Effects of diazepam nasal spray: A Synthesis of Findings from 15 Studies

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Original Abstract of the Article

Key Findings

Multiple studies have demonstrated that diazepam nasal spray is a safe and effective treatment for seizure clusters in people with epilepsy. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 These studies indicate that diazepam nasal spray is effective in treating seizure clusters and may help reduce the frequency of these events. 5 Diazepam nasal spray has also shown potential for improving the quality of life for patients with epilepsy. 6 Furthermore, diazepam nasal spray appears to maintain its safety profile when used concurrently with other anti-seizure medications like cannabidiol. 4 Importantly, diazepam nasal spray has been shown to be safe for use in a wide range of age groups, including children, adults, and patients with developmental epileptic encephalopathies. 2 , 7

Benefits and Risks

Benefits Summary

Diazepam nasal spray is an effective and safe treatment option for seizure clusters in people with epilepsy. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 It is effective in treating seizure clusters, and may help reduce the frequency of these events. 5 Diazepam nasal spray can improve the quality of life for patients with epilepsy. 6 Diazepam nasal spray maintains its safety profile when used concurrently with other anti-seizure medications. 4 It is safe for use in a wide range of age groups, including children, adults, and patients with developmental epileptic encephalopathies. 2 , 7

Risks Summary

Side effects from diazepam nasal spray are generally mild to moderate. 3 The most common side effect is nasal discomfort. 13 Diazepam nasal spray, like other benzodiazepines, can cause side effects such as drowsiness, dizziness, and unsteadiness. 12 Diazepam nasal spray can also cause respiratory depression. 3 Diazepam nasal spray should be used with caution in pregnant and breastfeeding women. 13 Avoid combining diazepam nasal spray with alcohol or other sedatives. 13

Study Comparisons

Commonalities

These studies collectively highlight that diazepam nasal spray is a safe and effective treatment for seizure clusters in people with epilepsy. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 Moreover, they consistently show that diazepam nasal spray maintains its safety profile even when combined with other anti-seizure medications like cannabidiol. 4

Differences

The studies differ in their inclusion criteria, sample sizes, and research designs. For example, 4 examined the combined effects of diazepam nasal spray and cannabidiol, while 11 focused on assessing the safety and efficacy of diazepam nasal spray based on usage frequency. 2 was focused on pediatric patients with developmental epileptic encephalopathies while 7 was focused on children and adolescents with epilepsy. These variations in study design offer a more comprehensive understanding of the effects and safety profile of diazepam nasal spray.

Consistency and Contradictions

The studies consistently indicate that diazepam nasal spray is a safe and effective treatment for seizure clusters in people with epilepsy. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 The results consistently show that diazepam nasal spray side effects are generally mild to moderate. 3 , 13 However, these studies do not fully evaluate the long-term safety of diazepam nasal spray or its impact on seizure cluster frequency or severity. The studies vary in their inclusion criteria, sample sizes, and research designs. 4 , 11 These variations limit our ability to gain a more in-depth understanding of the effects and safety profile of diazepam nasal spray.

Practical Considerations

Diazepam nasal spray has been shown to be a beneficial treatment for seizure clusters in people with epilepsy. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 However, diazepam nasal spray, like other benzodiazepines, can cause side effects such as drowsiness, dizziness, and unsteadiness. 12 Therefore, avoid driving or operating heavy machinery after using diazepam nasal spray. Also, avoid combining it with alcohol or other sedatives. 13 Exercise caution when using diazepam nasal spray during pregnancy or breastfeeding. 13 Always follow your doctor's instructions when using diazepam nasal spray.

Limitations of Current Research

The studies have not fully evaluated the long-term safety of diazepam nasal spray or its impact on seizure cluster frequency or severity. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 Furthermore, the studies vary in their inclusion criteria, sample sizes, and research designs. 4 , 11 As a result, we cannot fully comprehend the effects and safety profile of diazepam nasal spray.

Future Research Directions

Future research should focus on evaluating the long-term safety of diazepam nasal spray, as well as its impact on seizure cluster frequency and severity. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 Studies are also needed to determine the optimal dosage and the efficacy of diazepam nasal spray across different age groups.

Conclusion

Diazepam nasal spray has emerged as a safe and effective treatment for seizure clusters in people with epilepsy, based on a collection of studies. 4 , 11 , 10 , 3 , 15 , 9 , 2 , 13 , 1 , 14 , 12 , 5 , 6 , 8 , 7 These studies show that diazepam nasal spray is effective in treating seizure clusters, and may help reduce the frequency of these events. 5 It can also improve the quality of life for patients with epilepsy. 6 Diazepam nasal spray maintains its safety profile when used concurrently with other anti-seizure medications. 4 It is safe for use in a wide range of age groups, including children, adults, and patients with developmental epileptic encephalopathies. 2 , 7 However, further research is needed to fully assess the long-term safety of diazepam nasal spray and its impact on seizure cluster frequency and severity.

