Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

• Tasimelteon Oral Suspension (Drug): Single daily dose, weight-based liquid suspension formulation.
• Placebo (Drug): Placebo comparator.

Primary outcomes

• Change in sleep latency, as measured by daily sleep diary. [12 Weeks]

Secondary outcomes

• Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary. [12 Weeks]
• Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary. [12 Weeks]
• Change in daytime functioning, as measured by questionnaire. [12 Weeks]
• Change in behavior, as measured by questionnaire. [12 Weeks]
• Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy. [12 Weeks]
• Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [12 Weeks]

Sex: All, ages: 2 Years to 17 Years

Inclusion Criteria:

* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
* Confirmed clinical diagnosis of insomnia disorder
* Males and Females between 2 and 17 years, inclusive.
* The sleep disturbance must not be a result of another medication.

Exclusion Criteria:

* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
* Indication of impaired liver function.
* Pregnant or lactating females.
* A positive test for drugs of abuse.