Interactions between Belsomra and Stiripentol
1 drug interaction and 19 additional warnings found for the following 2 drugs:
- Belsomra (suvorexant)
- stiripentol
Drug interactions
Moderate drug interactions
Moderate:
stiripentol suvorexant
Applies to: stiripentol and Belsomra (suvorexant)
Monitor
Coadministration with inhibitors of CYP450 1A2 and/or 3A4 may increase the plasma concentrations of stiripentol, which has been shown in vitro to undergo phase I metabolism via these pathways. Conversely, many of these inhibitors are also substrates of CYP450 1A2 and/or 3A4, and coadministration with stiripentol may alter their plasma concentrations as well. Stiripentol is both an inhibitor and inducer of CYP450 1A2 and 3A4 in vitro. Pharmacokinetic studies in humans are limited; therefore, it is uncertain whether plasma concentrations of concomitantly administered drugs may increase or decrease.
Management
Caution is advised when stiripentol is used with inhibitors of CYP450 1A2 and/or 3A4 that are also substrates of these enzymatic pathways. Patients should be monitored for potentially increased adverse effects of stiripentol such as anorexia, nausea, vomiting, weight loss, somnolence, dizziness, confusion, difficulty concentrating, ataxia, hypotonia, tremor, hyperkinesia, dysarthria, suicidal ideation/behavior, neutropenia, and thrombocytopenia. In addition, clinical and laboratory monitoring may be appropriate for concomitant drugs whenever stiripentol is added to or withdrawn from therapy. Dosage adjustments or alternative treatments may be required if an interaction is suspected.
References (3)
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
- (2018) "Product Information. Diacomit (stiripentol)." Biocodex USA
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
stiripentol Food/Lifestyle
Applies to: stiripentol
Generally avoid
Taking stiripentol on an empty stomach may reduce its oral bioavailability. Stiripentol degrades rapidly when exposed to gastric acid in an empty stomach.
Generally avoid
Alcohol may potentiate the depressant effects of stiripentol on the central nervous system. Concomitant use may result in increased sedation and dizziness as well as impairment of psychomotor skills.
Generally avoid
It is not known whether stiripentol may reduce theophylline and caffeine metabolism, as data on the potential for inhibition of CYP450 1A2 are limited. Consumption of foods and nutritional products such as cola drinks (which contain significant quantities of caffeine) and chocolate (which contains caffeine and trace amounts of theophylline) may be unsafe during treatment with stiripentol, particularly in children.
Management
Stiripentol should be taken during a meal for optimal absorption; however, it should not be taken with milk, dairy products (e.g., yogurt, soft cream cheese), fruit juice, or carbonated beverages. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them. Food and beverages that may contain caffeine or theophylline such as colas, chocolate, coffee, tea, or energy drinks should also be avoided during treatment with stiripentol.
References (3)
- Canadian Pharmacists Association (2006) e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink
- EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
- (2018) "Product Information. Diacomit (stiripentol)." Biocodex USA
Moderate:
suvorexant Food/Lifestyle
Applies to: Belsomra (suvorexant)
Generally avoid
Alcohol may potentiate some of the pharmacologic effects of suvorexant. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills. In addition, alcohol may increase the risk of cognitive and complex behavioral changes associated with the use of hypnotics including suvorexant, such as amnesia, anxiety, hallucinations, sleep-driving, and other neuropsychiatric symptoms.
Adjust dose
Grapefruit juice may significantly increase the plasma concentrations of suvorexant. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit.
Adjust dosing interval
Administration with or soon after a meal may delay the gastrointestinal absorption of suvorexant. According to the product labeling, administration of suvorexant with a high-fat meal resulted in no meaningful change in peak plasma concentration (Cmax) or systemic exposure (AUC), but a delay in Tmax of approximately 1.5 hours.
