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Oral and transdermal melatonin treatment to improve insufficient sleep in youth at risk for mental health disorders

Award Number: R15HL179371
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Oral and transdermal melatonin treatment to improve insufficient sleep in youth at risk for mental health disorders - Abstract Sleep problems in childhood and adolescence are independent risk factors for anxiety and depression. Melatonin may improve mental health by promoting sleep or improving autonomic nervous system balance. In addition to oral supplements, melatonin can be purchased in the form of lotion which may have a much longer half-life in the body. Using salivary sampling over 48 hours, this project will characterize the time course of the absorption and metabolism of lotionbased melatonin and whether more side effects occur than found with oral administration. In a randomized crossover design, 14 – 21 year olds at risk for mental health problems will then be assigned to a 7-day treatment arm of melatonin lotion, oral supplements, and placebo controls. Impacts on sleep, autonomic nervous system indicators, mood, anxiety symptoms, and side effects will be assessed. Sleep will be measured using wrist-worn activity trackers and participant diaries. Autonomic nervous system balance will be measured using heart rate variability and salivary alpha-amylase, and adherence to the protocol will be confirmed via salivary melatonin. Anxiety symptoms, mood, and side effects will be assessed using daily questionnaires. To probe possible mechanisms, changes in sleep and nervous system parameters will be examined for correlations to any improvements in anxiety and depression symptoms. Our study can determine whether melatonin is an effective treatment for adolescents with inadequate sleep, and whether sleep improvements or autonomic activity are potential links to improvements in depression and anxiety symptoms.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $474,780 )
2026	2026	UNIVERSITY OF REDLANDS	1200 E COLTON AVE	REDLANDS	CA	92374	SAN BERNARDINO	USA	National Center on Sleep Disorders Research	000	1	9/1/2026	NEW	$474,780
2026	2026	UNIVERSITY OF REDLANDS	1200 E COLTON AVE	REDLANDS	CA	92374	SAN BERNARDINO	USA	National Center on Sleep Disorders Research	001	1	9/4/2026	NEW	$0
														Subtotal = $474,780

Grand Total All Awards = $474,780

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Oral and transdermal melatonin treatment to improve insufficient sleep in youth at risk for mental health disorders

Award Number: R15HL179371

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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