What is the safest sleep aid?

Safest Sleep Aid for Adults

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the safest and most effective first-line treatment for insomnia, with superior long-term outcomes compared to any pharmacological option. 1

Non-Pharmacological Options (Safest)

• CBT-I should be the initial treatment intervention for chronic insomnia before considering any medication, as it has demonstrated superior long-term efficacy without the risks associated with pharmacotherapy 2, 1
• Brief Behavioral Treatment for Insomnia (BBT-I) focusing on behavioral components can also effectively treat insomnia with minimal risk 1
• Sleep hygiene education alone is not effective for treating chronic insomnia but should be used in combination with other therapies 1
• For hospitalized patients, non-pharmacological interventions like earplugs, eye masks, and noise/light reduction strategies can improve sleep quality with virtually no risk 3

Pharmacological Options (When Necessary)

First-Line Pharmacological Options

• Short/intermediate-acting benzodiazepine receptor agonists (BzRAs) like zolpidem or eszopiclone, or ramelteon are recommended as first-line pharmacological options when medication is necessary 2, 1
• These medications carry risks including complex sleep behaviors (sleep-driving, sleep-eating), morning drowsiness, and potential for dependence 4, 5
• Low-dose doxepin (3-6 mg) is recommended as a second-line option for sleep maintenance insomnia 1, 3

Not Recommended

• Over-the-counter antihistamines (like diphenhydramine or hydroxyzine) are not recommended due to lack of demonstrated efficacy and significant safety concerns including anticholinergic effects, daytime sedation, and increased risk of falls, especially in older adults 2, 1, 6
• Melatonin is not recommended by the American Academy of Sleep Medicine for treating chronic insomnia in adults due to insufficient evidence of efficacy 2
• Valerian, tryptophan, and other herbal/nutritional supplements are not recommended due to lack of demonstrated efficacy and limited safety data 2, 1

Melatonin Considerations

• While not recommended by clinical guidelines for chronic insomnia, melatonin has a relatively favorable safety profile compared to prescription sleep medications 7, 8
• Most reported adverse events with melatonin are mild, including daytime sleepiness (1.66%), headache (0.74%), dizziness (0.74%), and hypothermia (0.62%) 7
• Melatonin may be more appropriate for circadian rhythm sleep disorders than for primary insomnia 9, 10
• Effective doses typically range from 1-5 mg in adults, with limited evidence for higher doses 8
• There is insufficient evidence regarding long-term safety of melatonin use 7, 11

Special Populations

• For older adults (>55 years), prolonged-release melatonin may be considered as a first-line treatment for insomnia with fewer risks than prescription medications 2
• In children with autism spectrum disorders, melatonin has shown effectiveness for improving sleep with minimal adverse effects 2
• For patients with REM sleep behavior disorder, clonazepam is suggested to decrease sleep-related injury, though it should be used with caution in patients with dementia, gait disorders, or sleep apnea 2

Clinical Algorithm for Sleep Aid Selection

1. Begin with CBT-I or BBT-I for all patients with insomnia 2, 1
2. If pharmacotherapy is necessary:
   • For short-term use: Consider short/intermediate-acting BzRAs (zolpidem, eszopiclone) or ramelteon at lowest effective dose 2, 1
   • For patients >55 years: Consider prolonged-release melatonin 2
   • For patients with comorbid depression/anxiety: Consider low-dose sedating antidepressants (trazodone, doxepin) 2, 1
3. Avoid antihistamines, valerian, and other herbal supplements due to limited efficacy and safety concerns 2, 6
4. Monitor for adverse effects and reassess need for continued pharmacotherapy regularly 1