Unisom SleepTabs: Clinically Proven Sleep Onset and Maintenance

Unisom

Unisom
Product dosage: 25mg
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Synonyms

Unisom SleepTabs, containing the active ingredient doxylamine succinate, is an over-the-counter (OTC) sleep aid specifically formulated for the short-term treatment of occasional insomnia. 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. This monograph provides a comprehensive, evidence-based overview for healthcare professionals and informed consumers, detailing its appropriate use, pharmacological profile, and essential safety information to support therapeutic decision-making.

Features

  • Active Ingredient: Doxylamine Succinate 25 mg per tablet.
  • Drug Class: Ethanolamine-class, first-generation (sedating) antihistamine (H1-receptor inverse agonist).
  • Formulation: Small, easy-to-swallow, blue, film-coated tablets.
  • Indication: For the relief of occasional sleeplessness and difficulty falling asleep.
  • Onset of Action: Typically induces drowsiness within 30 minutes to one hour after ingestion.
  • Duration of Action: Effects generally last for 6 to 8 hours, supporting sleep maintenance.
  • Non-Habit Forming: When used as directed for short-term periods, it is not associated with physical dependence.
  • OTC Status: Available without a prescription, but use should be informed and cautious.

Benefits

  • Promotes Rapid Sleep Onset: Effectively reduces the time taken to fall asleep, helping to break the cycle of pre-sleep anxiety and tossing and turning.
  • Supports Uninterrupted Sleep: Helps maintain sleep throughout the night, reducing mid-sleep awakenings and improving overall sleep architecture for more restorative rest.
  • Improves Sleep Quality: By facilitating a full night’s sleep, users often report waking up feeling more refreshed and less fatigued the following morning.
  • Provides Predictable Sedation: The well-characterized pharmacokinetic profile of doxylamine allows for reliable planning of sleep schedules.
  • Non-Narcotic Formula: Offers a sleep aid option that is not classified as a controlled substance or narcotic.
  • Addresses Sleep Disruption from Minor Aches/Pains: Its sedative properties can be adjunctive in managing sleep difficulties compounded by minor discomfort.

Common use

Unisom SleepTabs are indicated for the short-term management of occasional insomnia, particularly difficulties with sleep initiation. Its use is common among individuals experiencing transient sleep disturbances due to factors such as stress, irregular work schedules (e.g., jet lag, shift work), or temporary anxiety. It is crucial to emphasize that it is not intended for the long-term treatment of chronic sleep disorders, which require a thorough medical evaluation to identify and address underlying causes such as sleep apnea, restless leg syndrome, or major depressive disorder. Self-medication beyond two weeks is not recommended without consulting a healthcare provider.

Dosage and direction

The standard adult dosage is one 25 mg tablet taken approximately 30 minutes before bedtime. It is imperative to ensure that at least 7-8 hours are dedicated to sleep after ingestion to avoid next-day drowsiness (residual sedation). This product must not be taken until ready to sleep and all activities for the day are complete. The tablet should be swallowed whole with a full glass of water. Do not crush or chew. Use should be limited to the shortest duration necessary, typically not exceeding two weeks. Use in individuals under 18 years of age is not recommended unless specifically directed by a doctor.

Precautions

  • Next-Day Impairment: Doxylamine can cause significant drowsiness the next day. Exercise extreme caution when driving, operating machinery, or performing activities requiring alertness the morning after use.
  • Alcohol Warning: Concomitant use with alcoholic beverages or other CNS depressants (sedatives, tranquilizers) is absolutely contraindicated due to additive effects, dramatically increasing the risk of profound sedation, respiratory depression, and accidental injury.
  • Existing Medical Conditions: Use with caution in persons with:
    • Conditions causing urinary retention (e.g., prostatic hyperplasia).
    • Increased intraocular pressure (e.g., glaucoma).
    • Respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), or emphysema.
    • Liver or kidney impairment, which may alter the metabolism and excretion of the drug.
    • Cardiovascular disease.
  • Pregnancy and Breastfeeding: Consult a doctor before use if pregnant or breastfeeding. Antihistamines are known to pass into breast milk and may cause drowsiness or excitability in a nursing infant.
  • Elderly Patients: Individuals 65 years and older may be more sensitive to the effects of antihistamines, experiencing heightened confusion, dizziness, sedation, and a greater risk of falls. A lower dose may be advisable, and a doctor should be consulted.

