Doxylamine Succinate

Insomnia, Catarrh, Nausea and Vomiting + 3 more

Treatment

5 FDA approvals

10 Active Studies for Doxylamine Succinate

What is Doxylamine Succinate

Doxylamine

The Generic name of this drug

Treatment Summary

Pyridoxine is a form of Vitamin B6, a water-soluble vitamin that is found naturally in many foods. It is an essential nutrient that helps the body function properly. Animals must get pyridoxine through their diet since plants and microorganisms can make their own. Once in the body, pyridoxine is converted to pyridoxal 5-phosphate, which helps create amino acids, neurotransmitters, sphingolipids, and aminolevulinic acid. It is used to treat Vitamin B6 deficiency, prevent isoniazid-induced peripheral neuropathy

Unisom SleepTabs

is the brand name

image of different drug pills on a surface

Doxylamine Succinate 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 Doxylamine Succinate Affects Patients

Vitamin B6 (pyridoxine) is a water-soluble vitamin used to prevent and treat deficiencies and peripheral neuropathy in those taking isoniazid. In a small group of people, it has been shown to lower blood pressure, reduce platelet aggregation, lower total cholesterol, and increase good cholesterol levels. It has also been found to protect vascular endothelial cells from injury by activated platelets. Studies have also shown that vitamin B6 deficiency can have a negative impact on the immune system, leading to reduced delayed-type hypersensitivity (DTH) responses and decreased interleukin-2 production.

How Doxylamine Succinate works in the body

Vitamin B6 is a group of three related compounds that help the body in many ways. The most common type is pyridoxine. It helps with metabolism, the making of certain molecules, and the production of neurotransmitters like serotonin, dopamine, norepinephrine, and GABA.

When to interrupt dosage

The extent of Doxylamine Succinate is contingent upon the identified disorder, including Arteriosclerosis, Metabolic Acidosis and Toxinfectious state. The magnitude of dosage fluctuates according to the administration method delineated 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

Doxylamine Succinate has one contraindication, so it should not be implemented in cases of the situations set out in the following table.

There are 20 known major drug interactions with Doxylamine Succinate.

Common Doxylamine Succinate 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.

Doxylamine Succinate Toxicity & Overdose Risk

The toxic dose of this drug for a rat is 4 gm/kg, and symptoms of overdose may include seizures, difficulty breathing, excessive movement, diarrhea, lack of coordination, and weak muscles.

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

Doxylamine Succinate Novel Uses: Which Conditions Have a Clinical Trial Featuring Doxylamine Succinate?

Currently, 170 active studies are assessing the potential of Doxylamine Succinate to alleviate Nausea, Vitamin B6 Deficiency and Muscle Pain.

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

Doxylamine Succinate Reviews: What are patients saying about Doxylamine Succinate?

5

Patient Review

7/20/2019

Doxylamine Succinate for Chronic Trouble Sleeping

I had really bad anxiety after taking this. My heart rate was through the roof and I felt itchy and on fire. I'm pregnant and was recommended this by my doctor, but I'll never take it again after what happened.

5

Patient Review

9/5/2019

Doxylamine Succinate for Chronic Trouble Sleeping

I have difficulty falling asleep and often wake up after just a few hours, so I decided to give this sleep-aid a try. One half of a pill was enough to help me sleep through the night, which is great. However, I am now worried about becoming reliant on it.

5

Patient Review

1/13/2021

Doxylamine Succinate for Chronic Trouble Sleeping

Though it makes me sleepy, I often wake up feeling depressed. This morning depression really affects my daily thoughts and activities.

5

Patient Review

1/12/2022

Doxylamine Succinate for Chronic Trouble Sleeping

I initially loved this treatment, but after doing some research, I'm scared that prolonged use could lead to dementia or Alzheimer's.

