Donormil (Doxylamine) 15 mg, 30 tablets

What is Donormil (Doxylamine)?

Donormil (Doxylamine) is a medicine used for short-term sleep problems. It contains doxylamine succinate, an antihistamine that can cause drowsiness. This type of medicine is designed to help with occasional or temporary difficulty falling asleep. Donormil (Doxylamine) is intended for adults and should be taken only as directed on the product instructions. Because sleep issues can have many different causes, this medicine is typically used for brief periods rather than long-term daily use. If sleep difficulties continue, it is important to review the situation with a healthcare professional to identify possible underlying factors and the safest next steps.

What is Donormil (Doxylamine) 15 mg used for?

Donormil (Doxylamine) 15 mg tablets are indicated for periodic or transient insomnia, meaning occasional short-term trouble sleeping. This use aligns with situations where sleep disruption is not constant and may be linked to temporary stress, schedule changes, or other short-lived factors. Insomnia can have many possible causes that do not always require medicine, so Donormil (Doxylamine) is generally positioned as a short-course option when non-medicine approaches are not enough.

Who should not use Donormil (Doxylamine)?

Do not use Donormil (Doxylamine) if any of the following apply.

These restrictions are important for safe use and should be checked carefully before taking the first dose.

• Allergy or hypersensitivity to antihistamines or to any ingredient in the product
• Closed-angle glaucoma (personal history or family history)
• Urethroprostatic disorders with a risk of urinary retention
• Breastfeeding period
• Age under 15 years

What interactions should you be aware of?

Some combinations can increase drowsiness and reduce attention, which may be dangerous when driving or using machinery. Avoid alcoholic drinks and medicines that contain alcohol, because alcohol can intensify the sedative effect of antihistamines.

Also use extra caution with medicines that can increase anticholinergic effects (such as dry mouth, constipation, and urinary retention). These may include atropine and medicines with atropine-like action, certain tricyclic antidepressants, anticholinergic antiparkinsonian medicines, specific antispasmodics, disopyramide, phenothiazine antipsychotics, and other products that act similarly.

Other medicines that depress the central nervous system can add to sleepiness and slowed reactions. This may include morphine derivatives (for example, some pain relievers, cough suppressants, and substitution therapy medicines), antipsychotics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics, sedating antidepressants (such as amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedating H1 blockers, centrally acting antihypertensives, baclofen, pizotifen, thalidomide, sodium oxybate, and other sleeping medicines.

What important warnings and precautions come with Donormil (Doxylamine)?

Donormil (Doxylamine) may worsen existing sleep apnea because sedative medicines can increase the number and duration of breathing pauses during sleep. It also contains lactose (about 100 mg per tablet), so it is not suitable in cases of congenital galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency.

Cases of misuse and dependence have been reported, even though the overall risk is considered low. The recommended course of use should not exceed 5 days. People with a history of medicine-related substance use disorders are generally advised not to take Donormil (Doxylamine).

In older adults, and in people with kidney or liver impairment, the medicine may stay in the body longer and blood levels may increase. In these situations, a lower dose may be recommended to reduce the risk of excessive sedation, slowed reactions, dizziness, falls, and cognitive effects.

How do you take Donormil (Doxylamine) 15 mg tablets?

Donormil (Doxylamine) is taken by mouth once daily in the evening, about 15 to 30 minutes before bedtime, with a small amount of water. It is intended for adults. The usual recommended dose is 7.5 mg to 15 mg per day, which is half a tablet or one tablet. If needed, the dose may be increased up to 30 mg per day, which is two tablets. Older adults and people with kidney or liver impairment are generally advised to reduce the dose.

Treatment duration is typically 2 to 5 days. If insomnia continues, the situation should be reassessed by a healthcare professional.

Can Donormil (Doxylamine) affect driving or operating machinery?

Yes. Donormil (Doxylamine) can cause daytime sleepiness and reduced attention, which may be dangerous when driving or using machinery. This risk increases when sleep time is too short. Combining it with alcohol or other sedative medicines can further worsen these effects.

What side effects may occur with standard use?

Side effects can happen, and some may require dose reduction or medical advice. Rarely reported reactions include the following.

• Daytime drowsiness (dose reduction may be needed)
• Visual disturbances
• Palpitations (fast or noticeable heartbeat)
• Dry mouth, constipation
• Urinary retention
• Confusion
• Rhabdomyolysis
• Increased blood creatine phosphokinase
• Cognitive and psychomotor impairment

What should you know about overdose?

Overdose symptoms may include drowsiness or agitation, enlarged pupils, difficulty focusing vision, dry mouth, flushing of the face and neck, increased body temperature, fast heart rate, coordination problems, and seizures. Severe poisoning has been associated with rhabdomyolysis, which can lead to acute kidney failure. If overdose is suspected, seek urgent medical help. Early management may include activated charcoal as directed by healthcare professionals.

What is in Donormil (Doxylamine) 15 mg tablets?

Each tablet contains doxylamine succinate 15 mg as/provider the active ingredient. Other ingredients include lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate. The coating includes hypromellose, macrogol 6000, purified water, and a pigment dispersion containing hypromellose, titanium dioxide, propylene glycol, and purified water.

What does the tablet look like and how is it supplied?

The tablets are white, rectangular, film-coated, and have a score line on both sides. Donormil (Doxylamine) 15 mg may be supplied as 10 or 30 film-coated tablets in a polypropylene tube with a polyethylene cap, packed in a carton.

How should Donormil (Doxylamine) be stored?

Store in the original packaging at a temperature not above 30°C (86°F).

Keep out of reach of children. Do not use after the expiration date.

The shelf life is 3 years under proper storage conditions.