Skip to content
PubMed This is a summary of 15 peer-reviewed journal articles Updated
Pediatric Neurology

Is Ospolot (Sulthiame) Used for Rolandic Epilepsy in the US?

At a Glance

Ospolot (sulthiame) is not FDA-approved or routinely available in the United States for Rolandic epilepsy, so families should not buy it online. A pediatric epilepsy specialist can discuss observation, levetiracetam, oxcarbazepine, and a seizure safety plan.

Ospolot (sulthiame) is used or recommended in some countries outside the United States as a treatment for Rolandic epilepsy (also called Self-limited epilepsy with centrotemporal spikes, or SeLECTS) [1]. However, it is not currently approved by the US Food and Drug Administration (FDA) [1][2]. This means it is not routinely marketed or stocked in US pharmacies. While clinicians can sometimes navigate complex expanded-access pathways, the lack of an established commercial supply makes it very difficult to obtain safely, and families should never purchase unregulated medication online.

If you are researching international treatments, it can be frustrating to find a medication that is unavailable locally. Fortunately, US pediatric epileptologists have deep experience managing SeLECTS using observation or other well-studied medications—such as levetiracetam or oxcarbazepine—that are commonly used for focal seizures [3].

Why is Sulthiame Used in Other Countries?

In regions where it is available, sulthiame is often considered because it reduces the distinctive electrical spikes seen on an electroencephalogram (EEG) (a test that measures brain waves) during sleep [4][5]. Short-term studies suggest sulthiame can reduce these abnormal brain waves without causing measurable negative impacts on a child’s cognitive performance [4].

However, the international evidence is not uniform. A major independent review of medical literature (the Cochrane review) concluded that the evidence comparing sulthiame to other medications is of “low certainty” [1]. While sulthiame is an option in some countries, large-scale data has not definitively proven that it is superior to US alternatives for stopping clinical seizures. Furthermore, reducing EEG spikes does not automatically guarantee seizure freedom or long-term protection of learning [1][6].

Standard US Approaches for Rolandic Epilepsy

Because SeLECTS is usually “self-limited”—meaning seizures often naturally remit by mid-adolescence [7]—treatment is highly individualized.

Observation Without Medication

If a child’s seizures are mild, infrequent, and happen only during sleep without impacting their daytime learning or behavior, doctors may recommend a “wait and see” approach [7]. However, “self-limited” does not mean the condition is always benign; significant changes in language, learning, or behavior warrant prompt medical evaluation [8][9].

Common US Medication Options

When medication is needed—due to frequent seizures, daytime seizures, or developmental concerns—US doctors typically consider the following options:

Levetiracetam (Keppra)

Levetiracetam is frequently used in the US to reduce both clinical seizures and abnormal sleep spikes on an EEG [4][10][6].

  • Cognition and Behavior: While studies show it generally does not worsen a child’s visuospatial abilities (skills like judging distance and spatial relationships) [11], levetiracetam is known to cause behavioral side effects in some children, including irritability, aggression, or mood changes [4].
  • Dosing: Some specific formulations of levetiracetam have been studied for once-nightly dosing to help with sleep and adherence [12]. However, dosing depends entirely on the specific formulation (immediate vs. extended-release), kidney function, and the child’s needs. Never change, combine, split, or stop doses without your prescriber’s explicit instructions, as abrupt changes can trigger seizures.

Oxcarbazepine (Trileptal)

Oxcarbazepine is another effective option for focal seizures [3].

  • Side Effects: Common side effects include dizziness, sedation, nausea, and low blood sodium. Rarely, it can cause a severe skin rash.
  • EEG Monitoring: In uncommon cases, oxcarbazepine has been associated with worsening the electrical brain activity during sleep, leading to a pattern sometimes called Electrical Status Epilepticus in Sleep (ESES) or DEE-SWAS [13]. This pattern can also emerge from the epilepsy itself. If your child suddenly struggles with learning, memory, or behavior, contact your neurologist promptly—they may order a sleep EEG to investigate [8][9].

Seizure Safety and Action Plan

Since nighttime seizures are common in SeLECTS, every family needs a basic safety plan:

  • During a seizure: Keep the child safe by rolling them onto their side. Do NOT restrain them or put anything in their mouth.
  • When to call emergency services: Call if a seizure lasts 5 minutes or longer, if repeated seizures occur without the child waking up in between, if they have difficulty breathing, or if they are injured.
  • Ask your doctor if your child needs a specific “rescue medication” for prolonged seizures, as well as basic bathing and water safety precautions.

