| Treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy (label). View labelExact | Adults: titrate weekly—8.9 mg once daily in the morning (week 1), 17.8 mg once daily (week 2), and may increase to 35.6 mg once daily (week 3) based on response and tolerability (label). | Histamine H3 receptor inverse agonist/antagonist (pitolisant) indicated for excessive daytime sleepiness and cataplexy in narcolepsy; non-scheduled but has clinically important QT prolongation risk at higher exposures and dose adjustments for CYP2D6 status and interacting medications. | CYP2D6, CYP3A4 | Single-dose mean 20 h | No | | - QT risk review (history, co-medications, exposure-increasing interactions) (label/clinical).
- Mood and psychiatric symptom monitoring (anxiety, agitation, mania/psychosis) (clinical).
- Sleep disruption monitoring (insomnia, circadian effects) (clinical).
- Drug interaction review (CYP2D6 inhibitors; CYP3A4 inducers; contraception) (label).
- Hepatic function status review for dosing safety (label).
| No | 2025-12-30 |
|---|
| Improve wakefulness in adults with excessive sleepiness associated with narcolepsy or obstructive sleep apnea (label). View labelExact | Administer once daily upon awakening; avoid dosing within 9 hours of planned bedtime (label). | Wakefulness-promoting dopamine and norepinephrine reuptake inhibitor (solriamfetol) indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy or obstructive sleep apnea; Schedule IV with dose-dependent blood pressure/heart rate effects and MAOI contraindication. | Minimal metabolism (minor inactive N-acetyl metabolite) | Single-dose mean 7.1 h | No | — | - Blood pressure and heart rate monitoring at baseline and periodically (label/clinical).
- Sleep disruption monitoring (insomnia, timing effects) (label/clinical).
- Mood and psychiatric symptom monitoring (anxiety, irritability, mania/psychosis) (label/clinical).
- Renal function review for dosing decisions and ongoing safety (label).
- Misuse/diversion risk monitoring consistent with Schedule IV status (clinical).
| No | 2026-02-12 |
|---|
| Improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, or shift work disorder (label). View labelExact | Narcolepsy or OSA: 200 mg once daily in the morning (label). | Wakefulness-promoting agent used for excessive sleepiness in narcolepsy, obstructive sleep apnea, and shift work disorder; Schedule IV with important rash/hypersensitivity warnings and clinically relevant CYP3A4 induction and CYP2C19 inhibition interactions. | CYP3A4, CYP2C19 | Steady-state mean 15 h | No | — | - Rash and hypersensitivity monitoring, especially during the first 1–5 weeks (label).
- Mood and psychiatric symptom monitoring (anxiety, agitation, mania/psychosis) (label/clinical).
- Sleep disruption monitoring (insomnia, timing effects) (clinical).
- Drug interaction review (CYP3A induction; CYP2C19 inhibition), including contraception counseling (label).
| No | 2025-12-30 |
|---|
| Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy; REMS-restricted (label). View labelExact | Adults: start 4.5 g per night in two doses (2.25 g at bedtime and 2.25 g 2.5–4 hours later). Titrate by 1.5 g per night at weekly intervals to an effective range of 6–9 g per night; doses above 9 g are not ordinarily administered (label). | Nighttime CNS depressant (sodium oxybate; oxybate/GHB) indicated for cataplexy and excessive daytime sleepiness in narcolepsy (patients 7+); Schedule III with boxed warning for CNS depression and abuse/misuse, and dispensed under a REMS due to risk of respiratory depression and misuse. | Non-CYP metabolism (GHB metabolic pathways) | Single-dose range 0.5–1 h | No | | - Respiratory risk and CNS depressant co-medication review (label/clinical).
- Safe storage and misuse/diversion monitoring consistent with REMS (label/clinical).
- Nighttime fall risk assessment and environment planning (clinical).
- Hepatic impairment assessment for dosing and safety (label).
- Review of interaction with divalproex/valproate if co-prescribed (label/clinical).
| No | 2026-02-22 |
|---|