Central Nervous System AgentsProvigil (Modafinil) Tablets
Manufacturer: Cephalon, Inc.
Drug Approval Classification: Supplemental New Drug Application (Approval Date: 1/23/04)
New Indication: This supplemental approval provides for the use of Provigil (modafinil) tablets to improve wakefulness in 2 new patient populations with excessive sleepiness: those with obstructive sleep apnea/hypopnea syndrome (OSAHS) and those with shift work sleep disorder (SWSD).
Dosing: The recommended dose of modafinil is 200 mg given once a day. For patients with SWSD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Clinical Summary: Two clinical studies evaluated the efficacy of modafinil in the treatment of OSAHS. More than 400 eligible patients were included who met the International Classification of Sleep Disorders (ICSD) criteria for OSAHS (DSM-IV criteria):
Modafinil 200 and 400 mg/day resulted in improvements in baseline sleep latency and ability to remain awake of 1.6 and 1.5, respectively.
In SWSD, modafinil was studied in a 12-week placebo-controlled clinical trial in 209 patients who met the criteria for chronic SWSD (DSM-IV criteria for Circadian Rhythm Sleep Disorder: Shift Work Type):
Patients treated with modafinil showed a statistically significant prolongation in the time to sleep onset compared with placebo-treated patients.
Adverse Effects: Most common adverse events associated with the use of modafinil were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.
Medscape Pharmacists. 2004;5(1) © 2004 Medscape
Cite this: March 2004 - Medscape - Apr 06, 2004.