"The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder ("non-24") in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorde"...
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of NUVIGIL in long-term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe NUVIGIL for an extended time in patients should periodically re-evaluate long-term usefulness for the individual patient.
DOSAGE AND ADMINISTRATION
Obstructive Sleep Apnea (OSA) and Narcolepsy
The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg to 250 mg given once daily in the morning. In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose [see CLINICAL PHARMACOLOGY and Clinical Studies].
Shift Work Disorder (SWD)
The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift. [see Clinical Studies]
Use in Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients. [see Use In Specific Populations]
Dosage Forms And Strengths
- 50 mg - round, white to off-white tablet with EH on one side and “205” on the other
- 150 mg - oval, white to off-white tablet with HD on one side and “215” on the other
- 200 mg - rounded, rectangular, white to off-white tablet with CU on one side and “220” on the other
- 250 mg - oval, white to off-white tablet with HD on one side and “225” on the other
Storage And Handling
NUVIGIL® (armodafinil) Tablets are available as follows:
50 mg: Each round, white to off-white tablet is debossed with on one side and “205” on the other.
NDC 63459-205-30 - Bottles of 30
150 mg: Each oval, white to off-white tablet is debossed with na on one side and “215” on the other.
NDC 63459-215-30 - Bottles of 30
200 mg: Each rounded, rectangular, white to off-white tablet is debossed with on one side and “220” on the other.
NDC 63459-220-30 - Bottles of 30
250 mg: Each oval, white to off-white tablet is debossed with HE on one side and “225” on the other.
NDC 63459-225-30 - Bottles of 30
Store at 20°- 25°C (68°- 77°F).
Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised June 2013
Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.
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