Small moleculeSleep & insomnia
- Primary research area
- Sleep · insomnia
- Regulatory status
- See formulation-specific sources
- Evidence level
- Human randomized trials
- Primary mechanism
- Low-dose sleep medicine
Reference profile available · Coverage varies by sectionAlso known as Silenor
What has been observed?
Selected source-linked reading notes, not the complete literature or a pooled conclusion.
Human · Abstract reviewedDoxepin: what did the insomnia trial show?
240 older adults with chronic primary insomnia were randomized to doxepin 1 mg (77), 3 mg (82), or placebo (81) nightly for 12 weeks.
The 3 mg dose improved the primary first-night wake-time-after-sleep-onset endpoint; sleep-maintenance benefits remained at night 85. Some outcomes also improved with 1 mg. Safety profiles were comparable, with no significant next-day residual effects detected.
Limits & adverse findings: This is a selected trial summary, not a full literature review or formal quality appraisal. Older adults with primary insomnia, followed for 12 weeks. Results do not establish safety of higher doses or exclude uncommon adverse events.
Open primary source · Read interpretation separatelyExplore outcomes for this compound- Uses & research
240 older adults with chronic primary insomnia were randomized to doxepin 1 mg (77), 3 mg (82), or placebo (81) nightly for 12 weeks. [1]
- Known half-life
No source-verified value in this profile yet. A treatment schedule or duration of an effect is not a drug half-life.
Half-life describes how quickly the measured drug concentration falls by half. It does not set a dosing interval.- Evidence & important limits
Older adults with primary insomnia, followed for 12 weeks. Results do not establish safety of higher doses or exclude uncommon adverse events. [1]
Safety & evidence boundaries
Source-specific information, not a personal safety clearance or monitoring plan.
Older adults with primary insomnia, followed for 12 weeks. Results do not establish safety of higher doses or exclude uncommon adverse events.
Human study: Older adults with primary insomnia, followed for 12 weeks. Results do not establish safety of higher doses or exclude uncommon adverse events. Source
Explore safety questions by system
These are literature filters, not claims that this compound causes each effect. A keyword match is not a confirmed adverse reaction.
Interactions, rare harms, long-term effects and reversibility require separate evidence. Do not infer they are absent when the sources here do not address them.
Identity, names & formulations
Canonical compound: Doxepin · doxepin
Searchable names: Silenor
Names share a parent research page. Different esters, salts, routes and brands are not assumed to have the same half-life, indication or exposure.
Combination evidence stays attached to the studied combination. It is not automatically assigned to each ingredient.
Understand the evidence types
Read the model and design first, then the population, outcome and limitations. These categories describe evidence, not a best-compound ranking.
- Randomized human trials
- Compare assigned interventions. Randomization does not by itself establish low bias or relevance to every population.
- Controlled human studies
- Use a comparison group; allocation and confounding still matter.
- Prospective human research
- Follows participants forward. It may be observational or interventional, so this is not a separate quality grade.
- Observational human research
- Describes associations. Confounding can explain differences.
- Case reports and series
- Useful for unusual events and safety signals, not reliable rates or effect sizes.
- Animal research
- Can test biology and function in a living model. Human exposure, benefit and safety remain separate questions.
- Cell and tissue research
- Tests responses in a preparation, including human-derived cells. It is not a human participant trial.
- Mechanistic and computational evidence
- Helps explain or predict a pathway; predictions need experimental and clinical testing.
- Anecdotal reports
- Self-reported experiences can generate questions. Product identity, selection bias and other interventions may be uncontrolled.
Systematic reviews synthesize studies and depend on their quality. Preprint status and abstract versus full-paper reading are separate labels. Citation popularity measures attention, not reliability. A study summary is not a formal quality appraisal.