Phase 2
Completed N=27
Effects of Melatonin on Insomnia Symptoms in Older Adults
Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00230737 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Peak Melatonin Level — 405; 3999; 52 pg/ml — p=<0.001
Summary
This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Melatonin Level |
405; 3999; 52 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- History of insomnia
- Low melatonin levels at study entry
Exclusion Criteria
- History of sleep apnea (temporary cessation of breathing during sleep)
- Diagnosis of restless legs syndrome
- Current alcohol or substance abuse
- Dementia
- Anemia
- Liver disease
- Leukemia or lymphoma
- Asthma
Data sourced from ClinicalTrials.gov (NCT00230737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.