Unisom SleepTabs, containing the active ingredient doxylamine succinate, is a leading over-the-counter (OTC) sleep aid with a well-established efficacy and safety profile. As an ethanolamine-derivative antihistamine, its primary mechanism of action is histamine H1 receptor antagonism within the central nervous system, which induces pronounced sedative effects. It is specifically formulated for the short-term relief of occasional sleeplessness, helping to reduce the time to sleep onset and decrease nighttime awakenings. This monograph provides a comprehensive, evidence-based overview for healthcare professionals and informed consumers.

Features

• Active Ingredient: Doxylamine Succinate (25 mg per tablet)
• Drug Class: Ethanolamine-class, first-generation (sedating) antihistamine
• Indication: For the short-term treatment of occasional sleeplessness
• Formulation: Film-coated tablets for easy swallowing
• Non-Habit Forming: When used as directed for short-term periods
• OTC Status: Available without a prescription

Benefits

• Promotes Rapid Sleep Onset: Clinically demonstrated to significantly decrease the amount of time it takes to fall asleep.
• Improves Sleep Maintenance: Helps reduce the frequency of nighttime awakenings, supporting a more consolidated and restful sleep period.
• Addresses Sleep Disruption Due to Environmental Factors: Effective for sleep difficulties caused by stress, travel, or minor schedule disruptions.
• Provides Predictable Pharmacokinetics: As a single-ingredient product, it offers a consistent and predictable sedative effect.
• Avoids Next-Day “Hangover” Effects for Most Users: When taken at the recommended dose and with a full 7-8 hours dedicated to sleep, residual drowsiness is minimized.

Common use

Unisom SleepTabs are indicated for the short-term management of occasional insomnia, characterized by difficulties with both sleep initiation (sleep onset latency) and sleep maintenance (nocturnal awakenings). It is commonly utilized by individuals experiencing transient sleep disturbances related to psychosocial stress, jet lag, or shift work schedule changes. Its use should be confined to periods typically not exceeding two weeks, unless a healthcare provider advises otherwise, to prevent the development of tolerance and to encourage the identification and addressing of underlying causes of insomnia.

Dosage and direction

The standard adult dosage is one 25 mg tablet taken approximately 30 minutes before bedtime. It is imperative to ensure that you can dedicate a full 7 to 8 hours to uninterrupted sleep after ingestion. The tablet should be swallowed whole with a full glass of water. Do not crush, chew, or break the tablet. This product is intended for use immediately prior to sleep initiation and not for use during waking hours. Use the smallest effective dose for the shortest duration needed to treat your symptoms. Do not exceed one tablet in 24 hours.

Precautions

• Consult a doctor or pharmacist before use if you have a medical condition, especially: emphysema, chronic bronchitis, glaucoma, asthma, or an enlarged prostate.
• Exercise caution as this drug may cause marked drowsiness. Do not drive, operate machinery, or engage in any hazardous activity until you are certain you can do so safely, which is typically at least 8 hours after ingestion.
• Avoid alcoholic beverages and other CNS depressants (e.g., sedatives, tranquilizers) while taking this medication, as the sedative effects will be additive.
• Use with caution in persons 65 years and older, as they may be more sensitive to the effects of antihistamines and may experience dizziness, sedation, and confusion, increasing the risk of falls.
• Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.

Contraindications

Unisom SleepTabs are contraindicated in patients with:

• Known hypersensitivity to doxylamine succinate or any other component of the formulation.
• Untreated narrow-angle glaucoma.
• Severe respiratory conditions, including severe asthma.
• Concomitant use with Monoamine Oxidase Inhibitors (MAOIs), due to the potential for intensified anticholinergic and sedative effects.
• Urinary retention, including that due to prostatic hypertrophy.

Possible side effect

Like all medicines, doxylamine succinate can cause side effects, although not everybody gets them. The most common side effects are directly related to its pharmacological action and include:

• Drowsiness (somnolence)
• Dizziness
• Dry mouth, nose, or throat
• Constipation
• Blurred vision Less common side effects may include:
• Nervousness
• Excitability (especially in children)
• Nausea
• Headache
• Palpitations

Drug interaction

Doxylamine succinate has the potential to interact with several classes of medication. Inform your doctor about all medicines you are taking, including prescription, OTC, and herbal products.

• CNS Depressants: Concomitant use with alcohol, sedatives, tranquilizers, barbiturates, or other sleep aids can lead to profound sedation, respiratory depression, coma, or death.
• Anticholinergic Drugs: May potentiate the effects of other drugs with anticholinergic properties (e.g., atropine, tricyclic antidepressants, some antipsychotics), increasing the risk of side effects like dry mouth, constipation, and urinary retention.
• Monoamine Oxidase Inhibitors (MAOIs): Contraindicated due to risk of intensified and prolonged anticholinergic effects.

Missed dose

Since this medication is taken on an as-needed basis at bedtime, you are not likely to be on a dosing schedule. Do not take the medication if you do not have time for a full night’s sleep before you must be active again. Never take two doses at one time to make up for a missed dose.

Overdose

In case of overdose, seek emergency medical attention or call a poison control center immediately. Overdose symptoms may be severe and include:

• Extreme drowsiness progressing to stupor or coma
• Agitation, restlessness, or hallucinations
• Seizures
• Flushed skin, fever
• Dilated pupils
• Irregular heart rate
• Respiratory depression Treatment is symptomatic and supportive. Physostigmine may be considered in severe cases with life-threatening symptoms.

Storage

Store at room temperature (20°-25°C or 68°-77°F) in a dry place. Keep the bottle tightly closed and out of direct light. Keep this and all medications out of the reach of children and pets. Do not use if the blister pack or bottle seal is broken or missing.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “As a nurse with rotating shifts, Unisom is my go-to for resetting my sleep schedule. One tablet provides 7 hours of solid sleep without grogginess, as long as I time it correctly.” – Sarah T., RN
• “I’ve tried other sleep aids, but doxylamine succinate is the only ingredient that consistently helps me both fall asleep and stay asleep. I appreciate that it’s a single active ingredient, so I know exactly what I’m taking.” – Mark D.
• “Effective for occasional use during high-stress periods. I find it crucial to drink a large glass of water with it to mitigate dry mouth. The effect is reliable and predictable.” – Linda P.
• “I use this sparingly for jet lag. It works very well, but the ‘drowsy’ warning is serious. You must commit to a full night in bed after taking it.” – James K.