The best time to treat a seizure is as early as possible

The best time to treat a seizure is as early as possible

The best time to treat a seizure is as early as possible

The longer a seizure is left untreated, the more difficult it may be to treat1,2

Within 10 to 15 minutes, benzodiazepine effectiveness may drop by more than 50%.1

Delay of acute intervention for recurrent or prolonged seizures has been linked to negative outcomes1-5

3.5 times the risk of premature death

Episodes of frequent seizures have been associated with a ~3.5x greater risk of premature death.3

44% risk of status epilepticus

Status epilepticus is more common in patients with episodes of frequent seizures.6

  • 44% compared with 12.5% of those without clusters (P<0.002)6

Episodes of frequent seizures have been associated with a >2.5-fold increased risk of SUDEP.3

Time is of the essence during a seizure

Treatment of prolonged seizures is often delayed in emergency and hospital settings.7

42 Minutes

42 minutes
(average time to treatment)

56 Minutes

56 minutes
(average time to hospital arrival)

From a review of 15 studies comprising 2,212 patients with epilepsy who were treated for status epilepticus.7

Early treatment intervention may circumvent physiological changes

Benzodiazepines are most effective when used early after a seizure starts, due to changes at the synapses that degrade GABA signaling over time.1,2

Your patients want to act, not wait

When episodes of frequent seizures occur, patients don’t want to wait to be “rescued.” Having an immediate-use seizure medication on hand allows patients and care partners to act quickly.

Seizure rescue medication or immediate-use seizure medication?
The term “seizure rescue medication” reinforces the notion that patients need to be saved. Instead, “immediate-use seizure medication” emphasizes how quickly the medication may be used to empower patients to treat sooner.

Treating early with an immediate-use seizure medication may help:

Terminate an episode of frequent seizures rapidly8

Stop prolonged seizure activity within an episode of frequent seizures when given early enough8

Talk with your patients about having the right immediate-use seizure medication on hand

Along with an antiseizure medication, having an intranasal immediate-use seizure medication that can be delivered soon after an episode of frequent seizures begins could provide more comprehensive management for more of your patients at risk.9,10

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An immediate-use seizure medication is the best way to ensure rapid treatment for episodes of frequent seizures

Discover an Intranasal Option

Indication

VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
  • The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
  • The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.

Contraindications: VALTOCO is contraindicated in patients with:

  • Hypersensitivity to diazepam
  • Acute narrow-angle glaucoma

Central Nervous System (CNS) Depression

Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits.

The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.

Glaucoma

Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

Neonatal Sedation and Withdrawal Syndrome

Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly.

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including “gasping syndrome,” can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Adverse Reactions

The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.

To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see full Prescribing Information, including Boxed Warning.

References

1. Naylor DE. Treating acute seizures with benzodiazepines: does seizure duration matter? Epileptic Disord. 2014;16(spec no 1):S69-S83. doi:10.1684/epd.2014.0691; 2. Niquet J, Baldwin R, Suchomelova L, et al. Benzodiazepine-refractory status epilepticus: pathophysiology and principles of treatment. Ann NY Acad Sci. 2016;1378(1):166-173. doi:10.1111/nyas.13147; 3. Sillanpää M, Schmidt D. Seizure clustering during drug treatment affects seizure outcome and mortality of childhood-onset epilepsy. Brain. 2008;131(pt 4):938-944. doi:10.1093/brain/awn037; 4. Sutula TP, Hagen J, Pitkänen A. Do epileptic seizures damage the brain? Curr Opin Neurol. 2003;16(2):189-195. doi:10.1097/01.wco.0000063770.15877.bc; 5. Gaínza-Lein M, Sánchez Fernández I, Jackson M, et al. Association of time to treatment with short-term outcomes for pediatric patients with refractory convulsive status epilepticus. JAMA Neurol. 2018;75(4):410-418. doi:10.1001/jamaneurol.2017.4382; 6. Haut SR, Shinnar S, Moshé SL, O’Dell C, Legatt AD. The association between seizure clustering and convulsive status epilepticus in patients with intractable complex partial seizures. Epilepsia. 1999;40(12):1832-1834. doi:10.1111/j.1528-1157.1999.tb01607.x; 7. Gaínza-Lein M, Sánchez Fernández I, Ulate-Campos A, Loddenkemper T, Ostendorf AP. Timing in the treatment of status epilepticus: from basics to the clinic. Seizure. 2019;68:22-30. doi:10.1016/j.seizure.2018.05.021; 8. Misra SN, Jarrar R, Stern JM, Becker DA, Carrazana E, Rabinowicz AL. Rapid rescue treatment with diazepam nasal spray leads to faster seizure cluster termination in epilepsy: an exploratory post hoc cohort analysis. Neurol Ther. 2024;13(1):221-231. doi:10.1007/s40120-023-00568-4; 9. O’Dell C, Wheless JW, Cloyd J. The personal and financial impact of repetitive or prolonged seizures on the patient and family. J Child Neurol. 2007;22(5)(suppl):61S-70S. doi:10.1177/0883073807303070; 10. Seizure rescue therapies. Epilepsy Foundation. April 14, 2019. Accessed April 7, 2025. https://www.epilepsy.com/treatment/seizure-rescue-therapies

1. Valtoco. Prescribing Information. Neurelis Inc; 2024; 2. Placeholder reference for the FDA approval letter; 3. Data on file. REF-01245. Neurelis Inc; 4. Data on file. REF-01288. Neurelis Inc; 5. Wheless JW, Miller I, Hogan RE, et al; DIAZ.001.05 Study Group. Final results from a Phase 3, long-term, open-label, repeat-dose safety study of diazepam nasal spray for seizure clusters in patients with epilepsy. Epilepsia. 2021;62(10):2485-2495. doi:10.1111/epi.17041; 6. Tarquinio D, Dlugos D, Wheless JW, et al. Safety of Valtoco® (diazepam nasal spray) in children and adolescents with epilepsy: final subgroup results from a phase 3, long-term, open-label, repeat-dose safety study. Poster presented at: Child Neurology Society 50th Annual Meeting; September 29 – October 2, 2021; Boston, MA; 7. Penovich P, Wheless JW, Hogan RE, et al. Examining the patient and caregiver experience with diazepam nasal spray for seizure clusters: results from an exit survey of a phase 3, open-label, repeat-dose safety study. Epilepsy Behav. 2021;121(pt A):108013. doi:10.1016/j.yebeh.2021.108013; 8. Misra SN, Sperling MR, Rao VR, et al. Significant improvements in SEIzure interVAL (time between seizure clusters) across time in patients treated with diazepam nasal spray as intermittent rescue therapy for seizure clusters. Epilepsia. 2022;63(10):2684-2693. doi:10.1111/epi.17385

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If your patient was prescribed VALTOCO, myNEURELIS® is here to help them every step of the way. Learn more about the benefits and support offerings:

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All other trademarks are the property of their respective owners.

© Neurelis, Inc. 2025. All rights reserved. US-PRC-23-00258-v4 04/2025

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
  • The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
  • The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.
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