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Policy Name: Provigil
Policy Number: 030501
Origination Date: 01/05/03
Review / Revision Date: 01/27/04, 3/25/04, 09/01/04, 6/21/06
Current OK policy
Origination Date: 01/05/03
Review / Revision Date: 01/27/04, 3/25/04, 09/01/04, 06/21/06 |
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Modafinil (Provigil) is considered medically necessary for the treatment of:
-Excessive daytime sleepiness associated with narcolepsy
-Severe fatigue associated with multiple sclerosis
-Residual excessive daytime sleepiness associated with obstructive sleep apnea/hypopnea when all of the following criteria are met:
A. Documentation that the patient has been on CPAP for at least 2 months and is using it on average of at least 4 hours per night.
B. The patient has an Epworth Sleepiness Scale score of greater than 10-despite treatment with
CPAP.
-Excessive sleepiness associated with the diagnosis of shift work sleep disorder when all of the following criteria are met:
A. There is a primary complaint of excessive sleepiness or insomnia, which is associated with a work period (usually night work) that occurs during the habitual sleep phase and all of the following:
1. Epworth Sleepiness Scale score of greater than 10
2. Polysomnography and MSLT demonstrate loss of a normal sleep – wake pattern (disturbed chronobiological rhythmicity)
B. No other medical or mental disorder accounts for the symptoms
C. The symptoms do not meet criteria for any other sleep disorder producing insomnia or excessive sleepiness (e.g. time zone changes [jet lag] syndrome). |
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Modafinil (Provigil)is a wakefulness-promoting agent for oral administration. The precise mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions like sympathomimetic agents including amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of sympathomimetic amines. The primary sites of modafinil's CNS activity appear to be in the subregions of the hippocampus, the centrolateral nucleus of the thalamus, and the central nucleus of the amygdala. In contrast to the amphetamines and other CNS stimulants, the effects of modafinil do not appear to be mediated by dopamine or sympathomimetic systems. In vitro and in vivo studies demonstrate that modafinil does not bind to most of the neurochemical receptors involved in sleep-wake cycles, including norepinephrine, serotonin, dopamine, GABA, adenosine, histamine, monoamine oxidase B, and benzodiazepines. Modafinil also does not alter hormones associated with sleep regulation (i.e., melatonin, cortisol, or growth hormone). Modafinil-induced wakefulness does not influence nocturnal sleep patterns or the incidence of cataplexy in narcoleptic patients. In the periphery, the actions of modafinil appear to be minimal at normally prescribed doses.
Modafinil (Provigil) dosing:
For the treatment of narcolepsy or for the adjunctive treatment of excessive daytime sleepiness associated with Parkinson's disease or obstructive sleep apnea (despite the use of CPAP), or due to sleep problems resulting from circadian rhythm disruption (i.e., shift-work sleep disorder):
Oral dosage:
Adults and adolescents >= 16 years: 200 mg PO once daily in the morning
Elderly: Initially, 100 mg PO once daily in the morning. As the patient's clinical response dictates, dosage may be increased to 200 mg PO once daily in the morning, if needed.
Adolescents and children < 16 years: Safe and effective use has not been established.
Common adverse events include headache, nausea, vomiting, diarrhea, rhinitis, nervousness, dizziness, dry mouth, depression, anxiety, insomnia, hypotension, and dyspnea.
More serious adverse events include arrhythmias, syncope, visual changes, abuse/dependency.
Modafinil is pregnancy category C. |
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Provigil ® (Modafinil) Prescribing Information
Schwartz JR, Feldman NT, Bogan RK, Nelson MT, Hughes RJ. Dosing regimen effects of modafinil for improving daytime wakefulness in patients with narcolepsy.
Clin Neuropharmacol. 2003 Sep-Oct; 26(5): 252-7.
Black JE, Hirshkowitz M. Modafinil for treatment of residual excessive sleepiness in nasal continuous positive airway pressure-treated obstructive sleep apnea/hypopnea syndrome.
Sleep. 2005 Apr 1; 28(4): 464-71.
Keating GM, Raffin MJ. Modafinil: a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder.
CNS Drugs. 2005; 19(9): 785-803. Review.
Zifko UA, Rupp M, Schwarz S, Zipko HT, Maida EM. Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.
J Neurol. 2002 Aug; 249(8): 983-7.
Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study.
Neurology. 2005 Apr 12; 64(7): 1139-43.
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