Diclegis

Insomnia, Catarrh, Nausea and Vomiting + 3 more

Treatment

5 FDA approvals

10 Active Studies for Diclegis

What is Diclegis

Doxylamine

The Generic name of this drug

Treatment Summary

Doxylamine is a drug used to treat allergies and coughs. It has a sedative effect and can also be used to treat nausea and insomnia. Doxylamine has previously been used to treat Parkinson's disease, and is still used in veterinary medicine.

Unisom SleepTabs

is the brand name

image of different drug pills on a surface

Diclegis Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Unisom SleepTabs

Doxylamine

1978

82

Approved as Treatment by the FDA

Doxylamine, also known as Unisom SleepTabs, is approved by the FDA for 5 uses like Vomiting and Gastrointestinal distress .

Vomiting

Used to treat Vomiting in combination with Pyridoxine

Gastrointestinal distress

Used to treat Nausea in combination with Pyridoxine

Symptoms Flu

Used in combination with Doxylamine for Symptoms Flu

Catarrh

Used in combination with Doxylamine for Common Cold

Nausea and Vomiting

Used to treat Vomiting in combination with Pyridoxine

Effectiveness

How Diclegis Affects Patients

Doxylamine is an antihistamine used to treat allergies, hives, and hay fever. It is also used as a sleep aid and is much more powerful than other over-the-counter sleep aids. This drug is even more powerful than many prescription sedatives. It also has strong anticholinergic properties.

How Diclegis works in the body

Doxylamine is an antihistamine that blocks histamine from binding to cells, reducing allergic reactions and providing a sedative effect. It also has anticholinergic effects, which can help to reduce symptoms of allergies.

When to interrupt dosage

The recommended dosage of Diclegis is dependent upon the specified ailment, including Symptoms Flu, Nausea and Nausea and Vomiting. The amount of dosage fluctuates depending on the administration approach outlined in the table below.

Condition

Dosage

Administration

Nausea and Vomiting

, 1.25 mg/mL, 6.25 mg, 25.0 mg, 0.625 mg/mL, 12.5 mg, 7.5 mg, 6.25 mg/mL, 3.125 mg/mL, 9.75 mg/mL, 5.0 mg, 10.0 mg, 0.0125 mg/mg, 12.5 mg/mL, 1.0 mg/mL, 20.0 mg, 0.75 mg/mL, 135.0 mg/mL, 10.5 mg, 9.78 mg/mL, 0.4167 mg/mL, 6.5 mg, 7.5 mg/mL, 1.2 mg/mL, 6.0 mg/mL

, Oral, Liquid - Oral, Capsule, liquid filled, Liquid, Capsule, liquid filled - Oral, Solution - Oral, Solution, Tablet, Tablet - Oral, Powder, for solution - Oral, Kit, Tablet, effervescent - Oral, Tablet, effervescent, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Tablet, film coated - Oral, Tablet, film coated, Capsule, Capsule - Oral, Syrup - Oral, Syrup, Powder, for solution, Kit - Oral, Kit; Tablet, Kit; Tablet - Oral, Capsule; Kit - Oral, Capsule; Kit, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, coated - Oral, Tablet, coated, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral

Gastrointestinal distress

, 1.25 mg/mL, 6.25 mg, 25.0 mg, 0.625 mg/mL, 12.5 mg, 7.5 mg, 6.25 mg/mL, 3.125 mg/mL, 9.75 mg/mL, 5.0 mg, 10.0 mg, 0.0125 mg/mg, 12.5 mg/mL, 1.0 mg/mL, 20.0 mg, 0.75 mg/mL, 135.0 mg/mL, 10.5 mg, 9.78 mg/mL, 0.4167 mg/mL, 6.5 mg, 7.5 mg/mL, 1.2 mg/mL, 6.0 mg/mL

