For professionals

Clinician support for pregnancy and safe baby care

for all parents with idiopathic hypersomnia or narcolepsy type 1 or 2

We developed this page with the advice of OB/GYN, maternal fetal medicine, pediatrics, lactation, and sleep medicine experts.

Many person(s) with hypersomnias (PWH) are able to handle the challenges of parenting, but for others the severity of symptoms may make parenting extra difficult or impossible. You can help PWH consider important factors when deciding about parenting, pregnancy, adoption, or nursing.

Refer your patients to our patient-facing web page about pregnancy and safe baby care.

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Can a child inherit a hypersomnia sleep disorder?

The evidence is mixed. Inheritance patterns are complex, and the genetics of idiopathic hypersomnia (IH) and narcolepsy type 1 and 2 (NT1 and NT2) aren’t well understood. 

Since sleepiness and prolonged sleep seem to be at least partially familial, people with IH, NT1, and NT2 may be more likely to have children with other sleep disorders. The details aren’t yet known (Daly, 1959; Masri, 2012; Mayer, 1998; Nevšímalová, 1997).

Idiopathic hypersomnia 

Familial frequency and inheritance patterns, if any, are largely unknown. However, limited studies report that about one third of people with IH have a family member with similar symptoms, suggesting a genetic component (Bassetti, 1997; Anderson, 2007; Ali, 2009; Vernet, 2010). 

Narcolepsy type 1

Family studies including hundreds of people with narcolepsy with cataplexy (NT1) show it’s rare for family members to also have NT1. Experts believe the typical chance of passing it to a baby is quite low at 1-5%. (See related slides from Dr. Arnulf’s 2018 conference presentation.) 

However:

  • Risk may be much higher in specific populations, such as people of Czech, German, Hong Kong, or Japanese descent (Guilleminault, 1989; Mayer, 1998; Nevšímalová, 1997; Wing, 2011; Yamasaki, 2016). This is likely related to HLA inheritance since some of these variants are known to predispose to NT1. 
  • Risk may also be much higher in families with more than one person with NT1 (Ohayon, 2019). 

Narcolepsy type 2

Although some of the above narcolepsy studies included some people with NT2, the specific genetics of NT2 aren’t yet known.

Will pregnancy worsen hypersomnia symptoms?

Some people who have idiopathic hypersomnia or narcolepsy type 1 or 2 feel better during pregnancy. Others feel worse than usual. These changes may be related to hormones and may also vary by trimester. If you and the PWH decide to stop their hypersomnia medicines or lower their doses due to pregnancy, this may also worsen their symptoms. PWH whose symptoms become too debilitating due to pregnancy-related changes may need your help getting work or school accommodations or medical leave (such as FMLA and short-term disability).

You can refer them to our web pages:

When should medicines be continued or stopped during pregnancy? 

Only the PWH, with the advice of their doctors, can decide if the risks of continuing medicines during pregnancy outweigh the risks of stopping the medicines. Use shared decision making when working with PWH to decide about continuing or stopping medicines (see this journal article “Model for Clinical Practice)”. If teratogenic effects happen, they’re most likely in early pregnancy during organogenesis (as organs are forming). For this reason, it’s ideal for you and the PWH together to carefully review their medicines before they try to conceive.

In general, medicines should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus. Unfortunately, scientists currently know little about the teratogenic effects of many medicines commonly used to treat hypersomnias. Until they know more, the most reliable option is to avoid these medicines, especially during the first trimester. However, for some people, completely stopping one or more medicines may not be acceptable, especially in cases of sleep disorders. 

Stopping their medicines may lead to many significant risks, including:

  • Worse symptoms
  • Depression
  • Lower ability to drive 
  • Lower ability to work

Pregnancy registries help define risks of continuing medicines

If a PWH in your care continues medicines during pregnancy, consider reporting this to pregnancy registries, as this provides valuable information to help future pregnancies. Registries help researchers make recommendations for using or stopping medicines during conception and pregnancy by comparing rates of birth defects. The rate of birth defects is about 3% in the general population. Registries collect data to help determine if the likelihood of birth defects is higher when the pregnant person is taking specific medicines. For more information, see the U.S. FDA’s web page “Pregnancy Exposure Registries” and the pregnancy risk profiles for hypersomnia medicines below.

