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Narcolepsy Clinical criteria: Treatment Phase: Initial 1 - treatment of narcolepsy without cataplexy Treatment criteria: Must be treated by a qualified sleep medicine practitioner or neurologist. The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal, AND Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months, AND Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep, AND Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia. The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk: (a) a psychiatric disorder; (b) a cardiovascular disorder; (c) a history of substance abuse; (d) glaucoma; (e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information. The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration. The authority application must be made in writing and must include the following: (a) a completed authority prescription form; and (b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and (c) details of the contraindication or intolerance to dexamfetamine sulfate; and (d) either: (i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or (ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist. The polysomnography, MSLT or EEG test reports must be provided with the authority application.
“The precise mechanism(s) through which modafinil promotes wakefulness is unknown.”
“The elimination half-life of modafinil after multiple doses is about 10-12 hours.”
“In vitro studies with human hepatocytes and liver microsomes have shown induction of metabolising enzymes CYP3A4 and CYP1A1/2, and inhibition of CYP2C19 (see Section 4.5 "INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS").”
Working under the parallel aged-care framework? Aged-care equivalent →
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.