Can doxepin (tricyclic antidepressant) be used for sleep maintenance in youngsters and what is the recommended dose?

Use of Doxepin for Sleep Maintenance in Youngsters

Doxepin is not recommended for sleep maintenance in children and adolescents due to lack of FDA approval and limited safety data in this population. While low-dose doxepin (3-6 mg) is suggested for treating sleep maintenance insomnia in adults, there are no established guidelines supporting its use in pediatric patients.

Evidence for Adult Use

• Doxepin at low doses (3 mg and 6 mg) is recommended by the American Academy of Sleep Medicine for treating sleep maintenance insomnia in adults 1

• In adults, doxepin shows clinically significant improvements in:

  • Wake after sleep onset (WASO) - mean reduction of 22-23 minutes compared to placebo 1
  • Total sleep time (TST) - mean improvement of 26-32 minutes compared to placebo 1
  • Sleep efficiency (SE) 1

• The efficacy for sleep maintenance is attributed to doxepin's selective histamine H1 receptor antagonism at low doses 2, 3

Pediatric Considerations

• There are currently no FDA-approved medications for pediatric insomnia when first-line therapies fail 4
• Clinical practice guidelines for insomnia pharmacotherapy focus exclusively on adult populations 1
• Limited research exists on doxepin use in children and adolescents:
  • A single-center retrospective chart review found that low-dose doxepin showed some efficacy in pediatric patients whose sleep failed to improve with behavioral intervention and melatonin 4
  • In this limited study, treatment was initiated at a median starting dose of 2 mg and slowly escalated to a median maintenance dose of 10 mg 4
  • However, this represents low-quality evidence from a single retrospective study

Safety Concerns

• Safety data for doxepin in pediatric populations is extremely limited 4
• Potential adverse effects observed in adults include:
  • Somnolence (particularly at 6 mg doses) 1, 5
  • Headache 1, 5
  • In the limited pediatric study, adverse effects included behavioral side effects (aggression) and enuresis in 6.9% of patients 4

Treatment Algorithm for Pediatric Insomnia

1. First-line approaches should always include:

   • Behavioral interventions 4
   • Sleep hygiene education (though not effective alone) 1

2. If first-line approaches fail, melatonin may be considered before any prescription medications 4

3. For pharmacological management when other approaches fail:

   • The VA/DoD clinical practice guidelines suggest considering low-dose doxepin (3 or 6 mg) for adults with chronic insomnia disorder who are unable or unwilling to receive cognitive behavioral therapy 1
   • However, these recommendations do not extend to pediatric populations

Conclusion

Based on the available evidence, doxepin cannot be recommended for routine use in children and adolescents with sleep maintenance insomnia due to:

• Lack of FDA approval for pediatric use
• Absence of clinical practice guidelines supporting pediatric use
• Limited safety and efficacy data in this population

If considering off-label use in treatment-resistant cases, consultation with a pediatric sleep specialist is strongly advised, with careful monitoring for adverse effects.