What are the pregnancy risk profiles of medicines used to treat hypersomnia sleep disorders?

  • Consider advising pregnant people exposed to amphetamines to enroll in the National Pregnancy Registry for Psychiatric Medications (1-866-961-2388).
  • The U.S. FDA label states that dextroamphetamine “should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.” 
  • Studies in non-human animals are mixed, with some showing embryotoxic effects at doses much higher than those used for humans. 
  • Overall, human studies show low risk. 
    • In a study pooling millions of U.S. and Nordic pregnancies, researchers didn’t find higher risks for any birth defects with prescription amphetamine use (Huybrechts, 2018; also see the Reuters article about this study.)
    • In a large study of early pregnancy, ADHD medicine use was associated with 3 of 12 selected birth defects — gastroschisis (odds ratio 2.9), omphalocele (odds ratio 4.0), and transverse limb deficiency (odds ratio 3.3) (Anderson, 2018; see also the CDC’s summary article). It’s important to remember that even with the small increases in relative risk seen in these studies, the absolute risk of these birth defects is still very low. 
    • “Psychostimulant use during pregnancy was associated with a small increased relative risk of preeclampsia and preterm birth. The absolute increases in risks are small and, thus, women with significant ADHD should not be counseled to suspend their ADHD treatment based on these findings” (Cohen, 2017). 
    • A prospective study of 237 exposed pregnancies found a small lowering of birth weight among pregnant people who continued to use their prescribed dextroamphetamine past 28 weeks (Naeye, 1983). A retrospective cohort study of 53 exposed pregnancies found no effects of amphetamines on birth weight (Rose, 2021).
    • Although those who misuse amphetamines may have babies born with withdrawal symptoms such as jitteriness, sleepiness, and trouble breathing, this has not been reported in people who are taking dextroamphetamine as prescribed. 
    • Read more at MotherToBaby.org.
  • Consider advising pregnant people exposed to antidepressants to enroll in the National Pregnancy Registry for Psychiatric Medications (1-866-961-2388).
  • If a PWH is taking these medicines primarily for depression (and not for cataplexy or excessive daytime sleepiness [EDS]), keep in mind that psychotherapy is also an effective treatment for mild to moderate depression and may be able to help reduce the need for antidepressants. 

SSRIs/SNRIs (such as Prozac/Effexor)

Clomipramine (such as Anafranil)

  • Large human studies show no significant increased risk for birth defects or abnormal fetal growth. A smaller study showed a possible link with increased risk of heart defects in the baby, but the absolute risk is very low. (Read more at Bumps: Best Use of Medicines in Pregnancy.) 
  • The dose used to treat cataplexy (10-50 mg) is significantly lower than that used to treat depression (75-150 mg), which may help to reduce any risks.

Newborn withdrawal from antidepressants

Although newborns may experience withdrawal symptoms from antidepressants (including both clomipramine and SSRIs/SNRIs), there’s no evidence that tapering off these medicines in the 3rd trimester improves infant outcomes. Also, stopping antidepressants risks precipitating a depression relapse or postpartum depression, particularly in high-risk individuals. And if these medicines are being used to treat cataplexy or EDS, those symptoms will likely worsen when stopping treatment. If antidepressants are used continuously through delivery, the newborn should be monitored closely and may need to spend a few extra days in a neonatal unit or a “kangaroo unit” (Byatt et al, 2012).