4.3

Patient Review

1/26/2022

Doxylamine Succinate for Chronic Trouble Sleeping

I've taken one pill a night with a tiny amount of melatonin for years and always have the best sleep. However now I wake with terrible anxiety, lethargy and depression. It doesn’t go for a couple of hours then I am fine. It's really affecting my life so I think I may try melatonin only.

4

Patient Review

8/8/2021

Doxylamine Succinate for Chronic Trouble Sleeping

I started with a whole pill (25mg) but found that it made me too drowsy the next day, so now I stick to half a pill. It's just effective enough for me - I sleep through the night and don't feel groggy in the morning.

4

Patient Review

6/13/2020

Doxylamine Succinate for Chronic Trouble Sleeping

I got a great high from this product.

4

Patient Review

1/9/2022

Doxylamine Succinate for Chronic Trouble Sleeping

This product has helped me a lot. I take it every night and have no trouble falling asleep or staying asleep.

3.7

Patient Review

11/29/2020

Doxylamine Succinate for Chronic Trouble Sleeping

I had a severe allergic reaction to this medication which caused dizziness. I only realized this after consulting the box, which I had thrown away. Make sure you read the side effects before taking this drug!

3

Patient Review

11/16/2020

Doxylamine Succinate for Chronic Trouble Sleeping

I have no recollection of taking this sleep aid, or of what happened in the intervening time. I woke up on the bathroom floor with no idea how I got there. This product is not ideal for people who want to improve their sleep and memory.

2.7

Patient Review

8/2/2022

Doxylamine Succinate for Chronic Trouble Sleeping

I took a smaller dosage because other sleep medications have made me incredibly drowsy in the past. With this one, I felt lightheaded and woke up every hour. The dreams I had were also very strange. This medication did not help me fall asleep like it said it would.

2.3

Patient Review

3/2/2022

Doxylamine Succinate for Chronic Trouble Sleeping

I was disappointed with this product. I follow the recommended dosage and still felt wide awake.

2

Patient Review

4/19/2022

Doxylamine Succinate for Chronic Trouble Sleeping

My doctor recommended this to me when I stopped taking Mirtazapine because of weight gain. They told me to take half a tablet to avoid drowsiness the next day, but unfortunately I only got around four hours of broken sleep and woke up feeling like a zombie. It kept me awake all night and I'm exhausted today. Won't be using it again.

1.7

Patient Review

5/28/2022

Doxylamine Succinate for Chronic Trouble Sleeping

I've had terrible insomnia for years, and the pharmacist recommended Restavit. I took 1/4 tablet as directed, but unfortunately felt no effects whatsoever.

1

Patient Review

4/6/2021

Doxylamine Succinate for Chronic Trouble Sleeping

Insomnia has been a real issue for me, and I had high hopes that this drug would be the answer. Unfortunately, even taking three pills didn't help me get to sleep at all.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about doxylamine succinate

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

Does doxylamine succinate make you sleepy?

"The reason why antihistamines make you sleepy is because they cross the blood-brain barrier which mimics a natural function."

Answered by AI

Is doxylamine succinate a good sleep aid?

"There are other options that are better than doxylamine if you are considering taking sleeping pills. Doxylamine does not promote sleep in the same way as prescription sleep medications, such as benzodiazepine and non-benzodiazepine medications."

Answered by AI

What are the side effects of taking doxylamine succinate?

"Dry mouth, nose, and throat, drowsiness, nausea, increased chest congestion, headache, excitement, and nervousness are all common side effects of antihistamines."

Answered by AI

Is doxylamine succinate the same as Benadryl?

"Doxylamine succinate is a long-acting antihistamine with sedative effects. It can be found in over-the-counter sleep aids such as Unisom. It should not be used in children under 12."

Answered by AI

Clinical Trials for Doxylamine Succinate

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 Doxylamine Succinate clinical trials?

We made a collection of clinical trials featuring Doxylamine Succinate, we think they might fit your search criteria.
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Have you considered Doxylamine Succinate clinical trials?

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