Q:        I understand that modafanil/armodafanil interfere with oral contraception, which makes sense in terms of metabolism.  However, I am puzzled regarding the caution for use with IUDs that emit hormones.  How much should we be concerned about this interactions?

A:       

While I see a note about a possible effect of this drug on the effectiveness of combined pills, it is not among the drugs listed that reduce pills effectiveness (in the Medical Eligibility Criteria published by the CDC an World Health Organization.
It
should have no effect on an progestin-elaborating IUD such as Mirena.

 In 1998, modafinal was approved by the U.S. Food and Drug Administration[6] for the treatment of narcolepsy and in 2003 for shift work sleep disorder and obstructive sleep apnea/hypopnea[7] even though caffeine and amphetamine were shown to be more wakefulness promoting on the Stanford Sleepiness Test Score than modafinil.[8] EEG studies indicate caffeine, amphetamine, and modafinil to all be theta wave reducing but only modafinil to be Alpha wave promoting during wakefulness as well as theta wave increasing during sleep.[9]

Approval for attention deficit hyperactivity disorder (ADHD) in children was rejected in 2006 due primarily to two cases of skin rash, one severe, suspected to have been erythema multiforme or Stevens–Johnson syndrome, among 933 subjects receiving the drug.[10][11][12][13] Cephalon’s own label for Provigil now discourages its use by children for any purpose.[14] In some countries, it is also approved for other hypersomnias, like idiopathic hypersomnia. The usual prescribed dosage for these disorders is 200 mg once a day (less commonly, 100 to 400 mg/day in one or two doses). Modafinil has also been linked in many articles to increasing concentration.[citation needed]

For conditions other than shift work sleep disorder, modafinil is normally taken in one dose in the morning or in two doses in the morning and at midday. It is generally not recommended to take modafinil after noon: modafinil is a relatively long-acting drug with a half-life of 15 hours, and taking it during the later part of the day carries a risk of sleep disturbances.[15][unreliable medical source?]

Because of the risk for development of skin or hypersensitivity reactions and neuropsychiatric disorders, the European Medicines Agency has recommended that new patient prescriptions should only be to treat sleepiness associated with narcolepsy.[16] Because any serious side effects will usually appear within the first twelve weeks, the guidance does not require patients already receiving treatment to stop taking the drug.[17]

 

Robert A. Hatcher MD, MPH

Emeritus Professor of Gynecology and Obstetrics

Emory University School of Medicine

Atlanta, GA

To learn more about the advantages and disadvantages of oral contraceptive pills and Mirena IUD, go to: www.managingcontraception.com .  You can order all of the books listed below from our website or by calling 404-875-5001.  

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Key Words:  Modafanil/Armodafanil, interfere, oral contraceptives, metabolism, caution, IUDs, hormones, interaction, U.S. Food and Drug Administration, narcolepsy, sleep disorder, apnea, caffeine, amphetamine, wakefulness, Alpha, deficit hyperactivity disorder (ADHD), children, severe, Stevens-Johnson syndrome, Provigil, shift work, risk, development of skin, reactions, neropsychiatric disorders, European Medicines Agency, side-effects, combined pills, Medical Eligibility Criteria, CDC, World Health Organization, Mirena IUD 

 

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