  • The U.S. FDA label states that clarithromycin should only be used in pregnancy when “no alternative therapy is appropriate.” 
  • Studies in non-human animals show increased birth defects. 
  • However, the studies on clarithromycin and human birth defects have overall been reassuring (Clarithromycin Lexicomp, 2020). 
  • A very large 2021 study showed a small possible risk for AVSD (cardiac atrioventricular septal defect) and possibly a small association with orofacial clefts (but that would require further testing to conclude) (Leke, 2021).
  • Although the risk for congenital anomalies overall seems quite low, the risk for fetal loss within the first 12 to 14 weeks of pregnancy is consistently elevated across studies. Therefore, one may consider stopping clarithromycin during this time period, which is also the time for organogenesis. 
  • It is important to note these recommendations pertain to clarithromycin use as a short-course antibiotic. Presumably the risks could be greater for the off-label long-term use of higher doses (500 to 1000 mg twice daily) to treat hypersomnias. Also, one may need to consider clarithromycin’s effects on microbial flora, especially when used long-term.
  • Consider advising pregnant people exposed to methylphenidates to enroll in the National Pregnancy Registry for Psychiatric Medications (1-866-961-2388).
  • The U.S. FDA label states that methylphenidate “should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.” 
  • Studies in non-human animals show no increase in birth defects. 
  • Overall, human studies show low risks.
    • One large study suggests a possible small increase in cardiac malformations in babies born to pregnant people taking methylphenidate (Huybrechts, 2018; also see the Reuters article about this study.) 
    • Another large study suggests a possible small increase in other types of birth defects: omphalocele, gastroschisis, and transverse limb deficiency (Anderson, 2018; see also the CDC’s summary article). It is important to remember that even with the small increases in relative risk seen in these studies, there is an even lower absolute risk of these birth defects. 
    • Also, a 2020 Danish study showed no increase in risk with methylphenidate in nearly 1000 first-trimester exposures (Damkier, 2020). 
    • There may be a higher risk of miscarriage associated with methylphenidate, but it’s not clear if this risk is instead associated with the mother’s ADHD diagnosis (Haervig, 2014; Diav-Citrin, 2016). 
  • When taken as prescribed, use of methylphenidate has not shown a risk of newborn withdrawal.
  • Read more at MothertoBaby.org.
  • Consider advising pregnant people exposed to modafinil/armodafinil to enroll in the Provigil or Nuvigil Pregnancy Registries (1-866-404-4106). They can also enroll in the National Pregnancy Registry for Psychiatric Medications (1-866-961-2388).
  • European and Canadian regulators recommend that modafinil/armodafinil should not be used during pregnancy: see Health Canada safety information for Modafinil; 2019 EMA PRAC Recommendations; U.S. FDA label for Modafinil (see section 8 Use in Specific Populations). 
  • Studies in non-human animals show an increase in birth defects. 
  • Overall, human studies indicate that there appears to be a significant increase in risk of birth defects from use of modafinil/armodafinil.
    • A Danish study of 49 human pregnancies exposed to modafinil in the first trimester showed a greater than 3-fold increased risk of major birth defects (Damkier et al, 2020).
    • A study of nearly 150 pregnancies exposed to modafinil/armodafinil in the first trimester, based on the U.S. pregnancy registry, indicates a 13% risk of major congenital malformations. In contrast, the prevalence of major congenital malformations in the general population is roughly 3%; therefore, this 13% risk is a greater than 4-fold increase in risk (Kaplan et al, 2020). 
    • A study of 131 Norwegian and Swedish pregnancies exposed to modafinil in the first trimester showed no significant increase in major malformations; however, because modafinil use is so rare, the confidence intervals allow for the possibility of the greater than 3-fold risk as previously reported (Cesta et al, 2020).
    • See also Massachusetts General Hospital’s Reproductive Psychiatry Resource Center.
  • You may report pregnancy complications to the Xyrem and Xywav REMS Program (1-866–997-3688) or the Lumryz REMS program (1-877-453-1029). However, there aren’t actual pregnancy registries for these medicines.
  • Studies of sodium oxybate in non-human animals report an increased incidence of early miscarriage, increased stillbirths, increased number of deaths in baby rats once born, and decreased growth rates in those baby rats that survived. 
  • There are no well-controlled studies in humans, but it appears that exposure to sodium oxybate during the first trimester may be associated with an increased risk of fetal loss. (See Drugs.com’s “Can you take Xyrem while pregnant?” and section 8 of the U.S. FDA label for sodium oxybate.) 
  • Limited data from pregnant people during their second and third trimesters did not indicate fetal/neonatal toxicity of this sodium oxybate (European Medicines Agency’s Xyrem Summary 2022).
  • A 2018 study of long-term sodium oxybate use showed that 5 women who became pregnant while on it, with subsequent discontinuation, delivered healthy babies (Mayer, 2018). 
  • The indication itself (severe sleepiness and cataplexy) suggests that the benefit to the pregnant person, “under close medical supervision, may outweigh the unknown risk to the embryo-fetus” (Sodium Oxybate Briggs Drugs 2017).
  • Consider advising pregnant people exposed to pitolisant to enroll in the Wakix Pregnancy Registry (1-877-302-2813).
  • According to the U.S. FDA label, “Available case reports from clinical trials and postmarketing reports with . . . use in pregnant women have not determined a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
  • Studies in non-human animals show an increase in birth defects. 
  • There are no well-controlled studies in humans.
  • Consider advising pregnant people exposed to solriamfetol to enroll in the Sunosi Pregnancy Registry (1-877-283-6220).
  • The U.S. FDA label states that available data is not yet sufficient to determine human risk. 
  • Studies in non-human animals showed birth defects only at doses substantially higher than the equivalent human dose.