, Oral, Liquid - Oral, Capsule, liquid filled, Liquid, Capsule, liquid filled - Oral, Solution - Oral, Solution, Tablet, Tablet - Oral, Powder, for solution - Oral, Kit, Tablet, effervescent - Oral, Tablet, effervescent, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Tablet, film coated - Oral, Tablet, film coated, Capsule, Capsule - Oral, Syrup - Oral, Syrup, Powder, for solution, Kit - Oral, Kit; Tablet, Kit; Tablet - Oral, Capsule; Kit - Oral, Capsule; Kit, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, coated - Oral, Tablet, coated, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral

Catarrh

, 1.25 mg/mL, 6.25 mg, 25.0 mg, 0.625 mg/mL, 12.5 mg, 7.5 mg, 6.25 mg/mL, 3.125 mg/mL, 9.75 mg/mL, 5.0 mg, 10.0 mg, 0.0125 mg/mg, 12.5 mg/mL, 1.0 mg/mL, 20.0 mg, 0.75 mg/mL, 135.0 mg/mL, 10.5 mg, 9.78 mg/mL, 0.4167 mg/mL, 6.5 mg, 7.5 mg/mL, 1.2 mg/mL, 6.0 mg/mL

, Oral, Liquid - Oral, Capsule, liquid filled, Liquid, Capsule, liquid filled - Oral, Solution - Oral, Solution, Tablet, Tablet - Oral, Powder, for solution - Oral, Kit, Tablet, effervescent - Oral, Tablet, effervescent, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Tablet, film coated - Oral, Tablet, film coated, Capsule, Capsule - Oral, Syrup - Oral, Syrup, Powder, for solution, Kit - Oral, Kit; Tablet, Kit; Tablet - Oral, Capsule; Kit - Oral, Capsule; Kit, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, coated - Oral, Tablet, coated, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral

Symptoms Flu

, 1.25 mg/mL, 6.25 mg, 25.0 mg, 0.625 mg/mL, 12.5 mg, 7.5 mg, 6.25 mg/mL, 3.125 mg/mL, 9.75 mg/mL, 5.0 mg, 10.0 mg, 0.0125 mg/mg, 12.5 mg/mL, 1.0 mg/mL, 20.0 mg, 0.75 mg/mL, 135.0 mg/mL, 10.5 mg, 9.78 mg/mL, 0.4167 mg/mL, 6.5 mg, 7.5 mg/mL, 1.2 mg/mL, 6.0 mg/mL

, Oral, Liquid - Oral, Capsule, liquid filled, Liquid, Capsule, liquid filled - Oral, Solution - Oral, Solution, Tablet, Tablet - Oral, Powder, for solution - Oral, Kit, Tablet, effervescent - Oral, Tablet, effervescent, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Tablet, film coated - Oral, Tablet, film coated, Capsule, Capsule - Oral, Syrup - Oral, Syrup, Powder, for solution, Kit - Oral, Kit; Tablet, Kit; Tablet - Oral, Capsule; Kit - Oral, Capsule; Kit, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, coated - Oral, Tablet, coated, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral

Insomnia

, 1.25 mg/mL, 6.25 mg, 25.0 mg, 0.625 mg/mL, 12.5 mg, 7.5 mg, 6.25 mg/mL, 3.125 mg/mL, 9.75 mg/mL, 5.0 mg, 10.0 mg, 0.0125 mg/mg, 12.5 mg/mL, 1.0 mg/mL, 20.0 mg, 0.75 mg/mL, 135.0 mg/mL, 10.5 mg, 9.78 mg/mL, 0.4167 mg/mL, 6.5 mg, 7.5 mg/mL, 1.2 mg/mL, 6.0 mg/mL

, Oral, Liquid - Oral, Capsule, liquid filled, Liquid, Capsule, liquid filled - Oral, Solution - Oral, Solution, Tablet, Tablet - Oral, Powder, for solution - Oral, Kit, Tablet, effervescent - Oral, Tablet, effervescent, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Tablet, film coated - Oral, Tablet, film coated, Capsule, Capsule - Oral, Syrup - Oral, Syrup, Powder, for solution, Kit - Oral, Kit; Tablet, Kit; Tablet - Oral, Capsule; Kit - Oral, Capsule; Kit, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, coated - Oral, Tablet, coated, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral

Rhinitis, Allergic, Seasonal

, 1.25 mg/mL, 6.25 mg, 25.0 mg, 0.625 mg/mL, 12.5 mg, 7.5 mg, 6.25 mg/mL, 3.125 mg/mL, 9.75 mg/mL, 5.0 mg, 10.0 mg, 0.0125 mg/mg, 12.5 mg/mL, 1.0 mg/mL, 20.0 mg, 0.75 mg/mL, 135.0 mg/mL, 10.5 mg, 9.78 mg/mL, 0.4167 mg/mL, 6.5 mg, 7.5 mg/mL, 1.2 mg/mL, 6.0 mg/mL

, Oral, Liquid - Oral, Capsule, liquid filled, Liquid, Capsule, liquid filled - Oral, Solution - Oral, Solution, Tablet, Tablet - Oral, Powder, for solution - Oral, Kit, Tablet, effervescent - Oral, Tablet, effervescent, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Tablet, film coated - Oral, Tablet, film coated, Capsule, Capsule - Oral, Syrup - Oral, Syrup, Powder, for solution, Kit - Oral, Kit; Tablet, Kit; Tablet - Oral, Capsule; Kit - Oral, Capsule; Kit, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, coated - Oral, Tablet, coated, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral

Warnings

There are 20 known major drug interactions with Diclegis.

Common Diclegis Drug Interactions

Drug Name

Risk Level

Description

Aclidinium

Major

The risk or severity of adverse effects can be increased when Doxylamine is combined with Aclidinium.

Azelastine

Major

Doxylamine may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Cimetropium

Major

The risk or severity of adverse effects can be increased when Doxylamine is combined with Cimetropium.

Eluxadoline

Major

The risk or severity of constipation can be increased when Doxylamine is combined with Eluxadoline.

Glycopyrronium

Major

The risk or severity of adverse effects can be increased when Doxylamine is combined with Glycopyrronium.

Diclegis Toxicity & Overdose Risk

Signs of an overdose on Montelukast include wheezing, chest tightness, fever, itching, a severe cough, skin discoloration, seizures, and swelling of the face, lips, tongue, or throat.

image of a doctor in a lab doing drug, clinical research

Diclegis Novel Uses: Which Conditions Have a Clinical Trial Featuring Diclegis?

Condition

Clinical Trials

Trial Phases

Insomnia

0 Actively Recruiting

Gastrointestinal distress

9 Actively Recruiting

Phase 2, Early Phase 1, Phase 1, Phase 3, Not Applicable, Phase 4

Catarrh

0 Actively Recruiting

Rhinitis, Allergic, Seasonal

0 Actively Recruiting

Nausea and Vomiting

7 Actively Recruiting

Phase 2, Phase 3, Not Applicable, Phase 4

Symptoms Flu

0 Actively Recruiting

Diclegis Reviews: What are patients saying about Diclegis?

5

Patient Review

10/25/2017

Diclegis for Nausea and Vomiting of Pregnancy

I had a great experience with this drug, and would recommend it to anyone. The only downside is the cost, which can be prohibitive for some people.

5

Patient Review

7/21/2015

Diclegis for Nausea and Vomiting of Pregnancy

Diclegis has been an absolute lifesaver for me. I was so sick starting at 4 weeks, and when I went to the doctor at 6 weeks she prescribed this medication. It's really helped me a lot; I only take two pills before bed and I feel fine all day long.

5

Patient Review

8/27/2015

Diclegis for Nausea and Vomiting of Pregnancy

I was really struggling with my MS, to the point where I considered abortion. But then I took this pill and it completely changed everything. I'm so thankful for it.

5

Patient Review

10/1/2015

Diclegis for Nausea and Vomiting of Pregnancy

Diclegis was a life-saver for me during my third pregnancy. I had morning sickness all day long, and this medication really helped me get some relief and get back to my normal self.

5

Patient Review

10/12/2016

Diclegis for Nausea and Vomiting of Pregnancy

This drug is wonderful! I was feeling so sick during my first trimester, but after just one dose of this medicine, I felt great. It made such a big difference in how I was feeling that I could tell if I forgot to take a dose.

