"The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
Belsomra is an orexin receptor antagonist and is the first approved drug of t"...
Limitations of Use
In OSA, PROVIGIL 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 and during treatment with PROVIGIL for excessive sleepiness.
DOSAGE AND ADMINISTRATION
Dosage In Narcolepsy And Obstructive Sleep Apnea (OSA)
The recommended dosage of PROVIGIL for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose [see CLINICAL PHARMACOLOGY and Clinical Studies].
Dosage In Shift Work Disorder (SWD)
The recommended dosage of PROVIGIL for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
Dosage Modifications In Patients With Severe Hepatic Impairment
In patients with severe hepatic impairment, the dosage of PROVIGIL should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
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
- 100 mg – capsule-shaped, white to off white, tablet, debossed with “PROVIGIL” on one side and “100 MG” on the other.
- 200 mg – capsule-shaped, white to off white, scored, tablet, debossed with “PROVIGIL” on one side and “200 MG” on the other.
Storage And Handling
PROVIGIL® (modafinil) tablets are available as follows:
100 mg: Each capsule-shaped, white to off white tablet is debossed with “PROVIGIL” on one side and “100 MG” on the other. NDC 63459-101-30 – Bottles of 30
200 mg: Each capsule-shaped, white to off white, scored tablet is debossed with “PROVIGIL” on one side and “200 MG” on the other. NDC 63459-201-30 – Bottles of 30
Store at 20°-25°C (68°-77°F).
Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised January 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/29/2015
Additional Provigil Information
Provigil - User Reviews
Provigil User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips for better sleep.