Management
Concomitant use of suvorexant with alcohol should be avoided. Patients should be advised not to use suvorexant if they had alcohol that evening or before bed. Grapefruit juice should preferably be avoided; otherwise, the recommended dose of suvorexant is 5 mg when used with grapefruit juice and should not exceed 10 mg. Suvorexant may be taken with or without food; however, for faster sleep onset, suvorexant should not be administered with or soon after a meal.
References (1)
- (2014) "Product Information. Belsomra (suvorexant)." Merck & Co., Inc
Disease interactions
17 potential interactions Applies to: 14 conditions, including Depression, Narcolepsy, Psychosis, Urinary Retention, and Liver Disease.
Bone Marrow Depression/Low Blood Counts
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Bone Marrow Depression/Low Blood Counts.
Stiripentol can cause a significant decline in neutrophil and platelet counts. Care should be exercised when prescribing this agent to immunosuppressed patients and those with bone marrow suppression. Hematologic testing should be obtained before starting treatment, and then every 6 months.
Central Nervous System Disorders
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Central Nervous System Disorders.
Stiripentol can cause somnolence. If somnolence occurs during coadministration with clobazam, an initial reduction of clobazam by 25% should be considered. If somnolence persists, further clobazam reduction by an additional 25% should be considered, as well as adjustment of the dosage of other concomitant anticonvulsant drugs with sedating properties. Caution should be exercised when prescribing this agent to patients with CNS disorders. Prescribers should monitor patients for somnolence and should caution patients against engaging in hazardous activities requiring mental alertness (e.g., operating dangerous machinery/motor vehicles) until they know how stiripentol affects them.
Depression
Major:
Belsomra
The suvorexant in Belsomra has a major potential interaction with Depression.
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of most anxiolytics, sedatives and hypnotics. Some of these changes include decreased inhibition, aggressiveness, agitation, and hallucinations. These drugs can cause or exacerbate mental depression and cause suicidal behavior and ideation. Therapy with these drugs should be administered cautiously in patients with a history of depression or other psychiatric disorders. Patients should be monitored for any changes in mood or behavior. It may be prudent to refrain from dispensing large quantities of medication to these patients.
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Depression.
Antiepileptic drugs (AEDs) have been associated with an increased risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Pooled analyses of 199 placebo-controlled clinical studies involving the use of 11 different AEDs showed that patients receiving AEDs had approximately twice the risk of suicidal thinking or behavior compared to patients receiving placebo. AEDs should be administered cautiously in patients with depression or other psychiatric disorders; phentermine-topiramate should be avoided in patients with history of suicidal attempts or active suicidal ideation. The risk of suicidal thoughts and behavior should be carefully assessed against the risk of untreated illness, bearing in mind that epilepsy and many other conditions for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, caregivers, and families should be alert to the emergence or worsening of signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior. If patients have symptoms of suicidal ideation or behavior, a dosage reduction or treatment discontinuation should be considered.
Failure to Thrive
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Failure to Thrive.
Stiripentol can cause decreases in appetite and weight; nausea and vomiting also occurred more often in stiripentol-treated patients. The growth of pediatric patients should be carefully monitored. In some cases, decreasing the dose of concomitant valproate by 30% per week can reduce the decrease in appetite and weight. Caution should be exercised when prescribing this agent to patients at risk.
Glaucoma/Intraocular Hypertension
Moderate:
Belsomra
The suvorexant in Belsomra has a moderate potential interaction with Glaucoma/Intraocular Hypertension.
Some hypnotic drugs can have an anticholinergic effect and should be used with caution in patients with glaucoma, and trouble urinating due to retention or enlarged prostate.
Immunodeficiency
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Immunodeficiency.
Stiripentol can cause a significant decline in neutrophil and platelet counts. Care should be exercised when prescribing this agent to immunosuppressed patients and those with bone marrow suppression. Hematologic testing should be obtained before starting treatment, and then every 6 months.
Liver Disease
Moderate:
Belsomra
The suvorexant in Belsomra has a moderate potential interaction with Liver Disease.
