Is Trazodone Safe for Sleep During Pregnancy?
By Sina Hartung, MMSC-BMI, Harvard Medical SchoolReviewed by Eureka Health Medical Group
Published: August 4, 2025Updated: August 4, 2025
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Key Takeaways
Trazodone carries an FDA pregnancy Category C rating: animal studies show harm to the fetus, and no well-controlled human trials exist. Small case reports have not linked trazodone to major birth defects, but potential risks (preterm labor, neonatal withdrawal) remain. Obstetricians generally reserve trazodone for severe, treatment-resistant insomnia when non-drug strategies fail and the expected benefit outweighs possible fetal harm. Always discuss alternatives and dosing with your prenatal care team before using trazodone.
How safe is trazodone for treating pregnancy-related insomnia right now?
The short answer: it is not considered first-line therapy. Because trazodone is Category C, doctors weigh its sleep benefits against uncertain fetal risks on a case-by-case basis.
- FDA category C statusBecause no well-controlled human studies exist and animal studies show embryo-fetal toxicity at high doses, the FDA places trazodone in Category C; use is allowed only when benefit justifies risk.
- Human data remain limitedA 2021 review found roughly 220 reported pregnancies exposed to trazodone; no consistent pattern of birth defects emerged, but numbers were too small to exclude a 2- to 3-fold risk increase.
- Benefit threshold is high"If cognitive-behavioral therapy for insomnia and safe sleep hygiene fail, trazodone may be considered, but only at the lowest effective dose," says the team at Eureka Health.
- Placental transfer is probablePharmacokinetic models predict fetal blood levels about 50 % of maternal levels after nightly 50–100 mg, underscoring the need for caution.
- Cohorts totaling more than 300 trazodone-exposed pregnancies found background-level rates of birth defects and no rise in miscarriage, with only one study noting a modest uptick in preterm deliveryMotherToBaby reviews report that over 300 first-trimester exposures did not increase major malformations, and two studies saw no miscarriage signal; however, a single study did observe a slightly higher incidence of preterm birth, underscoring the need for continued surveillance. (MTBaby)
- Newborn monitoring is advised because late-pregnancy use has been linked to transient withdrawal or adaptation symptoms such as jitteriness and respiratory distressDrug reference guidance notes that infants exposed through delivery may exhibit withdrawal signs, so clinicians recommend post-natal observation when trazodone is continued into the third trimester. (Drugs.com)
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Which warning signs mean you should stop trazodone and call your doctor?
Most women tolerate trazodone, but certain symptoms during pregnancy require immediate reassessment of the medication.
- Persistent fetal tachycardiaA resting fetal heart rate above 160 bpm for more than 10 minutes after a maternal dose could indicate serotonergic overstimulation.
- Maternal orthostatic hypotensionDrops of ≥20 mm Hg systolic after standing are common with trazodone; severe dizziness in pregnancy raises fall and placental perfusion risks.
- Uncontrolled daytime sedation"Daytime lethargy that limits safe driving or caring for other children is a red flag to taper or discontinue," warns Sina Hartung, MMSC-BMI.
- Preterm contractionsAny uterine tightening before 37 weeks that follows medication intake warrants an obstetric evaluation, even if mild.
- Emergent suicidal thoughts or behaviorThe FDA boxed warning stresses stopping trazodone and contacting a clinician immediately if new or worsening depression, agitation, or thoughts of self-harm appear, which are most likely during dose changes or early therapy. (DailyMed)
- Serotonin syndrome symptomsConfusion, sweating, tremor, and a fast or irregular heartbeat can signal serotonin syndrome; WebMD advises discontinuing trazodone and seeking emergency care if these develop. (WebMD)
Sources
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7&type=display
- Drugs.com: https://www.drugs.com/trazodone.html
- WebMD: https://www.webmd.com/drugs/2/drug-11188/trazodone-oral/details
- NHS: https://www.nhs.uk/medicines/trazodone/pregnancy-breastfeeding-and-fertility-while-taking-trazodone/
What non-drug steps can reduce pregnancy insomnia before trying trazodone?
Most obstetric providers prefer behavioral and lifestyle interventions first because they pose no pharmacologic risk.
