What Is The Best Dose For Provigil (Modafanil)?

Dosing depends on what it is being used for.

Question

I'm taking 100mg of Provigil twice a day, as well as prescribed to take 2mg of alprazolam ER twice daily. Additionally I am taking Effexor XR, topiramate and tizanidine as needed (most days I only take this at night with 100mg trazodone). My question is the doctor just added the additional second dose of Provigil. However I'm finding the morning dose doesn't seem to help with my tiredness. My doctor has prescribed the Provigil for my fibromyalgia, depression and excessive daytime sleeping. It has improved all of these things and is helping regulate my sleep cycle. However the mornings are still very rough. Do you think that the morning dose needs to be increased?

Asked by Kat On Dec 01, 2018

Answered by
Medical Content Reviewed By PharmacistAnswers Staff

On Dec 04, 2018

Answer

There are many factors that could be contributing to your daytime sleepiness so it's difficult to give guidance regarding an appropriate dose of Provigil (modafinil) for your particular medical situation.

Many of the medications you are currently taking are very much associated with sedation and lethargy, notably your alprazolam and topiramate. These medications, in addition to conditions you may be treating (e.g. major depressive disorder), could all be contributing to your symptoms.

In terms of dosing for Provigil, guidance is given in the prescribing information for the FDA approved indications of sleep apnea, narcolepsy and shift work sleep disorder. The recommended dose is:

  • 200 mg once daily as a single dose in the morning.

Additionally, the prescribing information states that 400 mg may be used, but doses above 200 mg may not confer any benefit:

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 dose
Provigil Prescribing Information

It seems that you are using Provigil for an 'off-label' indication, as an adjunct treatment of symptoms (e.g., fatigue, sleepiness) associated with a medical condition like major depression.

Several studies (Study 1, Study 2) have evaluated Provigil used in this manner, and it does seem to be effective for the majority of individuals, but only for a short period of time.

Dosing for off-label uses in studies generally starts at:

  • 100 mg/day initially, followed by titration up to a maximum of 400 mg/day based upon tolerability and response.

In both studies linked above, Provigil did improve fatigue and wakefulness compared to placebo. However, effects tended to wear off after a few weeks, and by week 6 in one study, Provigil was no more effective than placebo.

From Study 2, which evaluated Provigil as an adjunct treatment of fatigue associated with major depressive disorder:

Modafinil [Provigil] rapidly improved fatigue and daytime wakefulness, with significantly greater mean improvements from baseline than placebo in fatigue (FSS) [Fatigue Severity Scale] scores at week 2 (p < .05) and sleepiness (ESS) [Epworth Sleepiness Scale] scores at week 1 (p < .01); the differences between modafinil and placebo at week 6 were not statistically significant.

The FDA-approved maximum daily dose of Provigil is 400 mg. You should speak with your doctor regarding your dosing and whether or not it would be safe and potentially effective to increase your dose.

Section Summary

For FDA approved indications, dosing generally starts at 200 mg as a single dose in the morning. For most off-label indications (e.g. adjunct for symptoms associated with major depressive disorder), dosing starts 100 mg as a single dose, and increased based on efficacy and tolerability.

Final Words

Based on all the available data, Provigil may be beneficial in the short term, but if you are using it as an 'add-on' treatment for symptoms brought on by depression, it may only be temporarily effective.

Additionally, as mentioned above, your current medication list could potentially be a causative factor in the sedative effects you are feeling throughout the day.

About the Pharmacist

Dr. Brian Staiger Pharm.D

Dr. Brian Staiger is a licensed pharmacist in New York State and the founder of PharmacistAnswers.com. He graduated from the University At Buffalo with a Doctor Of Pharmacy degree in 2010. He has been featured in several publications including the Huffington Post as well as a variety of health and pharmacy related blogs. Please feel free to reach out to him directly if you have any questions or want to connect! [email protected]rmacistAnswers.com; Office: 716-389-3076

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