| OTC dietary supplement (U.S.; not FDA-approved as a drug). Used for sleep-onset insomnia and circadian rhythm complaints (practice pattern). View labelExact | OTC products are product-dependent; many labels recommend one dose about 30 minutes before bedtime. | Endogenous sleep-wake hormone; MT1/MT2 receptor agonist. Widely used as an OTC dietary supplement for sleep-onset and circadian rhythm complaints. | CYP1A2, CYP2C19 | Single-dose range 1–2 h | No | | - Daytime sleepiness, dizziness, and next-day impairment (driving safety).
- Timing consistency and product quality (avoid stacking multiple melatonin products).
- Mood and sleep trajectories in depression or bipolar disorder.
- Reassess benefit after 1–2 weeks; discontinue if minimal benefit.
| No | 2025-12-30 |
|---|
| Insomnia (label). View labelExact | Take 8 mg within 30 minutes of bedtime (label). | Melatonin receptor agonist (MT1/MT2); hypnotic for sleep onset insomnia. | CYP1A2, CYP3A4, CYP2C9 | Single-dose mean 1.5 h; Single-dose range 1–2.6 h | No | | - Reassess sleep latency and next-day functioning within a few weeks; stop if benefit is minimal rather than escalating.
- Review interacting medications (especially CYP1A2 inhibitors/inducers) and timing with meals when response changes.
- Monitor mood and suicidality in patients with depression or mood instability when insomnia is part of a mood episode.
- Reinforce CBT-I and sleep hygiene and address sleep apnea/substance use when insomnia persists.
| No | 2026-03-31 |
|---|
| OTC sleep aid (product-dependent). Also used in combination with pyridoxine for nausea/vomiting of pregnancy (label; product-dependent). View labelExact | OTC sleep aid labeling is product-dependent; one common direction is 25 mg once nightly about 30 minutes before bed. | First-generation antihistamine (H1 antagonist) with sedating and anticholinergic effects; OTC sleep aid and antiemetic ingredient (doxylamine/pyridoxine). | Hepatic | Single-dose mean 10 h; Single-dose range 10–15 h | No | | - Sedation and next-day impairment (falls risk, driving safety).
- Anticholinergic effects (constipation, urinary retention, blurred vision).
- Confusion or delirium risk in older adults and polypharmacy (Beers).
- Avoid duplicate sedatives and document a stop plan if nightly use develops.
| No | 2025-12-30 |
|---|
| Insomnia (label). View labelExact | Typical starting dose is 5 mg once nightly immediately before bedtime, with at least 7 hours remaining before planned awakening; maximum 10 mg nightly (label). | Dual orexin receptor antagonist (DORA); orexin OX1R/OX2R antagonist. | CYP3A4 | Single-dose mean 18 h; Single-dose range 17–19 h | No | | - Next-day impairment (driving, work, falls) is assessed after initiation and dose changes; dose reduction or discontinuation may be considered when safety is compromised.
- REM intrusion symptoms (sleep paralysis, hallucinations) are screened for; discontinuation may be considered if they are distressing or dangerous.
- Interacting medications (CYP3A modulators) are reviewed, and alcohol or other CNS depressants are minimized when possible.
- Benefit is reassessed at each refill decision; ongoing use typically depends on meaningful improvement after an adequate trial.
| No | 2025-12-28 |
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