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. 2020 Sep 1;324(9):895–897. doi: 10.1001/jama.2020.9840

Table. Characteristics by Modafinil Exposure Status During Pregnancy in Norway (2005-2017) and Sweden (2006-2016).

Characteristics Exposed to modafinila Unexposed to modafinilb
Pregnant women, No. (%) 133 (0.007) 1 917 472 (99.993)
Maternal age, mean (SD), y 31.2 (5.0) 30.6 (5.2)
BMI prior to pregnancy
Mean (SD)c 26.4 (5.8) 24.6 (4.7)
No. (%)
<25c 52 (39.1) 909 093 (47.4)
≥25c 59 (44.4) 531 324 (27.7)
Missing 22 (16.5) 477 055 (24.9)
Smoking during early pregnancy, No. (%)
No 104 (78.2) 1 629 482 (85.0)
Yes 23 (17.3) 134 169 (7.0)
Missing 6 (4.5) 153 821 (8.0)
Maternal comorbidities, No. (%)
Multiple sclerosis (ICD-10 code G35) 29 (21.8) 2303 (0.1)
Narcolepsy (ICD-10 code G47.4) 23 (17.3) 97 (<0.1)
ADHD (ICD-10 code F90.0) 6 (4.5) 6605 (0.3)
Mental or behavioral disorderd 31 (23.3) 69 760 (3.6)
Maternal medications, No. (%)
Known teratogense 3 (2.3) 7923 (0.4)
Potential teratogensf 11 (8.3) 135 152 (7.0)
Analgesics (ATC code N02) 30 (22.6) 113 598 (5.9)
Antiepileptics (ATC code N03) 24 (18.0) 11 920 (0.6)
Psycholeptics (ATC code N05)g 21 (15.8) 58 729 (3.1)
Psychoanaleptics (ATC code N06)h 35 (26.3) 72 714 (3.8)
Multiple sclerosis treatmenti 15 (11.3) 804 (<0.1)
Infant major malformation, No. (%) 3 (2.6) 40 697 (2.1)

Abbreviations: ADHD, attention-deficit/hyperactivity disorder; ATC, Anatomical Therapeutic Chemical; BMI, body mass index; ICD-10, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

a

Defined as 1 or more filled modafinil prescriptions within the 30 days before the date of the last menstrual period to the end of the first trimester.

b

Defined as no filled modafinil prescriptions within the year prior to the date of the last menstrual period to the end of the first trimester.

c

Calculated as weight in kilograms divided by height in meters squared.

d

All ICD-10 chapter F diagnoses.

e

Includes retinoids, angiotensin-converting enzyme inhibitors, vitamin K antagonist, valproic acid, lithium, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, and methotrexate.

f

Includes danazol, progestins, methimazole, propylthiouracil, corticosteroids, and fluconazole.

g

Includes barbiturates and benzodiazepines.

h

Includes antidepressants; modafinil was excluded.

i

Includes interferon beta, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, peginterferon beta-1a, natalizumab, and fampridine.