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Remimazolam: Drug information

Remimazolam: Drug information
(For additional information see "Remimazolam: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Personnel and equipment for monitoring and resuscitation

Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer remimazolam. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Remimazolam has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period. Resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of remimazolam.

Risks from concomitant use with opioid analgesics and other sedative-hypnotics

Concomitant use of benzodiazepines, including remimazolam, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous remimazolam can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.

Brand Names: US
  • Byfavo
Pharmacologic Category
  • Benzodiazepine
Dosing: Adult
Sedation

Sedation:

Note: Individualize dosing and titrate to desired clinical effect; subsequent doses should be titrated on the basis of clinical judgement and assessment of the depth of sedation; if maintenance of procedural sedation is inadequate, consider alternative medications.

Induction of procedural sedation:

Healthy adults: IV: 5 mg over 1 minute.

American Society of Anesthesiologists physical status III or IV patients: IV: 2.5 to 5 mg over 1 minute based on general condition of patient.

Maintenance of procedural sedation:

Healthy adults: IV: 2.5 mg over 15 seconds as needed; at least 2 minutes must elapse prior to administration of any supplemental dose.

American Society of Anesthesiologists physical status III or IV patients: IV: 1.25 to 2.5 mg over 15 seconds as needed; at least 2 minutes must elapse prior to administration of any supplemental dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, pharmacokinetics were not altered in patients with mild to severe renal impairment.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: There are no specific dosage adjustments provided in the manufacturer’s labeling; use caution and carefully titrate to effect; lower frequency of supplemental doses may be needed.

Dosing: Older Adult

Refer to adult dosing; use caution and administer supplemental doses slowly.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Bradycardia (4% to 11%), decreased diastolic blood pressure (8% to 14%), hypertension (20% to 28%), hypotension (33% to 39%; increased diastolic blood pressure 10% to 25%), systolic hypertension (5% to 22%)

Respiratory: Hypoxia (22%), tachypnea (14%)

1% to 10%:

Cardiovascular: Tachycardia (8%)

Gastrointestinal: Nausea (4%)

Nervous system: Headache (3%)

Miscellaneous: Fever (4%)

Contraindications

Severe hypersensitivity to dextran 40 or products containing dextran 40.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis, may occur due to the presence of dextran.

Disease-related concerns:

• Hepatic impairment: Use caution in patients with severe hepatic impairment; carefully titrate to effect; lower frequency of supplemental doses may be needed.

• Respiratory disease: Reduce dose or avoid use in patients with respiratory disease, including chronic obstructive pulmonary disease or sleep apnea. Benzodiazepines may cause significant respiratory depression.

Concurrent drug therapy issues:

• Concomitant use with opioids: [US Boxed Warning]: Concomitant use of benzodiazepines, including remimazolam, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death; sedative effect may be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. These respiratory effects are more likely to occur in patients with obstructive sleep apnea, the elderly, and the American Society of Anesthesiologists physical status III or IV patients. Continuously monitor patients for respiratory depression and depth of sedation.

Special populations:

• Elderly patients: Potential for faster onset of loss of consciousness and longer duration of action. Sedating drugs may cause confusion and over sedation in the elderly; use with caution.

• Pediatric: Neurotoxicity may occur in pediatric patients (unapproved use), particularly after repeated or prolonged exposures to anesthetic agents early in life, which may result in adverse cognitive or behavioral effects; weigh benefits against risks of anesthesia prior to elective procedures.

Other warnings/precautions:

• Personnel and equipment for monitoring and resuscitation: [US Boxed Warning]: Only personnel trained in the administration of procedural sedation should administer remimazolam and must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Remimazolam has been associated with hypoxia, bradycardia, and hypotension; continuously monitor vital signs during sedation and during the recovery period. Resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Byfavo: 20 mg (1 ea) [contains dextran 40, lactose monohydrate]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Byfavo Intravenous)

20 mg (per each): $49.61

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Controlled Substance

C-IV

Administration: Adult

IV: Administer IV induction dose over 1 minute and maintenance dose over 15 seconds. Only persons trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer remimazolam.