Literature analysis of 15 papers
Positive Content
13
Neutral Content
1
Negative Content
1
Article Type
1
0
0
2
15
1.

A randomized, open-label, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of diazepam nasal spray in healthy adults.

Author: RogawskiMichael A, SlatkoGary

Gastrointestinal side effects

This study investigated the potential effects of food on the pharmacokinetics of diazepam nasal spray in healthy adults. While nasal diazepam is typically thought to be primarily absorbed via the nasal mucosa, gastrointestinal side effects suggest some enteral absorption. This study aimed to evaluate the impact of food on the absorption and pharmacokinetic profile of diazepam nasal spray.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Safety of Diazepam Nasal Spray in Pediatric Patients With Developmental Epileptic Encephalopathies: Results From a Long-term Phase 3 Safety Study.

Author: TarquinioDaniel, WhelessJames W, SegalEric B, MisraSunita N, RabinowiczAdrian L, CarrazanaEnrique

Diazepam nasal spray efficacy
Diazepam nasal spray safety
Epilepsy treatment
Epistaxis

This post hoc analysis of a long-term safety study evaluated the safety and effectiveness of diazepam nasal spray as rescue therapy for seizure clusters in patients with pediatric developmental epileptic encephalopathies. The analysis found a consistent safety profile across various developmental epileptic encephalopathies, supporting its use in these challenging patient populations.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Treatment of Seizure Clusters in Epilepsy: A Narrative Review on Rescue Therapies.

Author: BeckerDanielle A, WhelessJames W, SirvenJoseph, TatumWilliam O, RabinowiczAdrian L, CarrazanaEnrique

Improved seizure management
Seizure cluster treatment
Mild to moderate adverse events

This review discusses the use of rescue medications for seizure clusters in epilepsy. It highlights the effectiveness of intranasal benzodiazepines, such as midazolam nasal spray and diazepam nasal spray, in treating seizure clusters and improving patient and caregiver satisfaction. The implementation of acute seizure action plans is crucial to facilitate the optimal use of rescue medications for improved seizure cluster management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Concomitant cannabidiol does not impact safety and effectiveness of diazepam nasal spray for seizure clusters: Post hoc analysis of a phase 3 safety study.

Author: PetersJurriaan M, PuriVinay, SegalEric, MisraSunita N, RabinowiczAdrian L, CarrazanaEnrique

Diazepam nasal spray effectiveness
Seizure cluster treatment
CBD interaction
Diazepam side effects

This analysis examined the safety and effectiveness of intermittent use of diazepam nasal spray in patients with seizure clusters who also received CBD treatment. Results suggest that CBD does not alter the safety and effectiveness of diazepam nasal spray and supports concomitant use in appropriate patients.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

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.

Author: MisraSunita N, SperlingMichael R, RaoVikram R, PetersJurriaan M, DavisCharles, CarrazanaEnrique, RabinowiczAdrian L

Abort seizure cluster

This analysis explores the impact of intermittent rescue therapy with diazepam nasal spray (Valtoco) on the time between seizure clusters (SEIVAL) in patients with epilepsy. The study aimed to assess how intermittent rescue therapy affects the long-term natural course of seizure clusters.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Quality-of-life results in adults with epilepsy using diazepam nasal spray for seizure clusters from a long-term, open-label safety study.

Author: CramerJoyce A, FaughtEdward, DavisCharles, MisraSunita N, CarrazanaEnrique, RabinowiczAdrian L

QoL impact
Seizure clusters

Epilepsy is a condition characterized by seizures. This study examines the quality of life of adult epilepsy patients who experience seizure clusters, which are periods of frequent seizures. It investigates how the use of diazepam nasal spray, a medication for treating seizures, affects quality of life.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Safety of Diazepam Nasal Spray in Children and Adolescents With Epilepsy: Results From a Long-Term Phase 3 Safety Study.

Author: TarquinioDaniel, DlugosDennis, WhelessJames W, DesaiJay, CarrazanaEnrique, RabinowiczAdrian L

Safe treatment

Diazepam nasal spray demonstrated a consistent safety profile across age subgroups in patients with seizure clusters.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Use of second doses of Valtoco® (diazepam nasal spray) across 24 hours after the initial dose for out-of-hospital seizure clusters: Results from a phase 3, open-label, repeat-dose safety study.

Author: SperlingMichael R, WhelessJames W, HoganR Edward, DlugosDennis, CascinoGregory D, LiowKore, RabinowiczAdrian L, CarrazanaEnrique,

Diazepam nasal spray
Seizure control
Seizure clusters

Diazepam nasal spray was found to be safe and effective for the treatment of seizure clusters for up to 24 hours. A second dose of the spray was used in less than half of patients and rates of adverse events were low.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

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.

Author: WhelessJames W, MillerIan, HoganR Edward, DlugosDennis, BitonVictor, CascinoGregory D, SperlingMichael R, LiowKore, VazquezBlanca, SegalEric B, TarquinioDaniel, MauneyWeldon, DesaiJay, RabinowiczAdrian L, CarrazanaEnrique,

Epilepsy treatment
Seizure cluster management
Dysgeusia
Epistaxis
Headache
Nasal discomfort
Somnolence

Diazepam nasal spray was found to be safe and effective in patients with epilepsy and frequent seizure clusters. In a large open-label safety study involving 163 patients, the safety profile was consistent with rectal diazepam. The most common side effects were nasal discomfort, headache, dysgeusia, epistaxis, and somnolence. A second dose was used in only 12.6% of seizure clusters.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

A review of a diazepam nasal spray for the treatment of acute seizure clusters and prolonged seizures.

Author: HigdonLindsay M, SperlingMichael R

Improved quality of life
Rescue medication
Risk of injury

Acute repetitive seizures (ARS) in epilepsy patients can negatively impact quality of life, daily function, and increase healthcare utilization. Intranasal benzodiazepines are a promising at-home rescue medication option as they are socially acceptable and easier to administer than rectal drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Consistent safety and tolerability of Valtoco<sup>&#174;</sup> (diazepam nasal spray) in relationship to usage frequency in patients with seizure clusters: Interim results from a phase 3, long-term, open-label, repeat-dose safety study.

Author: MillerIan, WhelessJames W, HoganRobert E, DlugosDennis, BitonVictor, CascinoGregory D, SperlingMichael R, LiowKore, VazquezBlanca, SegalEric B, TarquinioDaniel, MauneyWeldon, DesaiJay, RabinowiczAdrian L, CarrazanaEnrique,

Seizure cluster treatment

Diazepam nasal spray is a safe and effective rescue therapy for seizure clusters in patients with epilepsy. This analysis of interim data from a phase 3 safety study found a favorable safety profile and effectiveness using average doses per month as a measure.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Evaluation of diazepam nasal spray in patients with epilepsy concomitantly using maintenance benzodiazepines: An interim subgroup analysis from a phase 3, long-term, open-label safety study.

Author: SegalEric B, TarquinioDaniel, MillerIan, WhelessJames W, DlugosDennis, BitonVictor, CascinoGregory D, DesaiJay, HoganR Edward, LiowKore, SperlingMichael R, VazquezBlanca, CookDavid F, RabinowiczAdrian L, CarrazanaEnrique,

Noninvasive
Rapid
Socially acceptable

This study evaluated the safety profile of diazepam nasal spray in patients with epilepsy. Diazepam nasal spray demonstrated a favorable safety profile in patients with and without concomitant use of benzodiazepines.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters.

Author: CloydJames, HautSheryl, CarrazanaEnrique, RabinowiczAdrian L

Seizure cluster treatment
Nasal discomfort

Diazepam nasal spray is a new formulation for treating seizure clusters. It has a bioavailability of 97% compared to intravenous diazepam and is more consistent than rectal gel. The nasal spray is well tolerated with low rates of nasal discomfort.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Pharmacokinetics and safety of VALTOCO (NRL-1; diazepam nasal spray) in patients with epilepsy during seizure (ictal/peri-ictal) and nonseizure (interictal) conditions: A phase 1, open-label study.

Author: HoganRobert Edward, TarquinioDaniel, SperlingMichael R, KleinPavel, MillerIan, SegalEric B, RabinowiczAdrian L, CarrazanaEnrique

Safe diazepam administration
Adverse events

Diazepam nasal spray pharmacokinetics were similar in seizure and nonseizure states in patients with epilepsy, suggesting its suitability for both ictal and interictal administration. The safety profile was consistent with that of diazepam.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Dosing feasibility and tolerability of intranasal diazepam in adults with epilepsy.

Author: SperlingMichael R, HaasKevin F, KraussGregory, Seif EddeineHussam, HenneyHerbert R, RabinowiczAdrian L, BreamGary, SquillacoteDavid, CarrazanaEnrique J

Effective diazepam delivery
Well tolerated
Nasopharyngeal signs
Post-dose seizures

Diazepam nasal spray (diazepam-NS) was found to be feasible and effective in treating seizures in adults with epilepsy. Therapeutic concentrations were achieved when administered during convulsive tonic-clonic seizures or in the postictal periods following tonic-clonic or other seizure types.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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