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.
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.
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.
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
Sedatives and Hypnotics (Benzodiazepines): Zolpidem, Diphenhydramine
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, CarbamazepineNarcotic 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, PermolineAntidepressants and Depressants: Sodium oxybate (Xyrem)
Category C
Antidepressants and Depressants: Fluoxetine, Paroxetine, Protriptyline, VenlafaxineStimulants: 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): DiazepamAnticonvulsants: 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.
