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Efficacy and Tolerability of Ultra-Low-Dose Mirtazapine in Adult Chronic Insomnia

Rony Berbara1,2, Kamal Gandotra3,4,5,6, Elizabeth Zink7

  • 1Department of Sleep Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.

The Primary Care Companion for CNS Disorders
|March 20, 2026
PubMed

Insights

Ultra-low-dose mirtazapine (3.75 mg) significantly improved chronic insomnia symptoms in veterans. Most patients experienced reduced insomnia severity without reported next-day side effects, indicating a potential therapeutic benefit.

Area of Science:

  • Psychiatry
  • Pharmacology
  • Sleep Medicine

Background:

  • Insomnia is a prevalent sleep disorder affecting quality of life.
  • Mirtazapine is an antidepressant with sedative properties, typically used at higher doses.
  • Ultra-low-dose mirtazapine is being explored for insomnia treatment to minimize side effects.

Purpose of the Study:

  • To assess the efficacy of ultra-low-dose mirtazapine (3.75 mg) in improving insomnia.
  • To determine if this low dose causes next-day adverse effects.

Main Methods:

  • Retrospective analysis of outpatient data from veterans with insomnia.
  • Insomnia Severity Index (ISI) scores were collected at baseline and during follow-up visits.
  • Statistical comparison of ISI scores before and after 1-3 months of treatment.

Main Results:

  • 47% of veterans showed a clinically significant reduction in ISI scores (over 7 points).
  • Patients completing treatment maintained or improved their ISI scores.
  • Mean ISI score change in completers was -11.3 (SD 6.46).

Conclusions:

  • Ultra-low-dose mirtazapine (3.75 mg) appears effective in managing chronic insomnia symptoms.
  • This dosage may offer a viable treatment option for insomnia with a favorable side effect profile.

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