Medication Comparison Summary

Approach When Considered Notable Side Effects & Risks Monitoring Needs
Observation Infrequent, mild, sleep-only seizures Risk of recurrent seizures Regular monitoring of school performance, language, and behavior
Levetiracetam Frequent or daytime seizures; EEG concerns Irritability, mood changes, aggression, sleepiness Watch for mood/behavior shifts; do not alter doses independently
Oxcarbazepine Frequent focal seizures Dizziness, low sodium, nausea, rare severe rash Watch for sudden learning/language regression (possible ESES); potential sodium checks
Sulthiame Used in some countries; not FDA-approved in US Somnolence/drowsiness, aggression, rare severe rash [14][15] Extremely difficult to obtain safely in the US; do not buy online

Common questions in this guide

Is Ospolot (sulthiame) available for Rolandic epilepsy in the US?
Ospolot (sulthiame) is not approved by the US Food and Drug Administration for Rolandic epilepsy, also called SeLECTS, so most US pharmacies do not market or stock it. In unusual cases, a clinician may explore an expanded-access pathway, but families should not buy unregulated medication online.
Why do some countries use sulthiame for Rolandic epilepsy?
Sulthiame can reduce the unusual electrical spikes seen on a child's brain-wave test during sleep. Studies suggest this may occur without measurable short-term harm to thinking or learning, but the overall evidence is uncertain, and fewer EEG spikes do not necessarily mean seizure freedom or long-term protection of learning.
What treatments are commonly considered in the United States for SeLECTS?
If seizures are mild, infrequent, occur only during sleep, and do not affect daytime learning or behavior, a pediatric neurologist may recommend observation without medication. When treatment is needed, clinicians may consider levetiracetam or oxcarbazepine based on the seizure pattern, EEG findings, side-effect risks, and the child's needs.
What changes should prompt a sleep EEG for a child with Rolandic epilepsy?
A sudden or worsening problem with learning, memory, language, attention, or behavior should be reported promptly to the child's neurologist. The clinician may order a sleep EEG to look for an abnormal sleep-related electrical pattern such as ESES or DEE-SWAS.
When is a seizure an emergency, and what should I do?
Call emergency services if a seizure lasts five minutes or longer, repeats without the child waking between seizures, causes breathing trouble, or leads to an injury. Roll the child onto their side, do not restrain them or put anything in their mouth, and ask the neurologist whether a rescue medicine is appropriate.
What side effects can levetiracetam or oxcarbazepine cause?
Levetiracetam can cause irritability, aggression, or other mood and behavior changes. Oxcarbazepine can cause dizziness, sleepiness, nausea, low blood sodium, and rarely a severe skin rash; never change or stop either medicine without the prescriber's instructions.

Questions to Ask Your Doctor

Curated prompts to bring to your next appointment.

  1. 1.Given my child's seizure frequency and timing, is medication necessary right now, or is observation a safe option?
  2. 2.If we start medication, what is the exact formulation and schedule, and what side effects should prompt me to call you the same day?
  3. 3.Do we need a specific seizure rescue plan or rescue medication for home and school?
  4. 4.What specific changes in learning, language, or behavior would justify repeating a sleep EEG or ordering a neuropsychological assessment?
  5. 5.If my child takes levetiracetam or oxcarbazepine, how will we monitor whether it is helping their cognitive development versus just stopping the physical seizures?

Questions For You

Tap a prompt to share your answer — we'll use it plus this page's context to start a tailored conversation.

References

References (15)
  1. 1

    Sulthiame monotherapy for epilepsy.

    Milburn-McNulty P, Panebianco M, Marson AG

    The Cochrane database of systematic reviews 2021; (9()):CD010062 doi:10.1002/14651858.CD010062.pub3.

    PMID: 34554571
  2. 2

    Sultiame pharmacokinetic profile in plasma and erythrocytes after single oral doses: A pilot study in healthy volunteers.

    Dao K, Thoueille P, Decosterd LA, et al.

    Pharmacology research & perspectives 2020; (8(1)):e00558 doi:10.1002/prp2.558.

    PMID: 31990440
  3. 3

    A Systematic Review of Seizure-Freedom Rates in Patients With Benign Epilepsy of Childhood With Centrotemporal Spikes Receiving Antiepileptic Drugs.

