Doxylamine Succinate is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Nighttime Sleep Aid, Unisom SleepTabs
- Taken
- Oral
- Label
- Amazon.com Services LLC, revised September 2, 2026 · full label on DailyMed
Purpose
Nighttime sleep-aid
What it is used for
- helps to reduce difficulty in falling asleep
Active ingredient
Doxylamine succinate 25 mg
Do not use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking
- a sedative or any other sleep-aid
- tranquilizers
- any other antihistamines
- any other drugs
When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- take only at bedtime
Stop use and ask a doctor if
- sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
Warnings
Do not use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking
- a sedative or any other sleep-aid
- tranquilizers
- any other antihistamines
- any other drugs When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- take only at bedtime Stop use and ask a doctor if
- sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Doxylamine in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID c4509e0a-cb9d-454c-a67b-812a0ba62be1.