In general, anxiolytics, sedatives and hypnotics are extensively metabolized by the liver. Their plasma clearance may be decreased and their half-life prolonged in patients with impaired hepatic function. Therapy with these drugs should be administered cautiously in patients with liver disease (some are not recommended in severe liver impairment), and the dosage should be adjusted accordingly. Laboratory testing is recommended prior and during treatment.
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Liver Disease.
Stiripentol is mainly metabolized by the liver. There has been no formal study of the pharmacokinetics of stiripentol in patients with liver dysfunction. Therefore, the administration of stiripentol to patients with moderate or severe liver dysfunction is not recommended.
Malnourishment
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Malnourishment.
Stiripentol can cause decreases in appetite and weight; nausea and vomiting also occurred more often in stiripentol-treated patients. The growth of pediatric patients should be carefully monitored. In some cases, decreasing the dose of concomitant valproate by 30% per week can reduce the decrease in appetite and weight. Caution should be exercised when prescribing this agent to patients at risk.
Narcolepsy
Major:
Belsomra
The suvorexant in Belsomra has a major potential interaction with Narcolepsy.
The use of suvorexant is contraindicated in patient with narcolepsy.
Phenylketonuria
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Phenylketonuria.
Stiripentol for oral suspension contains phenylalanine, a component of aspartame. Phenylalanine can be harmful to patients with phenylketonuria (PKU). Before prescribing stiripentol for oral suspension to a patient with PKU, it is recommended to consider the combined daily amount of phenylalanine from all sources (including this product). Stiripentol capsules do not contain phenylalanine.
Psychosis
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Psychosis.
Antiepileptic drugs (AEDs) have been associated with an increased risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Pooled analyses of 199 placebo-controlled clinical studies involving the use of 11 different AEDs showed that patients receiving AEDs had approximately twice the risk of suicidal thinking or behavior compared to patients receiving placebo. AEDs should be administered cautiously in patients with depression or other psychiatric disorders; phentermine-topiramate should be avoided in patients with history of suicidal attempts or active suicidal ideation. The risk of suicidal thoughts and behavior should be carefully assessed against the risk of untreated illness, bearing in mind that epilepsy and many other conditions for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, caregivers, and families should be alert to the emergence or worsening of signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior. If patients have symptoms of suicidal ideation or behavior, a dosage reduction or treatment discontinuation should be considered.
Pulmonary Impairment
Major:
Belsomra
The suvorexant in Belsomra has a major potential interaction with Pulmonary Impairment.
Suvorexant has respiratory depressant effects and should be used with caution in patients with compromised respiratory function. Suvorexant has not been studied in patients with severe sleep apnea and severe COPD and should not be used in these patients.
Renal Dysfunction
Major:
Belsomra
The suvorexant in Belsomra has a major potential interaction with Renal Dysfunction.
Some anxiolytic, sedative and hypnotic drugs have not been studied in patients with severe renal impairment and should not be used on these patients.
Moderate:
stiripentol
Stiripentol has a moderate potential interaction with Renal Dysfunction.
Stiripentol metabolites are eliminated mainly through the kidney. There is no formal study on the pharmacokinetics and metabolism of stiripentol in patients with renal dysfunction. Therefore, the administration of stiripentol to patients with moderate or severe renal dysfunction is not recommended.
Urinary Retention
Moderate:
Belsomra
The suvorexant in Belsomra has a moderate potential interaction with Urinary Retention.
Some hypnotic drugs can have an anticholinergic effect and should be used with caution in patients with glaucoma, and trouble urinating due to retention or enlarged prostate.
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Belsomra
A total of 518 drugs are known to interact with Belsomra.
- Belsomra is in the drug class miscellaneous anxiolytics, sedatives and hypnotics.
- Belsomra is used to treat Insomnia.
stiripentol
A total of 649 drugs are known to interact with stiripentol.
- Stiripentol is in the drug class gamma-aminobutyric acid reuptake inhibitors.
- Stiripentol is used to treat Dravet Syndrome.
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
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