Conditions: Insomnia
Keywords: Sleep Initiation and Maintenance Disorders Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.

Detailed description:
Ramelteon is a treatment for insomnia approved for use in the United States (US) in July 2005 and in the Philippines and Indonesia in 2008. It is currently under development in the European Union (EU) and Japan. Ramelteon is marketed in the US as ROZEREM® for the treatment of insomnia characterized by difficulty with sleep onset in patients over 18 years of age.

In adolescents, the form of sleep onset and/or sleep maintenance insomnia, defined as psychophysiologic insomnia, is similar to adults, and more appropriate for treatment with pharmacological intervention when compared to insomnia in children younger than 12 years of age. In psychophysiologic insomnia, the individual develops conditioned anxiety around difficulty falling or staying asleep, which leads to heightened physiologic and emotional arousal and further compromises the ability to sleep. In children over the age of 12, insomnia is more likely to be persistent and have identifiable consequences. In addition, there is less variability in normative sleep data for this age group than in younger children.

Sleep disturbances are also common in children. Specifically, insomnia associated with ADHD in children is very common with a reported prevalence of 28% in medication-free children with ADHD.

This study is to characterize the pharmacokinetics (PK) and safety profile of a 4 or 8 mg dose of ramelteon in adolescents who are between 12 to 17 years of age (prior to the 18th birthday) with insomnia characterized by difficulty with sleep initiation, and in pediatrics who are between 6 to 11 years of age who have insomnia associated with ADHD. These profiles will be compared with those of healthy adults aged 18 to 50 years who are matched by race and gender receiving an 8 mg dose of ramelteon. This open-label study is designed in accordance with the recommendations of the FDA and ICH guidances for pediatric PK studies.

Arms:
arm 1: Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. arm 2: Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. arm 3: Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. arm 4: Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. arm 5: Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.

Interventions: intervention 1: Ramelteon
Intervention descriptions: intervention 1: Ramelteon tablets, orally for one day only.

Protocol document: