Delirium Reduction With Ramelteon (DREAM)

  • End date
    Dec 4, 2025
  • participants needed
  • sponsor
    Centennial Medical Center
Updated on 4 April 2023


The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.


Melatonin is an endogenous hormone that regulates the sleep-wake cycle along with several other physiological functions. It is reported that melatonin secretion may be impaired in ICU patients, and there is some question whether this may be a contributing factor to delirium occurrence. Ramelteon is a melatonin agonist with three to six times increased affinity for MT1 and MT2 receptors versus melatonin. It is FDA approved for the treatment of insomnia, and some studies suggested some benefit with ramelteon for delirium prevention. There is limited prospective research data assessing the efficacy of ramelteon for delirium treatment. The goal of this study therefore is to assess the efficacy of ramelteon versus placebo on the prevention and treatment of delirium in ICU patients.

Condition Delirium
Treatment Ramelteon 8mg
Clinical Study IdentifierNCT05069428
SponsorCentennial Medical Center
Last Modified on4 April 2023


Yes No Not Sure

Inclusion Criteria

Medical or surgical ICU patient
Ability to take oral or nasogastric tube within 48 hours of admission to ICU
Expected ICU length of stay and life expectancy at least 48 hours
Patient or POA capable of signing informed consent within 48 hours of ICU admission

Exclusion Criteria

Past medical history includes cirrhosis
Active alcohol withdrawal
Patients taking fluvoxamine prior to admission
Self-reported hypersensitivity to ramelteon
Incarcerated patients
Pregnant patients
Patients with acute neurological conditions including brain abscess, head bleed, meningitis
Patients who are transferred from an outside hospital where they have resided for greater than 4 days
Non-English speaking patients
Hearing-impaired patients requiring sign language for communication
Visually-impaired patients
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