5

Patient Review

8/24/2019

Diclegis for Nausea and Vomiting of Pregnancy

I'm on my third pregnancy, and as anyone who's been pregnant before knows, nausea is unfortunately a common symptom. I tried other treatments but found them to be ineffective. Diclegis has really helped me out and made it much easier to handle the nausea.

5

Patient Review

8/27/2015

Diclegis for Nausea and Vomiting of Pregnancy

This treatment is fantastic. I feel great and have more energy. It's a nice reminder that pregnancy isn't always 9 months of feeling terrible.

5

Patient Review

10/22/2015

Diclegis for Nausea and Vomiting of Pregnancy

I was struggling with nausea during my first pregnancy, to the point where I could only eat one meal a day. Once I started taking diclegis, I felt so much better! My friend who was on zofran had similar results; she found relief within hours of taking it.

5

Patient Review

7/26/2016

Diclegis for Nausea and Vomiting of Pregnancy

This was prescribed for morning sickness and the sleeping part was a bonus. It kicked in really fast and has stopped my morning sickness completely. I'm only taking one instead of two like prescribed though because it knocks me out on just one.

3.3

Patient Review

5/10/2015

Diclegis for Nausea and Vomiting of Pregnancy

The drowsiness this medication caused was really debilitating. I couldn't function at all while taking it, and it wasn't even safe for me to be driving or taking care of my child.

2.7

Patient Review

4/10/2016

Diclegis for Nausea and Vomiting of Pregnancy

I was given this medication for nausea, and it did help with that. However, I felt incredibly exhausted after taking the first dose. To the point where I fell asleep while my toddler was playing (very unsafe). This continued even after a few more days of taking the medication, so I've decided to get rid of it.

2.3

Patient Review

10/8/2015

Diclegis for Nausea and Vomiting of Pregnancy

I'm on my second pregnancy and was prescribed this medication for severe nausea and vomiting. It worked great the first day, but I've slowly been getting worse over the past two weeks. I still vomit at least once a day and my nausea is all day long. I'm tired all the time and can barely find energy to play with my 2 year old.

2.3

Patient Review

9/23/2015

Diclegis for Nausea and Vomiting of Pregnancy

I would not recommend this medicine to anyone. I've been experiencing extreme mood swings and other unpleasant side effects for the last six hours, and it's supposed to last up to 12 hours.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about diclegis

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why was Diclegis taken off the market?

"The company Duchesnay applied to start selling the same two active ingredients, under the name Diclegis, that were voluntarily withdrawn from the American market in 1983. This was due to falling sales and rising legal costs."

Answered by AI

Is Diclegis just Unisom and B6?

"Diclegis is a combination of vitamin B6 and doxylamine, which is an antihistamine, sold for around $6 per pill. It is for women who might need to take up to four tablets a day."

Answered by AI

What does Diclegis do?

"Doxylamine with pyridoxine is a combination medication that is used to help relieve nausea and vomiting during pregnancy. This can improve your health and nutrition during pregnancy."

Answered by AI

Is Zofran better than Diclegis?

"Pregnant women who were given ondansetron reported greater reduction in both nausea and vomiting than those who received doxylamine-pyridoxine."

Answered by AI

Clinical Trials for Diclegis

Image of Montefiore Medical Center in Bronx, United States.

Fosaprepitant vs Metoclopramide for Nausea and Vomiting

18+
All Sexes
Bronx, NY

The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.

Phase 4
Waitlist Available

Montefiore Medical Center (+1 Sites)

Benjamin Friedman, MD

Image of Brigham and Women's Hospital in Boston, United States.

Low Thermal Plasma for Marginal Ulcers

18+
All Sexes
Boston, MA

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.

Recruiting
Has No Placebo

Brigham and Women's Hospital

Christopher C. Thompson, MD, MSc

Have you considered Diclegis clinical trials?

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Have you considered Diclegis clinical trials?

We made a collection of clinical trials featuring Diclegis, we think they might fit your search criteria.
Go to Trials