While trying to conceive, PWH can take medicines during their menstrual “safety zone” without risk to the fetus

If you and a PWH together decide to try to stop one or more of their medicines while they are pregnant, then you will also want to consider stopping the medicines while they try to conceive. It takes 6 months on average to become pregnant, and it can be difficult to give up medicines completely during the months or years it can take to become pregnant. 

Medicines in the blood of the pregnant person do not pass to the embryo until it is implanted on the wall of the uterus. Therefore, instead of stopping medicines completely, a PWH can take them during the safety zone when there is very low risk to a potential pregnancy. The safety zone is the first day of menstruation until the day before possible egg implantation in the uterus. Within the safety zone, the embryo should not be exposed to medicine. Each medicine must be eliminated before implantation and therefore has its own safety zone based on its half-life.

The tables below show the days to elimination and safety zone for common hypersomnia medicines with varying half-lives given the following assumptions:

  • Medicine elimination is sufficiently complete after 5 half-lives have passed.
  • The PWH has a regular 28-day cycle with ovulation on Day 14. Day 1 of the cycle is the first day of menstruation. If their cycle is longer, or if temperature tracking shows ovulation is later than Day 14, you may extend the safety zone by a few more days. If their cycle is shorter, or ovulation is earlier, you must shorten the safety zone.
  • It usually takes 8 days from ovulation for a fertilized embryo to implant in the uterus. (Note that implantation can more rarely happen as early as 6 days or as late as 12 days, so you and the PWH may choose to use the more conservative 6 days to calculate their safety zone.) The day of implantation is calculated by adding 8 to the day of ovulation (in this regular cycle scenario, that is Day 22).
  • Based on the assumptions above, medicines need to have been eliminated by the end of Day 21 for safe implantation on Day 22. To calculate the safety zone days, subtract the number of days needed to eliminate the medicines from Day 21.
Medicine Half-life Days to eliminate Safety zone days
Adderall up to 14 hours 3 1 to 18
Clarithromycin up to 9 hours 2 1 to 19
Methylphenidate about 3.5 hours less than 1 1 to 20
Modafinil/armodafinil about 15 hours 3 1 to 18
Pitolisant 7.5 to 24.2 hours up to 5 1 to 16
Ritalin LA 1.3 to 7.7 hours up to 2 1 to 19
Oxybates (including lower-sodium and extended-release) 0 to 1 hour less than 1 1 to 20
Solriamfetol about 7.1 hours 2 1 to 19
Example 

A PWH (with a regular 28-day cycle with ovulation on Day 14) taking modafinil may take it for 18 days starting on the first day of menstruation. By stopping it after Day 18, there is enough time (3 days) for modafinil to clear their system by the end of Day 21, before the most likely date of implantation on Day 22. If pregnancy occurs, the embryo should never have been exposed to modafinil. If pregnancy does not occur, menstruation will start and modafinil may be taken for another 18 days. In the case of early bleeding, PWH should wait until Day 1 of their next predicted menstrual cycle and then take a highly sensitive urine pregnancy test before deciding to restart their medicines.