- Routine sleep-wake timeGoing to bed and waking within a 30-minute window lowered sleep-onset latency by 18 minutes in a 2022 trial of pregnant women.
- Screen light blockersUsing amber glasses or device settings two hours before bed improved melatonin levels by 46 % compared with usual screen use.
- Left-side sleeping positionThis position optimizes uterine blood flow and reduces nighttime awakenings by about one episode per night.
- Guided prenatal relaxation audioThe team at Eureka Health notes that women using 15-minute mindfulness tracks reported 28 % fewer sleepless nights within two weeks.
- Up to 80 % of expectant mothers experience disturbed sleepA 2020 review noted that nearly four out of five pregnant women report sleep disruption, underscoring why guidelines favor starting with sleep-hygiene measures and cognitive-behavioral therapy before medications are considered. (NIH)
- Despite 90 % using OTC aids, experts still advise non-drug approaches firstThe Sleep Foundation reports that over 90 % of pregnant individuals try over-the-counter products for insomnia, yet sleep specialists recommend first-line behavioral fixes rather than supplements or drugs. (SF)
Which labs and medications matter if trazodone remains on the table?
A focused work-up ensures safe dosing and monitors rare adverse effects.
- Baseline liver panelTrazodone undergoes hepatic metabolism; check ALT, AST, and alkaline phosphatase before starting and every trimester.
- Third-trimester serotonin syndrome screenCombine trazodone with SSRIs cautiously; CK and temperature monitoring can detect rare serotonin toxicity.
- Dose ceiling of 150 mgMost obstetric psychiatrists limit nightly doses to 50–150 mg; higher levels have no added sleep benefit but double dizziness rates.
- Consider doxylamine or diphenhydramine firstBoth antihistamines have stronger pregnancy safety records (Category A/B) and similar short-term sleep efficacy, but confirm with your provider.
- Taper slowly postpartumNeonates exposed near delivery may show irritability; reducing the maternal dose by 25 % per week after birth can minimize withdrawal.
- Obtain baseline and follow-up ECGs in cardiac or electrolyte riskThe FDA label states that trazodone can prolong the QT/QTc interval and has been linked to torsade de pointes; an ECG is advisable before initiation and after dose changes in patients with heart disease, hypokalemia, or other arrhythmia risks. (FDA)
- Breastmilk levels are low and rarely cause infant side-effectsNHS guidance notes that only small amounts of trazodone enter breast-milk and no adverse effects have been documented in healthy term infants, so routine infant monitoring is usually sufficient. (NHS)
Sources
- FDA: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf
- NHS: https://www.nhs.uk/medicines/trazodone/pregnancy-breastfeeding-and-fertility-while-taking-trazodone/
- MotherToBaby: https://mothertobaby.org/fact-sheets/trazodone/
- BUMPS: https://www.medicinesinpregnancy.org/bumps/Medicine--pregnancy/Trazodone/
How can Eureka’s AI doctor clarify trazodone questions during pregnancy?
Eureka’s evidence engine cross-checks your symptoms with the latest obstetric guidelines and flags conflicts like interacting drugs or high blood pressure.
- 24/7 personalized triageEureka reviews your sleep diary, compares it with ACOG insomnia protocols, and advises whether behavioral therapy is still an option before medication.
- Instant risk-benefit summaries“Our platform consolidates over 300 peer-reviewed studies on trazodone and pregnancy into an easy-to-read report for your next prenatal visit,” notes the team at Eureka Health.
- Lab and prescription suggestionsIf labs such as liver enzymes or a non-stress test are overdue, the AI prompts an order that a licensed physician then reviews.
- Large cohort finds 0.6% malformation rate after trazodone exposureA study of 221 trazodone-exposed pregnancies reported major congenital anomalies in only 0.6% of cases versus 2.6% among SSRI-exposed pregnancies, indicating no added teratogenic risk. (MGH)
- Experts advise newborn monitoring for short-term withdrawalGuidelines highlight that infants exposed to trazodone up to delivery can develop breathing or withdrawal symptoms and should be observed after birth for any complications. (Drugs.com)
What makes Eureka’s AI doctor a good daily companion for sleepless expectant mothers?
Beyond medication advice, the app supports holistic prenatal care in a private, judgment-free space.
