Jane S. Ricciuti, RPh, MS


April 05, 2004

In This Article

Central Nervous System Agents

(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):

  1. Excessive sleepiness or insomnia, plus frequent episodes of impaired breathing during sleep, and associated features such as loud snoring, morning headaches, and dry mouth upon awakening; or

  2. Excessive sleepiness or insomnia and polysomnography demonstrating 1 of the following: more than 5 obstructive apneas, each greater than 10 seconds in duration, per hour of sleep and 1 or more of the following: frequent arousals from sleep associated with the apneas, bradytachycardia, and arterial oxygen desaturation in association with the apneas.

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):

  1. Either:

    1. a primary complaint of excessive sleepiness or insomnia which is temporally associated with a work period (usually night work) that occurs during the habitual sleep phase, or

    2. polysomnography and the MSLT demonstrate loss of a normal sleep-wake pattern (ie, disturbed chronobiological rhythmicity); and

  2. No other medical or mental disorder accounts for the symptoms, and

  3. The symptoms do not meet criteria for any other sleep disorder producing insomnia or excessive sleepiness (eg, time zone change [jet lag] syndrome).

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.

Provigil (Modafinil) Tablets Labeling

Provigil (Modafinil) Tablets