Use: Labeled Indications

Sedation: Induction and maintenance of procedural sedation in adults undergoing procedures lasting ≤30 minutes.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

CloZAPine: Benzodiazepines may enhance the adverse/toxic effect of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. Monitor for respiratory depression, hypotension, and other toxicities if these agents are combined. Risk D: Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modification

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: CNS Depressants may enhance the CNS depressant effect of Doxylamine. Risk C: Monitor therapy

DroPERidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modification

Ilaprazole: May increase the serum concentration of Benzodiazepines. Risk C: Monitor therapy

Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Melatonin: May enhance the sedative effect of Benzodiazepines. Risk C: Monitor therapy

Methadone: Benzodiazepines may enhance the CNS depressant effect of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. Risk D: Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OLANZapine: Benzodiazepines may enhance the adverse/toxic effect of OLANZapine. Management: Monitor closely for hypotension, respiratory or central nervous system depression, and bradycardia if olanzapine is combined with benzodiazepines. Use of parenteral benzodiazepines with IM olanzapine is not recommended. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Oxybate Salt Products: Benzodiazepines may enhance the CNS depressant effect of Oxybate Salt Products. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Teduglutide: May increase the serum concentration of Benzodiazepines. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Theophylline Derivatives: May diminish the therapeutic effect of Benzodiazepines. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Zuranolone: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider therapy modification

Pregnancy Considerations

Benzodiazepines cross the placenta.

In utero exposure to benzodiazepines has the potential to cause harm to the fetus. Teratogenic effects have been observed in some studies; however, a clear association has not been reported and additional data are needed (Bellantuono 2013; Freeman 2018; Grigoriadis 2019; Noh 2022; Szpunar 2022; Tinker 2019; Wikner 2007). Exposure to a benzodiazepine late in pregnancy may cause neonatal sedation (hypotonia, lethargy, respiratory depression) and/or symptoms of neonatal withdrawal (feeding difficulties, hyperreflexia, inconsolable crying, irritability, restlessness, tremors). Data related to long-term effects on neurodevelopment are inconclusive (Chen 2022; Radojčić 2017; Sundbakk 2022; Wang 2022). Newborns exposed to remimazolam in utero should be monitored for feeding problems, respiratory depression, sedation, and withdrawal.

Based on animal data, repeated or prolonged use of general anesthetic and sedation medications that block N-methyl-D-aspartate receptors and/or potentiate GABA activity may affect brain development.

The American College of Obstetricians and Gynecologists recommends that pregnant patients should not be denied medically necessary surgery regardless of trimester. If the procedure is elective, it should be delayed until after delivery (ACOG 2019).

Breastfeeding Considerations

It is not known if remimazolam is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Lactating patients may express and discard milk for 5 hours after administration to decrease potential exposure to an infant via breast milk. Monitor breastfed infants for sedation, respiratory depression, and feeding problems.

The Academy of Breastfeeding Medicine recommends postponing elective surgery until milk supply and breastfeeding are established. Milk should be expressed ahead of surgery when possible. In general, when the child is healthy and full term, breastfeeding may resume, or milk may be expressed once the mother is awake and in recovery. For children who are at risk for apnea, hypotension, or hypotonia, milk may be saved for later use when the child is at lower risk (ABM [Reece-Stremtan 2017]).

Monitoring Parameters

Monitor vital signs continuously (during sedation and through the recovery period), especially for signs of respiratory depression, hypotension, hypoventilation, airway obstruction, apnea, and oxygen desaturation; cardiorespiratory complications (especially in elderly and hepatic impairment patients).

Mechanism of Action

Short-acting benzodiazepine (Griffin 2013). Binds to brain benzodiazepine sites (GABA-A receptors) while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor. Remimazolam does not show a clear selectivity between subtypes of the GABA-A receptor

Pharmacokinetics (Adult Data Unless Noted)

Duration:

Classified as a short-acting benzodiazepine; classification based on benzodiazepines with half-life of 1 to 12 hours (Griffin 2013).

Indication-specific durations:

Sedation: Time to full alertness: 11 to 14 minutes after last dose.

Distribution: Vd: 0.76 to 0.98 L/kg.

Protein binding: >91%; primarily to albumin.

Metabolism: Via conversion to primary inactive metabolite CNS7054 by tissue carboxylesterases (primarily type 1A), which is then subject to hydroxylation and glucuronidation.

Half-life elimination: 37 to 53 minutes.

Time to peak: Sedation: 3 to 3.5 minutes (single dose); 11 to 14 minutes (multiple dose).

Excretion: Urine (0.003% [unchanged]; 50% to 60% [inactive metabolite]).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Renal impairment: In patients with renal impairment, AUC and Cmax was not significantly different from normal to severe renal impairment.

