Summary of Use during Lactation

Armodafinil is the R-enantiomer of modafinil. The amount of armodafinil in one nursing mother was very low. Minimal information from women who breastfed their infant's while using racemic modafinil found no adverse effects in their infants. Until more safety data are available, armodafinil should be used with careful infant monitoring during breastfeeding, or an alternate drug may be preferred.

Drug Levels

Maternal Levels. A woman with idiopathic hypersomnolence was treated with armodafinil 250 mg daily. She was also taking 75 mcg of levothyroxine daily for Hashimoto's thyroiditis, sertraline 200 mg daily for obsessive-compulsive and major depressive disorders, and inhaled albuterol as needed for mild intermittent asthma. At 19 days postpartum, milk samples were collected at 0, 1, 2, 4, 6, 8, 10, 12, and 24 hours after the dose. The trough milk armodafinil level was 0.43 mg/L, with peak value of 2.3 mg/L at 2 hours after the dose. Based on the average amount in milk of 1.2 mg/L, the daily infant dosage was estimated to be 0.18 mg/kg, which corresponded to a weight-adjusted infant dosage of 5.3% of the maternal dosage.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In one case-control study of women having narcolepsy with cataplexy, some women (fewer than 6) breastfed their infants while taking modafinil. No adverse effects were noted. The authors felt that the risk from the medication is low.[2]

Effects on Lactation and Breastmilk

A case control study comparing women with narcolepsy with cataplexy to a control group found that those with narcolepsy breastfed longer than those without the disease. The authors felt that the difference likely due to a lower employment rate among the women with narcolepsy.[2]

Alternate Drugs to Consider

(Narcolepsy) Amphetamine, Dextroamphetamine, Lisdexamfetamine, Methylphenidate, Modafinil

References

1.

Aurora S, Aurora N, Datta P et al. Evaluating transfer of modafinil into human milk during lactation: A case report. J Clin Sleep Med. 2018;14:2087-9. [PMC free article: PMC6287734] [PubMed: 30518447]

2.

Calvo-Ferrandiz E, Peraita-Adrados R. Narcolepsy with cataplexy and pregnancy: A case-control study. J Sleep Res. 2018;27:268-72. [PubMed: 28568319]

Substance Name

Armodafinil

CAS Registry Number

112111-43-0

Drug Class

• Breast Feeding
• Lactation
• Central Nervous System Stimulants
• Wakefulness-Promoting Agents