tasimelteonAdjunctive therapyBrands: Hetlioz, Hetlioz LQ | Treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults (label). View labelExact | Adults: 20 mg taken 1 hour before bedtime, at the same time every night; administer without food (label). | Melatonin receptor agonist (tasimelteon; MT1/MT2) indicated for treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults; requires consistent nightly dosing and may take weeks to months for effect, with clinically important CYP1A2/CYP3A4 interaction considerations. | CYP1A2, CYP3A4 | Single-dose mean 1.3 h | No | | - Next-day somnolence monitoring and fall risk assessment (label/clinical).
- Drug interaction review (CYP1A2 inhibitors; CYP3A4 inducers; smoking) (label/clinical).
- Consistency tracking (dose timing and sleep timing) to interpret response (clinical).
- Reassessment interval planning given delayed onset of circadian effects (clinical).
- Circadian tracking (sleep-wake diary; actigraphy when available) and evaluation for comorbid sleep disorders when response is unclear (clinical).
| No | 2025-12-30 |
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| 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 |
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| 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 |
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| 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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