Take Sleep-eze Extra Strength GelCaps to help relieve occasional nighttime sleeplessness and insomnia.
FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, pharmaceutical ink, purified water, sorbitol.
For occasional sleeplessness only.
Do not exceed recommended dose except on the advice of a physician.
If sleeplessness persists continuously for more than 2 weeks, consult your physician. Insomnia may be a symptom of serious underlying medical illness.
Do not take this product if you have glaucoma, chronic lung disease, difficulty in urination due to an enlargement of the prostate gland, or if you are pregnant or breastfeeding, unless directed by a physician
Avoid alcoholic beverages while taking this product.
If you are presently taking a prescription drug or other medication, do not take this product without first consulting your physician or pharmacist.
Not to be used by elderly patients who experience confusion at nighttime. These drugs may produce excitation rather than sedation in the elderly. Therefore they should be avoided in this age group.
Adults and children 12 years of age and older:
Take 1 capsule before going to bed if needed.
Do not increase dosage unless recommended by a physician.
Diphenhydramine, like that in Sleep-Eze Extra Strength Gelcaps, is a first-generation antihistamine mainly used to treat allergies. It can also be used for insomnia, symptoms of the common cold, tremor in parkinsonism, and nausea.
Maximal effect is typically around two hours after a dose, and effects can last for up to seven hours.
Common side effects include sleepiness, poor coordination and an upset stomach. Its use is not recommended in young children or the elderly. There is no clear risk of harm when used during pregnancy;
but because of it's marked sedative effects, diphenhydramine is reserved for cases of significant pruritus. Use during breastfeeding is not recommended as it is excreted in breast milk.
The most prominent side effect is sedation. A typical dose creates driving impairment equivalent to a blood-alcohol level of 0.10, which is higher than the 0.08 limit of most drunk-driving laws.
First-generation antihistamines can also cause:
• Dry mouth and dry eyes
• Memory loss, problems with concentration and confusion
• Urinary problems
In some people, this medication can cause a sudden drop in blood pressure leading to dizziness, especially when rising from a chair or bed. People with a history of heart disease, heart failure or glaucoma should use first-generation antihistamines with extreme caution.
Diphenhydramine is a potent anticholinergic agent. This activity is responsible for the side effects of dry mouth and throat, increased heart rate, pupil dilation, urinary retention, constipation, and, at high doses, hallucinations or delirium. Other side effects include motor impairment (ataxia), flushed skin, blurred vision at nearpoint owing to lack of accommodation (cycloplegia), abnormal sensitivity to bright light (photophobia), sedation, difficulty concentrating, short-term memory loss, visual disturbances, irregular breathing, dizziness, irritability, itchy skin, confusion, increased body temperature (in general, in the hands and/or feet), temporary erectile dysfunction, and excitability, and although it can be used to treat nausea, higher doses may cause vomiting. Diphenhydramine in overdose may occasionally result in QT prolongation.
Some individuals experience an allergic reaction to diphenhydramine in the form of hives.
Conditions such as restlessness or akathisia can worsen from increased levels of diphenhydramine, especially with recreational dosages. Normal doses of diphenhydramine, like other first generation antihistamines, can also make symptoms of restless legs syndrome worse. As diphenhydramine is extensively metabolized by the liver, caution should be exercised when giving the drug to individuals with hepatic impairment.
Anticholinergic use later in life is associated with an increased risk for cognitive decline and dementia among older people.