From the Guidelines
Melatonin should not be used as a treatment for sleep onset or sleep maintenance insomnia in adults, including a 71-year-old male patient taking duloxetine (Cymbalta), according to the American Academy of Sleep Medicine clinical practice guideline 1. This recommendation is based on trials of 2 mg doses of melatonin. Instead, cognitive behavioral therapy for insomnia (CBT-I) is recommended as the initial treatment for chronic insomnia disorder, with pharmacological therapy considered only after CBT-I has been unsuccessful 1. When considering pharmacological therapy, the benefits, harms, and costs of short-term use of medications should be discussed with the patient using a shared decision-making approach 1. In this case, the patient's complex medication regimen, including duloxetine, should be reviewed by his healthcare provider or pharmacist to check for potential interactions with any new medications. Non-pharmacological approaches to improve sleep hygiene, such as maintaining a regular sleep schedule, avoiding caffeine and alcohol before bedtime, and creating a comfortable sleep environment, should also be implemented. Some alternative pharmacologic treatments, such as eszopiclone, zolpidem, or doxepin, may be considered, but their use should be carefully evaluated and monitored due to potential risks and side effects 1.
From the Research
Safety of Melatonin in a 71-year-old Male Patient
The patient is currently taking a complex medication regimen including Duloxetine (Cymbalta) and is requesting melatonin for sleep.
- The safety of melatonin in this patient population is supported by several studies, including a systematic review of 37 randomized controlled trials that found melatonin to be generally safe and well-tolerated, with few adverse events (AEs) reported 2.
- Another study found that higher doses of melatonin (≥10 mg) were also safe in adults, with no significant increase in serious adverse events (SAEs) or withdrawals due to AEs 3.
- However, it is essential to consider the potential interactions between melatonin and the patient's current medications, including Duloxetine, which is a mixed serotonin and norepinephrine reuptake inhibitor (SNRI) 4.
- A study on the treatment of circadian rhythm disorders with melatonin found that it can have both acute and delayed effects on sleep and circadian rhythms, but its long-term safety data are limited 5.
- A recent review on the chronic administration of melatonin found that it appears to be safe at low to moderate dosages (approximately 5-6 mg daily or less), but its long-term effects have been insufficiently studied and warrant additional investigation 6.
Potential Interactions with Duloxetine
- There is limited information available on the potential interactions between melatonin and Duloxetine.
- However, considering the patient's complex medication regimen, it is crucial to monitor for potential adverse events, such as increased risk of serotonin syndrome or other interactions 4.
Recommendations
- Before prescribing melatonin to this patient, it is essential to weigh the potential benefits against the potential risks and consider alternative treatments for sleep disorders.
- If melatonin is prescribed, it is crucial to monitor the patient closely for adverse events and adjust the dosage or discontinue treatment as needed.
- Further research is needed to fully understand the safety and efficacy of melatonin in this patient population, particularly in relation to its interactions with other medications like Duloxetine 2, 3, 6.