Irregular Menstruation

If the menstrual cycle is irregular, then ovulation and therefore fertilization and implantation cannot be predicted reliably. Therefore, it is safest to assume a very short cycle of 21 days, in which ovulation occurs around Day 7 and implantation 8 days later at Day 15 (as opposed to Day 22 for the table above). In this case, medicines need to be eliminated by the end of Day 14.

What are some strategies for reducing medicine risks?

If you and a PWH decide to continue their hypersomnia medicines during pregnancy, here are a few strategies for reducing risk:

  • Encourage PWH to seek prenatal care as soon as possible, ideally before trying to get pregnant.
  • Consider avoiding medicines with possible risk while trying to conceive and during the first trimester (when organogenesis occurs).
  • Change dosing.
    • Stabilize the PWH on the lowest effective dose as soon as possible, although it may be unclear if risks are connected with dose.
    • For medicines that can negatively affect labor and newborn behavior, use the lowest effective dose or stop them late in pregnancy. 
  • Monitor fetal growth. 
    • Some medicines can negatively affect fetal growth, so use repeat (serial) ultrasounds to estimate fetal size, usually every 4 weeks. 
    • If you find suboptimal growth, reducing the dose or stopping the medicines may help.
  • Monitor fetal kick counts.
    • Advise pregnant people taking medicines to track fetal kick counts and be familiar with the pattern that’s normal for them.
    • Track whether kick counts change when taking hypersomnia medicines, and check that the kick counts stay within acceptable levels.
    • If kick count patterns change, especially if kick counts are lower than normal for that person, advise hospitalization for further evaluation. The low count may indicate poor fetal oxygenation or altered acid/base status.

Role for maternal-fetal medicine

Maternal-fetal medicine (MFM) is a subspecialty of obstetrics that is devoted to the monitoring and management of “high-risk” pregnancies. “High-risk” may be defined in a number of ways, but typically implies any maternal or fetal condition or complication requiring monitoring and care above and beyond the routine or the comfort level of a generalist OB/GYN. 

PWH can have uneventful (“low-risk”) pregnancies, and their OB/GYN may feel that a consultation with MFM is unnecessary, especially if:

  • The OB/GYN does ultrasounds and fetal monitoring 
  • The OB/GYN is experienced with hypersomnias
  • The PWH is otherwise healthy
  • The PWH isn’t taking any medicines 

Why refer to MFM?

An MFM specialist can provide: 

Risk evaluation and decision support

  • Counseling as soon as pregnancy is planned or diagnosed
    • Review of the potential risks of medicines on pregnancy and nursing
    • Review of the potential risks of a sleep disorder on pregnancy and nursing
  • Reassurance and guidance to the PWH and their other doctors

Testing

  • An early ultrasound to provide a reliable due date and exact gestational age at any given point in time
  • Ultrasounds to document the entire fetal anatomy and identify any anomalies (“birth defects”)
  • Predicting or diagnosing chromosomal or genetic abnormalities
  • Following fetal growth and observing fetal behavior as a means of assessing wellbeing, typically every 4 to 6 weeks
  • A variety of forms of fetal monitoring in the third trimester, especially for pregnancies with an increased risk for stillbirth

Fetal monitoring for pregnant PWH who continue with medicine

If a PWH is considering taking medicine during pregnancy or nursing, it may be helpful to consult MFM for a detailed discussion of the risks and benefits. If the PWH decides to continue medicines during pregnancy, consider using extra fetal monitoring because of the unclear association between hypersomnia medicines and birth defects, fetal growth, and stillbirth.

