What is the maximum dose range for Modafinil (Provigil)?

From the Guidelines

The maximum recommended dose of modafinil is 400 mg per day, as indicated in the study by 1. The standard dosage range is 100-200 mg daily, with 200 mg being the most common effective dose for conditions like narcolepsy, obstructive sleep apnea, and shift work sleep disorder. According to the study by 1, higher doses of modafinil (200–400 mg/d) may be more effective for sleepiness, while lower doses (50–200 mg/d) seem to be better for concentration problems and fatigue. Some key points to consider when prescribing modafinil include:

• Doses exceeding 400 mg daily have not been systematically evaluated for safety or efficacy and are not recommended.
• Patients with severe hepatic impairment should reduce their dose by half (maximum 200 mg daily).
• Elderly patients may also benefit from lower starting doses due to potentially decreased clearance.
• Modafinil works by affecting neurotransmitters in the brain, particularly dopamine, to promote wakefulness without the typical side effects of traditional stimulants.
• It's essential to take modafinil early in the day to prevent sleep disturbances, and patients should be aware that exceeding recommended doses increases the risk of side effects such as headache, nausea, anxiety, and potentially serious adverse reactions including rare but serious skin rashes, as noted in the study by 1. The most frequent adverse events associated with modafinil use are headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia, as reported in the study by 1. Overall, the use of modafinil should be carefully considered, and the dosage should be individualized based on the patient's response and tolerance, as suggested by the study by 1.

From the FDA Drug Label

Although these studies showed statistically significant differences favoring modafinil over placebo in reducing ADHD symptoms as measured by the ADHD-RS (school version), there were 3 cases of serious rash including one case of possible SJS among 933 patients exposed to modafinil in this program. 8. 5 Geriatric Use In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging Therefore, consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration (2.4)and Clinical Pharmacology (12.3)]. 8.6 Hepatic Impairment In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Dosage and Administration (2. 3) and Clinical Pharmacology (12.3)].

The maximum dose range for modafinil is not explicitly stated in the provided drug labels. However, it is mentioned that in clinical trials, doses ranging from 1,000 to 1,600 mg/day (5 to 8 times the recommended daily dose) have been administered to 32 subjects, and intentional acute overdoses of up to 4,500 mg have been reported.

• Key points:
  • The recommended daily dose is not specified in the provided text.
  • Doses up to 1,600 mg/day have been administered in clinical trials.
  • Intentional acute overdoses of up to 4,500 mg have been reported. Based on the information provided, no conclusion can be drawn about the maximum dose range for modafinil, as the recommended daily dose is not specified 2.

From the Research

Maximum Dose Range for Modafinil

The maximum dose range for modafinil is as follows:

• The recommended dosage of modafinil is 200 or 400 mg/day, given once or twice daily (morning and midday) to patients with narcolepsy 3
• Studies have shown that modafinil is well tolerated in patients with narcolepsy at doses of 200 to 400 mg/day 3
• The pharmacokinetics of modafinil were linear and dose dependent over the dose range 200 to 600mg 3
• However, the incidence or severity of adverse events associated with the use of modafinil did not appear to be dose related 3

Key Points

• Modafinil is effective in the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy 3
• Modafinil has a low abuse potential and is not associated with withdrawal phenomena 3
• The mechanism of action of modafinil has not been clearly established, but it may indirectly increase wakefulness through inhibition of cortical γ-aminobutyric acid (GABA) release via serotonergic mechanisms 3
• Armodafinil, the R-enantiomer of modafinil, has a longer half-life and may be preferred by patients with excessive sleepiness due to its longer duration of effect 4, 5, 6, 7