Contraindications

Unisom SleepTabs are contraindicated in patients with:

  • Known hypersensitivity to doxylamine succinate or any other ingredient in the formulation.
  • Untreated or inadequately treated narrow-angle glaucoma.
  • Severe respiratory insufficiency (e.g., severe asthma).
  • Concomitant use of Monoamine Oxidase Inhibitors (MAOIs), due to the risk of anticholinergic crisis. A minimum 14-day washout period after discontinuing an MAOI is required before initiating doxylamine therapy.
  • Pre-existing urinary retention or severe prostate enlargement.
  • Concurrent use with other products containing diphenhydramine or other antihistamines, including OTC sleep, cold, and allergy medications.

Possible side effect

While generally well-tolerated for short-term use, doxylamine can produce a range of side effects due to its anticholinergic properties.

  • Very Common (>10%): Drowsiness, sedation, somnolence.
  • Common (1-10%): Dizziness, headache, dry mouth, nose, and throat.
  • Less Common (<1%): Nervousness, restlessness, excitability (especially in children), blurred vision, constipation, urinary retention, nausea, palpitations.
  • Rare: Severe allergic reactions (anaphylaxis, rash, itching, swelling), confusion, paradoxical insomnia.

Drug interaction

Doxylamine has a significant potential for pharmacodynamic interactions, primarily through additive CNS depression.

  • CNS Depressants: Potentiates the sedative effects of alcohol, benzodiazepines, opioids, barbiturates, antipsychotics, tricyclic antidepressants, skeletal muscle relaxants, and other sedating antihistamines. This combination is dangerous.
  • Anticholinergic Agents: Concurrent use with other drugs possessing anticholinergic activity (e.g., tricyclic antidepressants like amitriptyline, antispasmodics like dicyclomine, drugs for Parkinson’s disease like benztropine) can lead to an anticholinergic toxicity syndrome (fever, confusion, agitation, dry hot skin, reduced bowel sounds, urinary retention).
  • MAO Inhibitors: As noted in Contraindications, concurrent use is prohibited.

Missed dose

Since this medication is taken on an as-needed basis at bedtime, you are not likely to be on a dosing schedule. If you are prescribed a scheduled regimen and miss a dose, take it as soon as you remember only if you can then get a full 7-8 hours of sleep. If it is almost time for your next dose, skip the missed dose. Do not take two doses at one time to make up for a missed dose.

Overdose

Overdose of antihistamines like doxylamine can be life-threatening, especially in young children. Symptoms of overdose may include:

  • Extreme drowsiness progressing to stupor or coma.
  • Agitation, restlessness, hallucinations, or seizures.
  • Severe anticholinergic effects: dilated pupils, flushed, hot, dry skin, hyperthermia, tachycardia, urinary retention, reduced gastrointestinal motility.
  • Cardiovascular collapse. In case of suspected overdose, seek emergency medical attention or contact a Poison Control Center (1-800-222-1222 in the US) immediately. Hospital treatment is supportive and may include activated charcoal, IV fluids, and control of symptoms with benzodiazepines for seizures. Physostigmine may be considered in severe cases of central anticholinergic syndrome.

Storage

Store at room temperature (20°-25°C or 68°-77°F) in a dry place, away from light and moisture. Do not store in the bathroom. Keep the bottle tightly closed. Keep all medications out of the reach of children and pets to prevent accidental ingestion.

Disclaimer

This information is for educational and informational 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. The manufacturer and publisher are not responsible for any errors or omissions or for any consequences from application of the information in this document.

Reviews

  • “As a nurse with rotating shifts, Unisom is my go-to for resetting my sleep schedule. One tablet and I’m out for a solid 7 hours. The next-day grogginess is real, so I only use it on nights before my day off.” – Sarah T., RN
  • “Effective for sure, but the dry mouth is significant. I keep water by the bed. I use it very sparingly, maybe once a month during periods of high stress when my sleep is severely disrupted.” – Mark D.
  • “I’ve tried other OTC sleep aids, but doxylamine seems to be the only one that consistently works for me without any strange dreams or feeling ‘hungover,’ provided I get a full 8 hours.” – Linda P.
  • “Consulted my doctor before using this during my second trimester for pregnancy insomnia. It was a lifesaver for getting the rest I desperately needed, with my OB’s approval.” – Jenna K.
  • “Be cautious. I took it for a week straight and felt increasingly groggy and ‘out of it’ during the day. It’s powerful and should be respected as a medication, not a casual supplement.” – Robert L.

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