Monitor and treat pregnancy-induced changes that can lead to worsened sleepiness

Pregnancy may cause changes that lead to worsened sleepiness, such as:

  • Anemia (low iron, b12, or folate). 
  • Reflux, sleep apnea, and restless legs syndrome, which normally go away soon after pregnancy but may need treatment during pregnancy. (For more information, see Pien, 2004 and Silvestri et al, 2019.)

How much caffeine is safe during pregnancy?

Many PWH use caffeine to help their symptoms. Experts generally recommend limiting daily caffeine to 200 to 300 mg (about 2 to 3 6-ounce cups of coffee) during pregnancy and nursing due to possible risks to the baby. Weigh the risks and benefits as you do for prescription medicines.

How can hypersomnias affect delivery? 

Study results are mixed on the effect of hypersomnias during and after delivery of a baby.

Studies in the U.S. and Europe have compared births for people with narcolepsy to a control population.

  • The U.S. study (Black, 2017) reported no differences in: 
    • How the baby was delivered — spontaneous vaginal vs. induced vaginal, vs. Cesarean delivery 
    • Baby’s gestational age at delivery
    • Baby’s weight at delivery
  • The European survey study (Maurovich-Horvat, 2013) reported similar results, except in how babies were delivered — people with narcolepsy with cataplexy were more likely to have a C-section 

Cataplexy during delivery is rare, but it is more likely right after delivery due to the heightened emotions of childbirth. Take extra care when giving the baby to a person with narcolepsy with cataplexy for the first time.

Hospitalization and anesthesia may affect hypersomnia symptoms and appropriate treatment strategies — including both medicines and sleep schedules. See our web page “Clinician planning for anesthesia, hospitalization, and medical emergencies” to help your patient make a care plan well in advance of delivery or other hospitalization.

How can hypersomnias affect nursing and pumping?

Many parents are very motivated to give their baby human milk through nursing or pumping and are happy to provide whatever milk they can produce. Consider referring PWH to a lactation consultant for additional support, as there are many tools ​to help nursing and pumping.

Low milk supply

PWH may have a lower milk supply if their sleep schedule doesn’t allow for frequent nursing or pumping. The more a parent nurses or pumps, the more milk they will make. Any parent who is unable to nurse their baby or pump at least 8 times in 24 hours is more likely to have a low milk supply.

To help raise milk production, parents can:

  • Record how often they nurse or pump, with a goal of 8 to 12 or more times every 24 hours
  • Be certain their baby is actively nursing by watching their jaw movements
  • Fully empty their breasts of milk by pumping all milk that remains after nursing
  • Continue pumping for 5 to 10 minutes past the end of milk flow

Plugged milk ducts and breast infections

PWH who have a high milk supply will have a higher risk of plugged milk ducts if their sleep needs don’t allow them to remove their milk often enough. This can lead to breast infections. Advise them to completely empty their breasts every time they nurse or pump and record how often they nurse or pump, with a goal of 8 to 10 times every 24 hours. Nursing or pumping more often is likely to further raise their milk supply. 

Advise PWH to sleep flat on their back whenever possible and to make sure their bra fits their largest breast size well. Rolled towels can help them sleep on their back. Sleeping in other positions, where they may lay on their breasts, or wearing a bra that is too tight raises their risk of plugged milk ducts. This can lead to breast infections.

Medicines and human milk

Many medicines pass to human milk, whether the parent is nursing or pumping. For all medicines, it is important to weigh the potential risks against the known benefits of human milk and nursing, along with the benefits of the medicine for the parent’s symptoms. Each parent should make their own informed decision after discussion with their doctors. 

