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Revisión médica por Fedorchenko Olga Valeryevna Última actualización de farmacia el 30.03.2022
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Limitations Of Use
Somsanit may only be dispensed to patients enrolled in the Somsanit REMS Program.
Cataplexy In Narcolepsy
Somsanit (sodium oxybate) oral solution is indicated for the treatment of cataplexy in narcolepsy.
Excessive Daytime Sleepiness In Narcolepsy
Somsanit (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness (EDS) in narcolepsy.
Healthcare professionals who prescribe Somsanit must enroll in the Somsanit REMS Program and must comply with the requirements to ensure safe use of Somsanit.
Dosing Information
The recommended starting dose is 4.5 grams (g) per night administered orally in two equal, divided doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dose by 1.5 g per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later) to the effective dose range of 6 g to 9 g per night orally. Doses higher than 9 g per night have not been studied and should not ordinarily be administered.
Table 1: Somsanit Dose Regimen (g = grams)
If A Patient’s Total Nightly Dose is: | Take at Bedtime: | Take 2.5 to 4 Hours Later: |
4.5 g per night | 2.25 g | 2.25 g |
6 g per night | 3 g | 3 g |
7.5 g per night | 3.75 g | 3.75 g |
9 g per night | 4.5 g | 4.5 g |
Important Administration Instructions
Take the first dose of Somsanit at least 2 hours after eating because food significantly reduces the bioavailability of sodium oxybate.
Prepare both doses of Somsanit prior to bedtime. Prior to ingestion, each dose of Somsanit should be diluted with approximately ¼ cup (approximately 60 mL) of water in the empty pharmacy vials provided. Patients should take both doses of Somsanit while in bed and lie down immediately after dosing as Somsanit may cause them to fall asleep abruptly without first feeling drowsy. Patients will often fall asleep within 5 minutes of taking Somsanit, and will usually fall asleep within 15 minutes, though the time it takes any individual patient to fall asleep may vary from night to night. Patients should remain in bed following ingestion of the first and second doses, and should not take the second dose until 2.5 to 4 hours after the first dose. Patients may need to set an alarm to awaken for the second dose. Rarely, patients may take up to 2 hours to fall asleep.
Dose Modification In Patients With Hepatic Impairment
The recommended starting dose in patients with hepatic impairment is 2.25 g per night administered orally in two equal, divided doses: approximately 1.13 g at bedtime and approximately 1.13 g taken 2.5 to 4 hours later.
Dose Adjustment With Co-Administration Of Divalproex Sodium
Pharmacokinetic and pharmacodynamic interactions have been observed when Somsanit is co-administered with divalproex sodium. For patients already stabilized on Somsanit, it is recommended that addition of divalproex sodium should be accompanied by an initial reduction in the nightly dose of Somsanit by at least 20%. For patients already taking divalproex sodium, it is recommended that prescribers use a lower starting Somsanit dose when introducing Somsanit. Prescribers should monitor patient response and adjust dose accordingly.
- Somsanit is contraindicated in patients being treated with sedative hypnotic agents.
- Patients should not drink alcohol when using Somsanit.
- Somsanit is contraindicated in patients with succinic semialdehyde dehydrogenase deficiency. This is a rare disorder of inborn error of metabolism variably characterized by mental retardation, hypotonia, and ataxia.