    Gerstl L, Willimsky E, Rémi C, et al.

    Clinical neuropharmacology 2021; (44(2)):39-46 doi:10.1097/WNF.0000000000000435.

    PMID: 33605607
  4. 4

    Effect of anticonvulsive treatment on neuropsychological performance in children with BECTS.

    Tacke M, Gerstl L, Heinen F, et al.

    European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society 2016; (20(6)):874-879 doi:10.1016/j.ejpn.2016.07.015.

    PMID: 27553576
  5. 5

    Effects of Levetiracetam and Sulthiame on EEG in benign epilepsy with centrotemporal spikes: A randomized controlled trial.

    Tacke M, Borggraefe I, Gerstl L, et al.

    Seizure 2018; (56()):115-120 doi:10.1016/j.seizure.2018.01.015.

    PMID: 29475094
  6. 6

    The fate of spikes in self-limited epilepsy with centrotemporal spikes: Are clinical and baseline EEG features effective?

    Günay Ç, Sarikaya Uzan G, Özsoy Ö, et al.

    Epilepsy research 2023; (193()):107165 doi:10.1016/j.eplepsyres.2023.107165.

    PMID: 37201400
  7. 7

    Beta oscillations in the sensorimotor cortex correlate with disease and remission in benign epilepsy with centrotemporal spikes.

    Song DY, Stoyell SM, Ross EE, et al.

    Brain and behavior 2019; (9(3)):e01237 doi:10.1002/brb3.1237.

    PMID: 30790472
  8. 8

    Cognitive functioning in children with self-limited epilepsy with centrotemporal spikes: A systematic review and meta-analysis.

    Wickens S, Bowden SC, D'Souza W

    Epilepsia 2017; (58(10)):1673-1685 doi:10.1111/epi.13865.

    PMID: 28801973
  9. 9

    ADHD and ADHD-related neural networks in benign epilepsy with centrotemporal spikes: A systematic review.

    Aricò M, Arigliani E, Giannotti F, Romani M

    Epilepsy & behavior : E&B 2020; (112()):107448 doi:10.1016/j.yebeh.2020.107448.

    PMID: 32916583
  10. 10

    Cognitive profile in BECTS treated with levetiracetam: A 2-year follow-up.

    Operto FF, Pastorino GMG, Mazza R, et al.

    Epilepsy & behavior : E&B 2019; (97()):187-191 doi:10.1016/j.yebeh.2019.05.046.

    PMID: 31252277
  11. 11

    Prospective Assessment of Cognitive Outcomes in Pediatric Self-Limited Epilepsy With Centrotemporal Spikes.

    Kızıl H, Ayca S, Şahin K, Elevli M

    Epilepsy & behavior : E&B 2026; (180()):111052 doi:10.1016/j.yebeh.2026.111052.

    PMID: 41985205
  12. 12

    Safety and efficacy of one-dose nocturnal levetiracetam for the treatment of self-limited epilepsy with centrotemporal spikes: a randomized clinical trial.

    Fan L, Shen Y, Zhang J, et al.

    Scientific reports 2025; (15(1)):34302 doi:10.1038/s41598-025-11906-x.

    PMID: 41034293
  13. 13

    Encephalopathy with status epilepticus during sleep (ESES) induced by oxcarbazepine in idiopathic focal epilepsy in childhood.

    Pavlidis E, Rubboli G, Nikanorova M, et al.

    Functional neurology 2015; (30(2)):139-41 doi:10.11138/fneur/2015.30.2.139.

    PMID: 26415787
  14. 14

    Sulthiame use in children with pharmacoresistant epilepsies: A retrospective study.

    Laliberté A, Berrahmoune S, Myers KA

    Epileptic disorders : international epilepsy journal with videotape 2024; (26(5)):591-599 doi:10.1002/epd2.20250.

    PMID: 38818757
  15. 15

    Sulthiame-induced drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

    Fong CY, Hashim N, Gan CS, et al.

    European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society 2016; (20(6)):957-961 doi:10.1016/j.ejpn.2016.07.023.

    PMID: 27524391

This page explains sulthiame availability and treatment options for SeLECTS for informational purposes only and does not constitute medical advice. Your child's pediatric neurologist should guide medication choices, dosing, and seizure safety planning.

Get notified when new evidence is published on Self-limited epilepsy with centrotemporal spikes.

We monitor PubMed for new peer-reviewed studies on this topic and email a short summary when something meaningful changes.