of prescription and over-the-counter agents for the management of pediatric insomnia.

Key Words: insomnia • clinical trials • pediatric • pharmacotherapy • sleep disorders

Abbreviations: ADHD—attention-deficit/hyperactivity disorder • PDD—pervasive developmental disorder • MDD—major depressive disorder • DSPS—delayed sleep phase syndrome • PSG—polysomnography

Accepted Jan 23, 2006.




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