These medicines are believed to be safe based on very small studies:

  • When taken as directed, the relative infant dose is less than 10% and within a range that is generally accepted as being ‘safe’ in the short term. 
  • “A small study of four infants whose mothers were taking dextroamphetamine for ADHD found no problems in the health and growth of those infants up to 6-10 months of age. Babies that are born preterm and those under two months of age should be monitored for decreased appetite, sleeplessness, and irritability. … Some evidence suggests that large doses of dextroamphetamine could lower milk supply.” (Read more at MotherToBaby.org.)
  • In a study of 103 nursing infants, there were no reports of infant insomnia or stimulation (Pascoe, 2021).
  • In general for antidepressants, the benefits of human milk feeding appear to outweigh the small risk posed (UpToDate, 2021). 
  • For more details specific to fluoxetine (such as Prozac), visit LactMed.
  • For more details specific to venlafaxine (such as Effexor), visit LactMed.
  • Studies of doses to treat depression (75 to 150 mg) find acceptably-low infant dosages. 
  • The typical dose of 10 to 50 mg used to treat cataplexy is substantially lower and would pass even less medicine to the infant. 
  • Read more at Drugs.com.
  • When taken as prescribed, methylphenidate, which passes into human milk at low levels, is not expected to cause problems. It’s generally undetected in the infant’s blood.
  • Reports on 5 babies, whose nursing parents were taking 35 to 80 mg per day showed normal infant weight, sleeping and feeding habits.
  • Read more at MotherToBaby.org.
  • A single case of a nursing parent taking modafinil showed that the infant received a weight-adjusted dosage of 5.3% of the parental dosage, which is considered acceptably safe (Aurora, 2018).

“Changes in sleep patterns have been observed in breastfed infants from exposed mothers, which may be consistent with the effects of sodium oxybate on the nervous system.” (European Medicines Agency’s Xyrem Summary 2022). However, given sodium oxybate’s short half-life and limited time in human milk, you may advise the following precautions to avoid exposing the baby:

  • In the evening, nurse or pump just before taking the first dose.
  • During the night, feed the baby with formula (or milk pumped when not exposed to oxybates). Throw out any pumped milk. However, this pumping should help improve the overall milk supply.
  • Wait at least 5 hours after the last oxybate dose before nursing or saving pumped milk again. Even though oxybate was on board during milk production, after 5 hours the level of oxybate in the milk should be down to a safe level.

For a summary of studies of sodium oxybate and human milk feeding, visit LactMed. The half-lives for both sodium and lower-sodium oxybate are reported for their metabolite (GHB). Therefore, it’s likely that lower-sodium oxybate (Xywav) behaves similarly to sodium oxybate (Xyrem) in human milk, but researchers haven’t yet studied that.

Note for extended-release oxybates (such as Lumryz): 

The time to elimination of the once-nightly dose from the body is similar to that for 2 doses of immediate-release oxybate. Therefore, infant exposure can likely be lowered with similar precautions, although there aren’t specific nursing data. Wait at least 9 hours after the once-nightly oxybate dose before nursing or saving pumped milk.

  • A study of 8 lactating parents each given a single dose of pitolisant showed a mean weight-adjusted infant dosage of 0.56% of the parental dosage, which is considered acceptably safe. To read more, visit LactMed.
  • A study of 6 lactating parents each given a single dose of solriamfetol showed a mean weight-adjusted infant dosage of 5.5% of the parental dosage, which is considered acceptably safe. To read more, visit LactMed.

These medicines may have more risk:

  • The relative infant dose is less than 1%, which is considered acceptably safe. 
  • However, antibiotics that are present in human milk may cause non-dose-related changes in bowel flora. Therefore, infants should be monitored for thrush, diarrhea, or other GI disturbances. 
  • A study comparing the breastfed infants of nursing parents taking amoxicillin to those taking a macrolide antibiotic reported adverse reaction “in 12.7% of the infants exposed to macrolides which was similar to the rate in amoxicillin-exposed infants. Reactions included rash, diarrhea, loss of appetite, and somnolence” (Lactmed).
  • The lactation studies on clarithromycin are for short-term use as an antibiotic. The risks are likely to be higher for the chronic use required for treatment of hypersomnias.
  • “Unconfirmed epidemiologic evidence indicates that the risk of infantile hypertrophic pyloric stenosis might be increased by maternal use of macrolide antibiotics during the first two weeks of breastfeeding, but others have questioned this relationship” (Lactmed).

