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Is Unisom Vegan?

Nov 30, 2023
3 min read

Updated: Sep 8

As of January 2025, Sanofi, the manufacturer of Unisom, could no longer verify the animal-free status of Unisom SleepMelts and Unisom PM Pain. For detailed answers to frequently asked questions about each product, please visit the FAQs section on their website at https://www.unisom.com/en-us.

Insomnia: Difficulty Sleeping

According to the Centers for Disease Control and Prevention (CDC), it's estimated that 8.4% of adults in 2020 used sleep medications in the last 30 days either every day or most days to help them fall or stay asleep. Whether it's the stress of daily life, the glow of screens, or the constant chatter of thoughts, there's no lack of factors that can disrupt our sleep.


Effects of Lack of Sleep

According to the American Academy of Sleep Medicine and Sleep Research Society, a consensus was developed that adults should sleep 7 hours or more at night regularly. Additionally, consistently getting fewer than 7 hours of sleep each night is linked to negative health effects.

​Short-term Effects

Long-term Effects

  • Stress

  • Pain, headache, fatigue, abdominal discomfort

  • Emotional distress, mental health problems, cognition, memory, performance deficits

  • Cardiovascular Issues

  • Weight gain

  • Diabetes

  • Cancer

  • Higher likelihood of death

What is Unisom?

Unisom (manufactured by Sanofi) is the brand name for several sleep-aid formulations that are available as softgels, capsules, tablets, and dissolvable tablets. It is used for short-term management of sleep difficulties in persons 12 years of age and older. Active ingredients can consist of antihistamines diphenhydramine or doxylamine, with varying types of inactive ingredients. Antihistamines work by blocking the effects of histamine and promoting sleep through sedative effects. Doxylamine typically has longer-lasting sedative effects.


Unlike prescribed medications for sleep, Unisom sleep-aids are non-addictive or habit-forming. Unisom PM Pain is different than the others since it contains a combination of diphenhydramine and acetaminophen. The acetaminophen is added to provide minor pain relief.


Precautions

Unisom Side Effects & Precautions

Unisom is a product that is generally considered safe and effective when taken as directed, but it is recommended to consult your doctor or pharmacist before taking new medications. Some precautions are:

  • Drowsiness: avoid with alcohol

  • Dizziness and dry mouth

  • Glaucoma

  • Trouble urinating due to an enlarged prostate

  • Consult with your doctor or pharmacist before use during pregnancy and lactation

  • Consult with your doctor if lack of sleep persists for longer than 2 weeks with the use of Unisom

Diphenhydramine is included in the Beers Criteria List due to its potential adverse effects in older adults (over 65 years old).


Available Unisom Products

​Medication

​Active Ingredient

Strength

Is it Animal-Free?

​Unisom SleepGels

​Diphenhydramine HCl

50 mg

No

(Gelatin)

​Unisom SleepMinis

​Diphenhydramine HCl

25 mg

No

(Gelatin & Lactose)

​Unisom SleepMelts

​Diphenhydramine HCl

25 mg

No

(Manufacturer could not confirm)

​Unisom PM Pain

​Diphenhydramine HCl & Acetaminophen

25 mg & 325 mg

No

(Manufacturer could not confirm)

Doxylamine Succinate

25 mg

Yes


Conclusion

Histamine is a natural chemical produced by the body that is important in regulating our sleep-wake cycle and cognitive function. Antihistamine sleep-aids, such as Unisom, are readily available over-the-counter (OTC) for short-duration use as needed. Because finding an animal-free sleep-aid can be difficult (fun fact: there are over 1,000 diphenhydramine containing products available!), our team has done the research to bring you animal-free options!


CALL TO ACTION

This is a great opportunity for Unisom (by Sanofi) to embrace label transparency. As a reminder, please comment on this FDA Citizen Petition, requesting clear labeling of animal-derived ingredients in medications. Together, we can make a difference.


Co-authored by: Tureye Abdulla

Verified by: Jasmine Uchi, PharmD

Disclaimer: The product and/or information provided on Pill Clarity is of a general nature and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. We do not lab test the products to confirm that they are free from animal ingredients, and it is possible that the formulation and ingredients could have changed. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or product. The information provided in this post is accurate and up to date as of the date it was written. However, please note that circumstances and facts may change over time, and new information may become available that could alter the accuracy or relevance of the content. We encourage readers to verify and cross-reference any information provided here with trusted sources or consult relevant professionals for the most current and accurate updates.



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12 Comments


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emma smith
5 days ago

Some Unisom products may contain animal ingredients such as gelatin, honey, or other additives of animal origin. basketball random

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This is a helpful topic for anyone trying to make informed, vegan-friendly medication choices. Checking inactive ingredients and understanding differences between Unisom formulations is especially important. I appreciate the focus on transparency and careful research. Consulting a pharmacist and confirming current manufacturer information can also help consumers choose suitable sleep aids safely.

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Vincent
Vincent
Sep 10

This is a helpful reminder that determining whether a medication is vegan can be more complicated than simply checking the active ingredient. AI Clothes Changer Formulations and sourcing can change over time, so verifying the latest information directly with the manufacturer is important, especially for people who want to avoid animal-derived ingredients.

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