Hepatic impairment: In patients with moderate to severe impairment, Cmax was reduced by 10% and 20%, half-life is prolonged by 60 and 105 minutes, and volume of distribution increased by 33% and 41%, respectively, compared to healthy patients.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CN) China: Rui ma;
  • (EE) Estonia: Byfavo;
  • (FI) Finland: Byfavo;
  • (GB) United Kingdom: Byfavo;
  • (HU) Hungary: Byfavo;
  • (NL) Netherlands: Byfavo;
  • (PR) Puerto Rico: Byfavo
  1. American College of Obstetricians and Gynecologists (ACOG). ACOG Committee Opinion No. 775: Nonobstetric surgery during pregnancy. Obstet Gynecol. 2019;133(4):e285-e286. doi:10.1097/AOG.0000000000003174 [PubMed 30913200]
  2. Bach V, Carl P, Ravlo O, et al. A randomized comparison between midazolam and thiopental for elective cesarean section anesthesia: III. Placental transfer and elimination in neonates. Anesth Analg. 1989;68(3):238-242. [PubMed 2919760]
  3. Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry. 2013;35(1):3-8. doi:10.1016/j.genhosppsych.2012.09.003 [PubMed 23044244]
  4. Byfavo (remimazolam) [prescribing information]. Indianapolis, IN: Acacia Pharma Inc; January 2023.
  5. Chen VC, Wu SI, Lin CF, Lu ML, Chen YL, Stewart R. Association of prenatal exposure to benzodiazepines with development of autism spectrum and attention-deficit/hyperactivity disorders. JAMA Netw Open. 2022;5(11):e2243282. doi:10.1001/jamanetworkopen.2022.43282 [PubMed 36413366]
  6. Freeman MP, Góez-Mogollón L, McInerney KA, et al. Obstetrical and neonatal outcomes after benzodiazepine exposure during pregnancy: results from a prospective registry of women with psychiatric disorders. Gen Hosp Psychiatry. 2018;53:73-79. doi:10.1016/j.genhosppsych.2018.05.010 [PubMed 29958100]
  7. Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013;13(2):214-223. [PubMed 23789008]
  8. Grigoriadis S, Graves L, Peer M, et al. Benzodiazepine use during pregnancy alone or in combination with an antidepressant and congenital malformations: systematic review and meta-analysis. J Clin Psychiatry. 2019;80(4):18r12412. doi:10.4088/JCP.18r12412 [PubMed 31294935]
  9. Noh Y, Lee H, Choi A, et al. First-trimester exposure to benzodiazepines and risk of congenital malformations in offspring: a population-based cohort study in South Korea. PLoS Med. 2022;19(3):e1003945. doi:10.1371/journal.pmed.1003945 [PubMed 35235572]
  10. Radojčić MR, El Marroun H, Miljković B, et al. Prenatal exposure to anxiolytic and hypnotic medication in relation to behavioral problems in childhood: a population-based cohort study. Neurotoxicol Teratol. 2017;61:58-65. doi:10.1016/j.ntt.2017.02.005 [PubMed 28259732]
  11. Reece-Stremtan S, Campos M, Kokajko L; Academy of Breastfeeding Medicine. ABM Clinical Protocol #15: analgesia and anesthesia for the breastfeeding mother, revised 2017. Breastfeed Med. 2017;12(9):500-506. doi:10.1089/bfm.2017.29054.srt [PubMed 29624435]
  12. Sundbakk LM, Gran JM, Wood ME, Handal M, Skurtveit S, Nordeng H. Association of prenatal exposure to benzodiazepines and Z-hypnotics with risk of attention-deficit/hyperactivity disorder in childhood. JAMA Netw Open. 2022;5(12):e2246889. doi:10.1001/jamanetworkopen.2022.46889 [PubMed 36520439]
  13. Szpunar MJ, Freeman MP, Kobylski LA, et al. Risk of major malformations in infants after first-trimester exposure to benzodiazepines: results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. Depress Anxiety. 2022;39(12):751-759. doi:10.1002/da.23280 [PubMed 35909254]
  14. Tinker SC, Reefhuis J, Bitsko RH, et al; National Birth Defects Prevention Study. Use of benzodiazepine medications during pregnancy and potential risk for birth defects, National Birth Defects Prevention Study, 1997-2011. Birth Defects Res. 2019;111(10):613-620. doi:10.1002/bdr2.1497 [PubMed 30891943]
  15. Wang X, Zhang T, Ekheden I, et al. Prenatal exposure to benzodiazepines and Z-drugs in humans and risk of adverse neurodevelopmental outcomes in offspring: a systematic review. Neurosci Biobehav Rev. 2022;137:104647. doi:10.1016/j.neubiorev.2022.104647 [PubMed 35367514]
  16. Wikner BN, Stiller CO, Bergman U, Asker C, Källén B. Use of benzodiazepines and benzodiazepine receptor agonists during pregnancy: neonatal outcome and congenital malformations. Pharmacoepidemiol Drug Saf. 2007;16(11):1203-1210. doi:10.1002/pds.1457 [PubMed 17894421]
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