How can hypersomnias affect baby care?

A parent with a hypersomnia is usually even more exhausted than most parents. In a European study of 249 mothers with narcolepsy, 60% reported that care of their baby was negatively affected by their symptoms (Maurovich-Horvat et al, 2013). 

The symptoms disrupting care included:

PWH may need help to prevent accidents, such as falls or drowning while bathing, especially if they typically experience these symptoms.

The American Academy of Pediatrics Updated 2022 Recommendations for Reducing Infant Deaths in the Sleep Environment (Moon, 2022) generally advise against parents sharing a bed with an infant (1 year or younger), although it is safe to sleep in the same room. Bed-sharing could increase the risk of SIDS (sudden infant death syndrome), suffocation, or strangulation. Research has shown a high risk of infants being trapped or tangled in upholstered chairs, couches and on beds with extra pillows and bedding when adults fall asleep, especially if the infant is 6 months or younger.

People with impaired alertness, difficulty waking up, or using a sedating medicine have a risk of infant sleep-related death during bed-sharing that is more than 10 times higher than the usual risk with bed-sharing (Moon, 2022). Therefore, PWH are likely at very high risk if they:

  • Have uncontrolled hypersomnia symptoms, such as very deep sleep with difficulty waking or severe sleep inertia
  • Take sedating medicines like oxybates 

How can you help reduce the risks of accidents?

  • Help get symptoms as well-controlled as possible
  • Advise PWH to get as much sleep as they need, including sleeping when their baby sleeps
  • Advise PWH to prepare ahead of time to have as much help with their baby as you both think they may need. For example, they may need to have someone else at home to respond to their baby when they’re sleeping, especially if they:
    • Take an oxybate medicine, such as Xyrem
    • Have very deep sleep or sleep drunkenness
  • Discuss accident prevention guidelines for people with seizures, who have similar risks as PWH (see this WebMD article); for example:
    • Lower the chance of baby falling by changing the baby on the floor rather than a changing table
    • Lower the chance of baby falling by using a sling or similar baby carrier, as long as the PWH can be alert to their infant’s movements (read more at Carrying Matters)
    • Lower the chance of baby drowning by sponge bathing instead of tub bathing if the PWH is alone and symptoms aren’t well-controlled
  • Advise PWH how to lower the chance of infant sleep-related death, including SIDS, related to falling asleep while feeding their infant. They can:
    • Sit on the floor (perhaps on a very firm cushion or mattress) or lie on a firm mattress (without any bedding other than a tight-fitting bottom sheet)
    • Avoid couches and armchairs if they might fall asleep because sleeping on couches and armchairs increases the risk for infant death by up to 67 times 
    • Avoid slings or baby carriers if there is any chance they may fall asleep or not be alert to their infant’s movements.
    • Place their infant back on a separate sleep surface as soon as they finish feeding them or as soon as the PWH wakes up 
    • Have another awake and alert adult in the room 
    • Have a partner or another helper bottle feed baby

Acknowledgements

  • Based on the 2018 HF conference presentation by Isabelle Arnulf, MD, PhD, HF medical advisory board member
  • Maternal-fetal medicine review and approval by Christopher T. Lang, MD
  • OB/GYN review and approval by Elezabeth Young, MD
  • Sleep medicine review and approval by Lynn Marie Trotti, MD, MSc and Isabelle Arnulf, MD, PhD, members, HF medical advisory board
  • Pediatric review and approval by Kiran Maski, MD, MPH, HF medical advisory board member
  • Lactation consultant review and approval and additional contributions by Valerie Vanderlip, IBCLC 
  • Lactation consultant review and approval by Sarah Briggs Williams RN, BSN, IBCLC
  • Contributions by Jodi Godfrey, PhD

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Published Oct. 31, 2023 |
Revised Jan. 31, 2024
Approved by our medical advisory board