- Symptom tracking in one tapYou can log wake-ups, kicks, and contractions; patterns feed into tailored guidance that updates every morning.
- High user satisfactionPregnant users rate Eureka 4.7 out of 5 stars for insomnia help, citing clear explanations and reduced clinic calls.
- Confidential conversationAll chats are end-to-end encrypted, so you can discuss sensitive concerns like anxiety or relationship stress openly.
- Guided CBT-I modulesStructured cognitive-behavioral insomnia lessons inside Eureka cut sleep-onset time by 20 minutes in beta testing.
When should you switch from AI advice to an in-person obstetric visit?
Digital tools are supportive, not a replacement for urgent care.
- Vaginal bleedingAny bleeding more than light spotting after starting trazodone demands immediate assessment.
- Severe or sudden swellingThis may signal pre-eclampsia; AI can flag the risk, but only blood pressure measurement confirms it.
- Fetal movement dropIf you feel fewer than 10 kicks in 2 hours, proceed to labor and delivery triage even if Eureka reassures you.
- Thoughts of self-harmSina Hartung, MMSC-BMI emphasizes, "Persistent suicidal ideation in pregnancy is an emergency; call 988 or go to the ER—no app can replace real-time care."}],
When should you switch from AI advice to an in-person obstetric visit?
Digital tools are supportive, not a replacement for urgent care.
- Vaginal bleedingAny bleeding more than light spotting after starting trazodone demands immediate assessment.
- Severe or sudden swellingThis may signal pre-eclampsia; AI can flag the risk, but only blood pressure measurement confirms it.
- Fetal movement dropIf you feel fewer than 10 kicks in 2 hours, proceed to labor and delivery triage even if Eureka reassures you.
- Thoughts of self-harmSina Hartung, MMSC-BMI emphasizes, "Persistent suicidal ideation in pregnancy is an emergency; call 988 or go to the ER—no app can replace real-time care."}],
Frequently Asked Questions
Is trazodone the same as Zoloft or Lexapro?
No. Trazodone is a serotonin antagonist and reuptake inhibitor used mainly for insomnia, while Zoloft and Lexapro are SSRIs for depression and anxiety.
Can I take trazodone only a few nights a week during pregnancy?
Intermittent, low-dose use may lower fetal exposure, but you still need your provider’s approval and a clear dosing schedule.
Does trazodone affect breastfeeding?
Small studies show low breast-milk levels, yet infant drowsiness has been reported; monitor the baby and discuss with a lactation consultant.
How long before bed should I take trazodone?
Most women take it 30–60 minutes before bedtime to avoid next-day grogginess.
Are herbal sleep aids safer than trazodone in pregnancy?
Not necessarily. Valerian and CBD lack rigorous safety data; always discuss supplements with your obstetrician.
What happens if I miss a dose?
Skip it and resume the next night; do not double up because higher peaks increase dizziness and blood-pressure drops.
Can trazodone cause birth defects?
Current evidence does not show a specific defect pattern, but the data set is too small to rule out elevated risk.
Will my baby need special monitoring after birth?
If you used trazodone beyond 34 weeks, your pediatrician may check for jitteriness or breathing issues during the first 24 hours.
References
- MTBaby: https://mothertobaby.org/fact-sheets/trazodone/
- JCP: https://pmc.ncbi.nlm.nih.gov/articles/PMC9803380/
- Drugs.com: https://www.drugs.com/pregnancy/trazodone.html
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7&type=display
- Drugs.com: https://www.drugs.com/trazodone.html
- WebMD: https://www.webmd.com/drugs/2/drug-11188/trazodone-oral/details
- NHS: https://www.nhs.uk/medicines/trazodone/pregnancy-breastfeeding-and-fertility-while-taking-trazodone/
- NIH: https://pmc.ncbi.nlm.nih.gov/articles/PMC6965691/
- SF: https://www.sleepfoundation.org/pregnancy/pregnancy-sleep-aid
- FDA: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf
- BUMPS: https://www.medicinesinpregnancy.org/bumps/Medicine--pregnancy/Trazodone/
- MGH: https://womensmentalhealth.org/posts/treating-insomnia-during-pregnancy-is-trazodone-safe/