What are the most effective over-the-counter (OTC) sleep aids?

Most Effective Over-the-Counter Sleep Aids

Based on current evidence, over-the-counter sleep aids are generally not recommended for treating insomnia, as they have limited efficacy and potential safety concerns. 1

Evaluation of Common OTC Sleep Aids

Antihistamines (Diphenhydramine and Doxylamine)

• Diphenhydramine (Benadryl, Unisom SleepGels): The American Academy of Sleep Medicine explicitly recommends against using diphenhydramine for sleep onset and maintenance insomnia 1
• Doxylamine (Unisom SleepTabs): While marketed as a "clinically tested, proven effective" nighttime sleep aid 2, there is insufficient evidence supporting its efficacy over placebo
• Safety concerns:
  • Particularly problematic for older adults (≥65 years) - listed in the Beers Criteria as potentially inappropriate 3
  • Common side effects include daytime sleepiness, dizziness, dry mouth, and cognitive impairment
  • A study found that 59% of older adults using OTC sleep aids were taking potentially inappropriate products containing diphenhydramine or doxylamine 3

Melatonin

• Efficacy: The American Academy of Sleep Medicine recommends against using melatonin for treating insomnia 1
• Formulation: Available as dietary supplement in various doses (commonly 3mg) 4
• Evidence:
  • Limited efficacy for primary insomnia
  • May be more effective for specific conditions like jet lag 5
  • Prolonged-release formulations show more consistent benefits in older adults with diagnosed insomnia compared to immediate-release formulations 6
• Safety: Generally well-tolerated with mild adverse effects including daytime sleepiness (1.66%), headache (0.74%), dizziness (0.74%), and hypothermia (0.62%) 7

Valerian

• Efficacy: The American Academy of Sleep Medicine recommends against using valerian for sleep onset or maintenance insomnia 1
• Evidence: Clinical trials show limited beneficial effects on sleep measures 6

L-Tryptophan

• Efficacy: The American Academy of Sleep Medicine recommends against using tryptophan for sleep onset or maintenance insomnia 1

Special Considerations for Different Populations

Older Adults

• Antihistamines (diphenhydramine and doxylamine) should be avoided due to anticholinergic effects and increased risk of confusion, urinary retention, and falls 3
• Melatonin may be safer than antihistamines in older adults but still shows limited efficacy 8

Children

• For children with sleep disorders, behavioral interventions and sleep hygiene should be first-line treatment 9
• If pharmacological intervention is needed, melatonin may be considered at 3mg of immediate-release 30-60 minutes before bedtime, titrated up to 5mg if needed 9

Recommendations for Improving Sleep

1. Prioritize sleep hygiene measures:

   • Consistent sleep-wake schedule
   • Regular exercise (morning or afternoon)
   • Limit screen time before bed
   • Create a calm, quiet, dark sleep environment
   • Avoid caffeine, alcohol, and large meals before bedtime

2. If an OTC sleep aid is necessary:

   • Melatonin may be the safest option with fewest side effects, though efficacy is limited
   • Start with lowest effective dose
   • Use for short-term only
   • Consider prolonged-release formulations, especially for older adults

3. When to seek professional help:

   • Persistent insomnia despite good sleep hygiene
   • Symptoms of underlying sleep disorders (sleep apnea, restless legs)
   • Significant daytime impairment

Pitfalls to Avoid

• Long-term use of OTC sleep aids without medical supervision
• Assuming OTC means completely safe
• Using antihistamines as sleep aids in older adults
• Ignoring underlying causes of sleep disturbances
• Self-medicating chronic insomnia instead of seeking professional evaluation