Bonjesta, Diclegis

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Molly Becze, PharmD, BCPS
Updated on October 27, 2023

Doxylamine/pyridoxine (dox IL a meen & peer i DOX een) is a generic medication prescribed for nausea and vomiting during pregnancy. Doxylamine belongs to a group of drugs called antihistamines. Pyridoxine is another name for vitamin B6.

The Food and Drug Administration (FDA) has approved doxylamine/pyridoxine to treat nausea and vomiting during pregnancy (also known as “morning sickness“). It’s prescribed when other approaches haven’t worked for managing these symptoms.

Uses of doxylamine/pyridoxine

The Food and Drug Administration (FDA) approves prescription drugs such as doxylamine/pyridoxine for certain conditions. Approved uses for doxylamine/pyridoxine are described below.

Use for nausea and vomiting during pregnancy

Doctors may prescribe doxylamine/pyridoxine delayed-release* oral tablets for treating nausea and vomiting during pregnancy (also known as “morning sickness“). It’s used for this purpose in pregnant adults. It’s usually prescribed as a short-term treatment.

Nausea and vomiting are common symptoms during pregnancy. They most commonly occur early in pregnancy but can continue throughout the entire pregnancy.

Doxylamine/pyridoxine is prescribed when other approaches haven’t worked for managing these symptoms. For example, doctors typically recommend avoiding foods or smells that make you feel sick. They may also recommend eating small, frequent snacks instead of large meals.

Doctors may not prescribe doxylamine/pyridoxine for hyperemesis gravidarum (extremely severe nausea and vomiting during pregnancy). Pregnant people experiencing this condition usually need to receive care in a hospital.

* “Delayed release” means the drug is released into your body slowly over time.

Side effects of doxylamine/pyridoxine

Doxylamine/pyridoxine may cause mild or serious side effects. More common mild side effects of doxylamine/pyridoxine and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about doxylamine/pyridoxine’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for doxylamine/pyridoxine listed in the “Resources” section.

Mild side effects

More common mild side effects reported with doxylamine/pyridoxine are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about doxylamine/pyridoxine’s side effects, refer to the prescribing information for doxylamine/pyridoxine listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Doxylamine/pyridoxine delayed-release oral tablet’s mild side effects include:

• drowsiness, which can make it unsafe to drive or operate machinery
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for doxylamine/pyridoxine” section.

Serious side effects

Serious side effects of doxylamine/pyridoxine are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about doxylamine/pyridoxine’s side effects, refer to the prescribing information for doxylamine/pyridoxine listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, doxylamine/pyridoxine’s serious side effects include:

• severe drowsiness, which can lead to falls or other accidents*
• severe allergic reaction†

* Drinking alcohol or taking certain other medications that slow brain activity with doxylamine/pyridoxine is not recommended because it can increase these risks.
† For details about this side effect, see the “Interactions and warnings for doxylamine/pyridoxine” section.

Common questions about doxylamine/pyridoxine

Below you’ll find answers to a few commonly asked questions about doxylamine/pyridoxine.

Can doxylamine/pyridoxine be used for sleep?

Not usually. The combination of doxylamine/pyridoxine is prescribed for nausea and vomiting during pregnancy in adults. It contains 10 milligrams (mg) of each active ingredient.

One of the ingredients, doxylamine, is available as an over-the-counter sleep aid called Unisom SleepTabs. Each tablet contains 25 mg of doxylamine. It’s used to reduce difficulty in falling asleep in children ages 12 years and older and adults.

Talk with your doctor or pharmacist if you’re interested in learning about sleep aids that are safe during pregnancy.

What brand names are available for doxylamine/pyridoxine?

Doxylamine/pyridoxine is a generic drug. The brand-name version is Diclegis. A similar brand called Bonjesta is also available. However, the strengths of these products are different.

A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less than brand-name drugs.

If you’d like to know more about this, talk with your doctor or pharmacist.

How does doxylamine/pyridoxine work? And how long does it take to start working?

It isn’t clear how doxylamine/pyridoxine works for treating nausea and vomiting of pregnancy.

Doxylamine/pyridoxine starts working soon after your first dose. If you still have symptoms of nausea and vomiting the day after you start this medication, your doctor will likely increase your dose. Your doctor may increase your dosage up to as many as four tablets taken throughout the day (one tablet in the morning, one tablet in the afternoon, and two tablets at bedtime).

Talk with your doctor if you have questions about doxylamine/pyridoxine treatment or other ways to ease the nausea and vomiting of pregnancy.

Interactions and warnings for doxylamine/pyridoxine

Below, you’ll find information about doxylamine/pyridoxine’s possible interactions and warnings.

Interactions of doxylamine/pyridoxine

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take doxylamine/pyridoxine, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for doxylamine/pyridoxine” section below.

Warnings for doxylamine/pyridoxine

Some people should not take doxylamine/pyridoxine, and others should take it cautiously.

Doxylamine/pyridoxine could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether doxylamine/pyridoxine is a safe option for you.

Ask your doctor about specific warnings for doxylamine/pyridoxine, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Doxylamine/pyridoxine can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to doxylamine/pyridoxine or any of its ingredients, your doctor will likely not prescribe doxylamine/pyridoxine. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause difficulty breathing

If you have an allergic reaction to doxylamine/pyridoxine, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of doxylamine/pyridoxine

You should not take more doxylamine/pyridoxine than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much doxylamine/pyridoxine, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and doxylamine/pyridoxine

Information about doxylamine/pyridoxine and pregnancy and breastfeeding is described below.

Doxylamine/pyridoxine and pregnancy

Doxylamine/pyridoxine is considered safe to take during pregnancy.

Doxylamine/pyridoxine and breastfeeding

Doxylamine/pyridoxine should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with doxylamine/pyridoxine.

What to ask your doctor

Let your doctor know if you have questions about doxylamine/pyridoxine or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• What should I do if doxylamine/pyridoxine isn’t working for me?
• What are my options if I can’t afford doxylamine/pyridoxine?
• Are there any diet changes that may make doxylamine/pyridoxine more effective for me?

Resources

• Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/76d10d65-0279-4e86-8104-cade4343f839/spl-doc
• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Unisom SleepTabs, doxylamine succinate tablet. (2023). https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f591d52f-5610-4517-a96f-1ed63deb00bc&type=display

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.