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

> **NCT06953869** · PHASE3 · RECRUITING · sponsor: **Vanda Pharmaceuticals** · enrollment: 420 (estimated)

## Conditions studied

- Insomnia Disorder

## Interventions

- **DRUG:** Tasimelteon Oral Suspension
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT06953869
- **Lead sponsor:** Vanda Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-04-21
- **Primary completion:** 2027-11
- **Final completion:** 2028-01
- **Target enrollment:** 420 (ESTIMATED)
- **Last updated:** 2025-05-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06953869

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06953869, "Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06953869. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*