Safety of Medications Used to Treat Sleep Disorders in Pregnancy

If you have difficulty sleeping during pregnancy, you may want to learn about treatment options. Certain conditions such as insomnia and restless legs syndrome (RLS) may occur more frequently during pregnancy. Other sleep disorders such as narcolepsy and sleep behaviors known as parasomnias may persist through pregnancy and require treatment. It is important to understand how the safe use of medications during pregnancy is determined. Then, you can consider what options your healthcare provider might have to treat your condition and help you to sleep better. Discover what medications are safest to use to treat sleep disorders in pregnancy.

Pregnant woman with pill bottle
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Categorizing Drug Safety

The first choice to treat a sleep disorder in a pregnant woman is to use lifestyle changes to help relieve the condition and avoid all medications. For those suffering from insomnia, a treatment with cognitive behavioral therapy for insomnia (CBTi) may be effective. Even in RLS, a variety of changes can lead to relief without resorting to medication.

In severe conditions, some medication must be used with caution. The concern is that many medications have not been tested in large numbers of women. No one wants to cause a birth defect. Drugs that do so are called teratogenic (literal translation is "monster forming"). Therefore, many studies are not done in pregnant women because even a small risk is not deemed to be acceptable. Nevertheless, experience and studies in animals have given us some guidance on medication safety in pregnancy.

Categories of Medications for Use in Pregnancy

The following classification of the effects of medications during pregnancy is used:

  • Category B: Animal studies have not indicated a fetal risk but no controlled studies in pregnant women exist, or animal studies have shown an adverse fetal effect that is not confirmed in controlled studies in women in the first trimester. There is no evidence in later trimesters.
  • Category C: Animal studies have shown adverse fetal events, but no controlled studies in pregnant women exist, or studies in humans and animals are not available; thus, the medication is given if the potential benefit outweighs the risk.
  • Category D: Risk to fetus is present, but benefits may outweigh the risk if a life-threatening or serious disease exists.
  • Category X: Studies in animals or humans show fetal abnormalities; the drug is contraindicated for pregnant women.

Therefore, medications are deemed to be safer when additional research supporting safety in humans is available. However, an individual’s risk with the use of any drug may still result in unacceptable consequences.

Medication Use for Sleep Disorders

Using the categories outlined above, medications for the treatment of the most common sleep disorders during pregnancy can be grouped. These conditions include insomnia, RLS, narcolepsy, and parasomnias. The safety of drugs decreases as you move from Category B to Category C to Category D and, finally, to Category X.

According to published research, hypnotic benzodiazepine receptor agonists (zaleplon, zolpidem and eszopiclone) are the most commonly prescribed drugs for insomnia in pregnant women, but other medications are also sometimes prescribed.

Consider the sleeping medications available during pregnancy for each of the following conditions:

Insomnia

Category B

Category C

  • Sedatives and Hypnotics (Benzodiazepines): Zaleplon
  • Anticonvulsants: Gabapentin
  • Antidepressants and Depressants: Amitriptyline, Doxepin, Trazodone

Category D

  • Sedatives and Hypnotics (Benzodiazepines): Alcohol, Alprazolam, Diazepam, Lorazepam, Midazolam, Secobarbital​

Category X

  • Sedatives and Hypnotics (Benzodiazepines): Alcohol (if used in large amounts or for prolonged periods), Estazolam, Flurazepam, Quazepam, Temazepam, Triazolam

Restless Legs Syndrome or Willis-Ekbom Disease

Category B

Antiparkinsonian Agents (Dopaminergics): Bromocriptine, Cabergoline

Narcotic Agonist Analgesics (Opioids) (see D): Meperidine, Oxymorphone, Methadone, Oxycodone

Category C

  • Central Analgesics: Clonidine
  • Anticonvulsants: Gabapentin, Lamotrigine
  • Antiparkinsonian Agents (Dopaminergics): Carbidopa, Levodopa, Pramipexole, Ropinirole
  • Narcotic Agonist Analgesics (Opioids) (see D): Codeine, Morphine, Propoxyphene, Hydrocodone
  • Antidepressants and Depressants: Amitriptyline, Doxepin, Trazodone

Category D

  • Anticonvulsants: Clonazepam, Carbamazepine
  • Narcotic Agonist Analgesics (Opioids) (if used for prolonged periods or in high doses at term): Meperidine, Oxymorphone, Methadone, Oxycodone, Codeine, Morphine, Propoxyphene, Hydrocodone

Category X

  • Sedatives and Hypnotics (Benzodiazepines): Estazolam, Flurazepam, Quazepam, Temazepam, Triazolam

Narcolepsy

Category B

  • Stimulants: Caffeine, Permoline
  • Antidepressants and Depressants: Sodium oxybate (Xyrem)

Category C

  • Antidepressants and Depressants: Fluoxetine, Paroxetine, Protriptyline, Venlafaxine
  • Stimulants: Dextroamphetamine, Mazindol, Methamphetamine, Methylphenidate, Modafinil

Category D

  • None

Category X

  • None

Parasomnias (Sleep Behaviors)

Category B

  • None

Category C

  • Antidepressants and Depressants: Imipramine, Paroxetine, Sertraline, Trazodone

Category D

  • Sedatives and Hypnotics (Benzodiazepines): Diazepam
  • Anticonvulsants: Clonazepam, Carbamazepine

Category X

  • None

How to Choose a Medication

After considering the list of medications available for the treatment of sleep disorders during pregnancy, you should have a candid discussion of your situation with your healthcare provider. You will want to consider the severity of your symptoms. Do you even require treatment or will the condition pass on its own? If possible, you should first try non-pharmacological treatments including lifestyle changes. If you can address stress, alter your diet, or improve your condition with exercise, you may not need to consider a potentially risky medication.

If you do decide to choose to take a medication during pregnancy, discuss the potential risks with your healthcare provider and pharmacist to ensure you are fully informed of the potential consequences. You can be your best advocate, both for yourself and your unborn child.

4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Gupta R, Dhyani M, Kendzerska T, et al. Restless legs syndrome and pregnancy: prevalence, possible pathophysiological mechanisms and treatment. Acta Neurol Scand. 2016;133(5):320–329. doi:10.1111/ane.12520

  2. Haynes J, Talbert M, Fox S, Close E. Cognitive Behavioral Therapy in the Treatment of Insomnia. South Med J. 2018;111(2):75-80. doi: 10.14423/SMJ.0000000000000769

  3. Alwan S, Chambers CD. Identifying Human Teratogens: An UpdateJ Pediatr Genet. 2015;4(2):39–41. doi:10.1055/s-0035-1556745

  4. Reichner CA. Insomnia and sleep deficiency in pregnancy. Obstet Med. 2015;8(4):168–171. doi:10.1177/1753495X15600572

Additional Reading
  • Kryger, MH et al. "Principles and Practice of Sleep Medicine." ExpertConsult, 5th edition, 2011, p. 1581.
Brandon Peters, M.D.

By Brandon Peters, MD
Brandon Peters, MD, is a board-certified neurologist and sleep medicine specialist.