Low‑Dose Doxepin for Adult Sleep‑Maintenance Insomnia
Guideline Recommendation (American Academy of Sleep Medicine)
- The American Academy of Sleep Medicine (AASM) 2017 clinical practice guideline recommends low‑dose doxepin (3 mg or 6 mg) for treating sleep‑maintenance insomnia in adults compared with no treatment; this is a weak recommendation based on low‑quality evidence, with benefits judged to outweigh harms. 1, 2, 3, 4, 5, 6
Efficacy Outcomes (Evidence from AASM‑endorsed Trials)
- In adults with sleep‑maintenance insomnia, low‑dose doxepin increased total sleep time by a mean of 26–32 minutes versus placebo (95 % CI 18–40 min). 7
- The same population experienced a mean reduction in wake after sleep onset of 22–23 minutes compared with placebo (95 % CI 14–30 min). 7
- Sleep quality showed a small‑to‑moderate improvement relative to placebo. 7
Dosing Algorithm (AASM Guidance)
- Starting dose: 3 mg orally at bedtime. 1, 2, 3, 4
- Titration: If sleep‑maintenance remains inadequate, the dose may be increased to 6 mg. 1, 2, 3, 4
Indications and Contraindications (AASM Guidance)
- Indication: Low‑dose doxepin is indicated only for sleep‑maintenance insomnia; it is not recommended for sleep‑onset insomnia. 1, 2, 3, 4
- Alternative agents for sleep‑onset insomnia (when doxepin is unsuitable) include zaleplon, zolpidem, or ramelteon. 1, 2
Contextual Evidence from Other Guidelines
- The American College of Physicians (ACP) 2016 guideline reported insufficient evidence for the class of antidepressants in treating insomnia, a statement that predates the specific low‑dose doxepin trials. 8