Desmoda

Desmoda is used to manage central diabetes insipidus as an antidiuretic replacement therapy for adults and children. It is an oral solution given twice daily initially and individualized according to the diurnal pattern of response.

Central diabetes insipidus is a rare but serious condition caused by inadequate production of the hormone vasopressin from the hypothalamus/posterior pituitary. Desmoda is not used to treat nephrogenic diabetes insipidus.

Desmoda (desmopressin acetate) gained FDA approval on February 25, 2026, and is the first desmopressin oral solution to be approved. Desmopressin acetate has been approved since 1978, and is also available as an injection, nasal spray, and a sublingual tablet.

Take Desmoda exactly as your healthcare provider tells you to take it.

• Take Desmoda by mouth on an empty stomach, at least 1 hour before or 2 hours after food.
• Use the oral syringe provided by the pharmacy.
• Do not stop taking Desmoda without talking to your healthcare provider.

If you take too much Desmoda, call your healthcare provider right away or go to the nearest emergency room.

Desmoda may cause serious side effects, including:

• Low levels of salt (sodium) in the blood (hyponatremia). Hyponatremia has happened in people taking desmopressin acetate, an ingredient in Desmoda. Drinking excessive fluids during treatment with Desmoda may lead to water toxicity with hyponatremia. Hyponatremia can lead to death if not treated. Talk to your healthcare provider about fluid limits during treatment with Desmoda.

Do not drink more than you need to satisfy your thirst. You can have serious side effects, such as seizures, coma, and death, from drinking too much fluid.

Children and the elderly are at higher risk for these problems and should follow their healthcare provider’s limits on drinking fluids.

Tell your healthcare provider if you have any of the following signs or symptoms:

• Headache Restlessness Loss of appetite Nausea or vomiting Tiredness Irritability Decreased sodium levels in the blood Lack of energy Muscle weakness Weight gain Disorientation Muscle spasms or cramps Abnormal mental status (hallucinations, decreased consciousness, or confusion) Weakened reflexes.

Your healthcare provider will change the dose of Desmoda depending on your response. Tell your healthcare provider if you cannot swallow medicines by mouth.

People who have taken desmopressin acetate nasal spray previously should start taking the oral solution twelve hours after the last nasal spray dose. Your healthcare provider should monitor you closely during this period.

Your healthcare provider may monitor your sodium levels during your treatment with Desmoda.

Do not take Desmoda if you:

• Have or have had low levels of sodium in the blood.
• Are allergic to desmopressin acetate or any of the ingredients in Desmoda. See the end of this Medication Guide for a complete list of ingredients in Desmoda.
• Have moderate to severe kidney problems.

Before you take Desmoda, tell your healthcare provider about all of your medical conditions, including if you:

• Have heart failure or blood circulation problems
• Are thirsty much of the time and drink excessive amounts of fluids (polydipsia)
• Have or have had low levels of sodium in your blood (hyponatremia)
• Have high blood pressure that is not controlled
• Have increased pressure in your brain (increased intracranial pressure)
• Have had problems with emptying your bladder (urinary retention)
• Are pregnant or plan to become pregnant. It is not known if Desmoda will harm your unborn baby
• Are breastfeeding or plan to breastfeed. Desmoda can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Desmoda.

Use of Desmoda in children requires careful fluid restriction to prevent hyponatremia with water intoxication.

In seniors, your healthcare provider needs to carefully select the dose of Desmoda and will monitor renal function. They may restrict your intake of fluids to prevent hyponatremia with water intoxication.

The risk of side effects may be greater in patients with renal impairment, compared to patients with normal renal function.

Desmoda works by binding to vasopressin 2 (V2) receptors, found in the kidneys, specifically in the distal convoluted tubule and collecting ducts. These receptors control how much water the kidneys reabsorb and how concentrated the urine becomes, helping the body maintain its fluid balance.

Desmoda (desmopressin acetate) belongs to the drug class called vasopressin analogs.

Common Side Effects

The most common side effects of Desmoda are:

• Headache
• Dizziness
• Nausea
• Stomach pain
• High blood pressure
• Diarrhea.

Serious Side Effects

Desmoda may cause other serious side effects, including:

• Fluid retention. Desmopressin acetate, an ingredient in Desmoda, taken as an injection can cause you to retain fluid in the body. This can make existing health problems worse that are affected by changes in your body’s fluid levels.
• Allergic reactions. Allergic reactions, including a severe reaction known as anaphylaxis, have happened in people who received desmopressin acetate through a vein (intravenous) or through the nose (nasal). Tell your healthcare provider right away or get emergency medical help if you get any of the following symptoms: Swelling of the face, lips, or tongue Feeling dizzy or faint Trouble breathing or swallowing Rash or hives
• Risk of benzyl alcohol toxicity in newborn babies. Serious side effects that can lead to death have happened in low-birth-weight and preterm newborns who received medicines through their vein that contained benzyl alcohol. Desmoda contains benzoic acid, a breakdown product of benzyl alcohol.

These are not all the possible side effects of Desmoda. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Desmoda for Central Diabetes Insipidus

• Starting dosage (Adults and pediatrics): 0.05 mg orally 2 times daily
• Titrate the daily dosage as needed to obtain an adequate antidiuretic

Notes:

• Your doctor will talk to you before you start treatment with Desmoda about appropriate fluid restrictions.
• Take on an empty stomach, at least 1 hour before or 2 hours after food.
• Monitor response by measuring urine volume and osmolarity.
• For patients with central diabetes insipidus switching to Desmoda from desmopressin acetate nasal spray, wait twelve hours after the last dose. Monitor patients closely during the initial dose titration period.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines, food and drink can affect the way that Desmoda works and may mean that your healthcare provider needs to change the prescribed dose of Desmoda. Especially tell your doctor if you take:

• Other medications that increase the risk of hyponatremia (low sodium levels), such as tricyclic antidepressants, SSRIs, thiazide diuretics, and opioid analgesics
• Other vasoconstrictors, such as pseudoephedrine, epinephrine, or vasopressin. Concomitant use may increase blood pressure and require a lower dose of Desmoda.

This is not a complete list of side effects. See the Desmoda Prescribing Information for a complete list.

Store Desmoda in a refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C).

Do not freeze Desmoda.

After the bottle has been opened, use Desmoda within 120 days. Throw Desmoda away if it has not been used within 120 days.

Keep out of the reach of children.

Active ingredient: desmopressin acetate

Inactive ingredients: benzoic acid, sodium benzoate, and purified water.

Desmoda is manufactured for Eton Pharmaceuticals, Inc. by Tulex Pharmaceuticals, Inc., 5 Cedarbrook Dr., Cranbury, NJ 08512, USA. DesmodaTM is a trademark of Eton Pharmaceuticals, Inc.