Efficacy of Extended Melatonin on sleep cycle in patients with PD and RBD.


About this study

The primary aim of this study is to compare effectiveness of immediate versus extended-release melatonin as a supplement affecting the sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).  The secondary aim is to evaluate the superiority and effect of immediate and extended-release melatonin versus not taking any melatonin on sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).

Rapid eye movement (REM) sleep behavior disorder (RBD) is very common in patients with Parkinson disease and manifests with the loss of REM sleep atony, vigorous motor jerks, nocturnal vocalizations and dream enactment. Melatonin is commonly used as symptomatic management for RBD, but its efficacy is only supported by observational studies and a few controlled trials with relatively small number of participants. Melatonin may influence sleep cycle and affect clinical manifestations of RBD by decreasing muscle tonicity during REM sleep.  

Sleep normally cycles through REM and non-rapid eye movement (NREM) stages on average 4 to 6 times during the night. As the night progresses, fewer NREM stages occur, and the duration of REM sleep episodes increases. In a US-based randomized, crossover pharmacokinetic (PK) evaluation study,  an extended-release melatonin (ERM) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the immediate- release melatonin (IRM). We hypothesize that extended-release melatonin would be more helpful in regulating sleep cycle and affecting RBD, since REM density increases as night progresses. To our knowledge, no study that compares the efficacy of extended versus immediate-release melatonin on sleep cycle and its effect on RBD in patients with Parkinson disease has been done.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.

- Patient registered to Parkinson's disease database of Mayo Clinic Florida.

Exclusion Criteria:

- Patients who are using other sleep aids or medications (Clonazepam).

- Patients who are not willing to undertake 1 week of washout period.

- Patients who do not sign a consent for research.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/8/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Emir Festic, M.D., M.S.

Open for enrollment

Contact information:

Amra Sakusic M.D.


More information


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