Effects of Melatonin on Insomnia Symptoms in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230737
Recruitment Status : Completed
First Posted : October 3, 2005
Results First Posted : March 8, 2017
Last Update Posted : March 8, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Nalaka Gooneratne, University of Pennsylvania

September 12, 2005
October 3, 2005
January 17, 2017
March 8, 2017
March 8, 2017
October 2004
May 2008   (Final data collection date for primary outcome measure)
Peak Melatonin Level [ Time Frame: day 42 ]
Pharmacokinetic analysis of maximum melatonin level
  • Sleep efficiency (subjective and objective)
  • neurobehavioral assessment battery
Complete list of historical versions of study NCT00230737 on Archive Site
Not Provided
  • psychomotor vigilance testing
  • functional outcomes of sleepiness questionnaire
Not Provided
Not Provided
Effects of Melatonin on Insomnia Symptoms in Older Adults
Melatonin Randomized Trial for Insomnia in the Elderly
This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.

Melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. Melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. Clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia, regardless of their endogenous melatonin levels. Data indicate, however, that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin. Generally, melatonin levels decrease with age; therefore, older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep. This study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep.

Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints, the beginning of Week 1 and the end of Week 6. At study entry, participants will be admitted to the General Clinical Research Center for a 3-night stay, beginning with an overnight urine screen to confirm low melatonin levels. Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity; the diary will be used throughout the study. During Night 1 at the clinic, participants will have urine samples collected throughout the night. Night 2 will be an adaptation night to allow participants to get used to their surroundings. On Night 3, participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency. Participants with sleep efficiencies of 80% or higher will complete their study participation. Participants with sleep efficiencies less than 80% will be randomly assigned to one of three study treatments daily for 6 weeks: high-dose melatonin (4.0 mg), low-dose melatonin (0.4 mg), or placebo. Participants will have study visits at Weeks 1, 3, and 6 to monitor for adverse events. After 6 weeks, participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study. Sleep questionnaires, cognitive tests, and psychomotor tests will be used to assess participants at the beginning of the study, after 6 weeks, and at the end of the study. One month after the end of the study, participants will have a follow-up visit to be reassessed for adverse events.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: Melatonin 0.4 mg
  • Drug: Melatonin 4.0 mg
  • Drug: Placebo
  • Experimental: A
    Melatonin 0.4 mg
    Intervention: Drug: Melatonin 0.4 mg
  • Experimental: B
    Melatonin 4.0 mg
    Intervention: Drug: Melatonin 4.0 mg
  • Placebo Comparator: C
    Intervention: Drug: Placebo
Gooneratne NS, Edwards AY, Zhou C, Cuellar N, Grandner MA, Barrett JS. Melatonin pharmacokinetics following two different oral surge-sustained release doses in older adults. J Pineal Res. 2012 May;52(4):437-45. doi: 10.1111/j.1600-079X.2011.00958.x. Epub 2012 Feb 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01AT001521-01A1( U.S. NIH Grant/Contract )
R01AT001521-01A1 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Nalaka Gooneratne, University of Pennsylvania
Nalaka Gooneratne
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Nalaka S. Gooneratne, MD,MSc University of Pennsylvania
University of Pennsylvania
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP