What if melatonin (melatonin) isn't effective for treating insomnia?

When Melatonin Isn't Working for Insomnia: Alternative Treatment Approaches

If melatonin isn't effective for treating insomnia, cognitive behavioral therapy for insomnia (CBT-I) should be considered as the first-line treatment, followed by prescription sleep medications if necessary, as melatonin has insufficient evidence for efficacy in chronic insomnia. 1

First-Line Approach: Cognitive Behavioral Therapy for Insomnia (CBT-I)

The American College of Physicians strongly recommends CBT-I as the initial treatment for chronic insomnia based on moderate-quality evidence 1:

• CBT-I is effective in treating both the general adult population and older adults with chronic insomnia
• It's noninvasive with fewer potential harms compared to pharmacologic treatments
• It provides better overall value than pharmacologic treatment
• It can be performed and prescribed in the primary care setting

Second-Line Approach: Pharmacologic Options

If CBT-I alone is unsuccessful, consider adding pharmacologic therapy through shared decision-making 1:

FDA-Approved Medications with Evidence of Efficacy:

• Eszopiclone: Low-quality evidence shows improvement in global outcomes and sleep parameters 1
• Zolpidem: Low-to-moderate quality evidence shows improvement in sleep onset latency and other sleep parameters 1
• Doxepin: Low-to-moderate quality evidence shows improvement in ISI scores and sleep outcomes 1
• Suvorexant: Moderate-quality evidence shows improved treatment response and sleep outcomes 1
• Ramelteon: Low-quality evidence shows decreased sleep onset latency in older adults 1, 2

Important Cautions with Pharmacologic Therapy:

• FDA has approved these medications only for short-term use (4-5 weeks) 1
• Patients should be discouraged from using these drugs for extended periods 1
• Observational studies show hypnotic drugs may be associated with serious adverse effects including dementia, injury, and fractures 1
• FDA labels warn of daytime impairment, "sleep driving," behavioral abnormalities, and worsening depression 1

Why Melatonin May Not Be Working

Several factors explain melatonin's limited efficacy for chronic insomnia:

• Evidence is insufficient to determine the effectiveness of melatonin on global or sleep outcomes in both general population and older adults 1
• Studies evaluating melatonin have yielded inconsistent results 1
• Melatonin's short half-life and typically small doses used may contribute to its limited effectiveness 3
• Higher doses (50-100mg/day) may be needed for efficacy, but most studies use only 2-3mg/day 3

Non-Pharmacological Approaches to Try

Before or alongside pharmacologic options, consider these evidence-based approaches:

• Light therapy: Increase duration and intensity of light exposure during daytime and avoid bright light in the evening 1
• Structured physical and social activity: Helps provide temporal cues needed to increase sleep-wake schedule regularity 1
• Sleep environment optimization: Reduce nighttime light and noise 1
• Multidimensional approach: Combine increased sunlight exposure, social activity during the day, decreased time in bed during the day, and decreased nighttime noise 1

Special Considerations for Specific Populations

Older Adults (≥55 years):

• Prolonged-release melatonin may be more effective in this population 2, 4
• Shows improvement in quality of sleep and morning alertness without withdrawal effects 4

Cancer Patients:

• Melatonin may improve sleep quality and insomnia, though evidence is mixed 5
• Doses ranging from 3-20mg have been studied 5

When to Re-evaluate Treatment

If insomnia does not remit within 7-10 days of treatment, further evaluation is recommended by the FDA 1