### SLEEPMED 25 (hydroxyzine and melatonin blend) Tablets
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use SLEEPMED 25 safely and effectively. See full prescribing information for SLEEPMED 25.
SLEEPMED 25 tablets, for oral use
**INDICATIONS AND USAGE**
SLEEPMED 25 is a sleep aid blend indicated for investigational use in promoting deep sleep, reducing stress, and supporting recovery in performance enhancement settings. Not approved for all indications in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adults (males and females): 25 mg (20 mg hydroxyzine, 5 mg melatonin) before bed (2.1).
– Duration: As needed for sleep support, typically short-term use.
**DOSAGE FORMS AND STRENGTHS**
Tablets: 25 mg (20 mg hydroxyzine, 5 mg melatonin) (3).
**CONTRAINDICATIONS**
– Hypersensitivity to hydroxyzine, melatonin, or any component of the formulation (4).
– Pregnancy (4).
**WARNINGS AND PRECAUTIONS**
– Drowsiness: May cause next-day impairment; avoid driving (5.1).
– CNS depression: Avoid alcohol or other sedatives (5.2).
– Anticholinergic effects: Monitor for dry mouth or constipation (5.3).
**ADVERSE REACTIONS**
Common adverse reactions include drowsiness, dry mouth, and dizziness (6).
**DRUG INTERACTIONS**
– CNS depressants: May enhance sedation; avoid concurrent use (7.1).
– Anticholinergics: May enhance effects; monitor closely (7.2).
**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Contraindicated (8.1).
– Lactation: Not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Increased risk of anticholinergic effects (8.5).
Revised: 08/2025
**FULL PRESCRIBING INFORMATION**
**1 INDICATIONS AND USAGE**
SLEEPMED 25 is indicated for investigational use in adults to promote deep, restorative sleep, reduce anxiety and stress, regulate circadian rhythm, support hormonal balance, enhance recovery, and improve mood and cognition. It is commonly used in performance enhancement settings to optimize rest for training recovery. This product is not approved for all indications and should be used under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer orally, 30-60 minutes before bedtime, with or without food.
– Adults (males and females): 25 mg (20 mg hydroxyzine, 5 mg melatonin) as a single dose before bed.
– Duration: Short-term use recommended; avoid prolonged daily use to prevent tolerance. Discontinue if adverse effects occur.
**2.2 Preparation and Handling**
Store tablets in original packaging to protect from light and moisture. Do not crush or chew tablets.
**3 DOSAGE FORMS AND STRENGTHS**
Tablets containing 25 mg (20 mg hydroxyzine, 5 mg melatonin), supplied in bottles of 30 tablets.
**4 CONTRAINDICATIONS**
SLEEPMED 25 is contraindicated in:
– Patients with known hypersensitivity to hydroxyzine, melatonin, or excipients (e.g., lactose monohydrate).
– Pregnant women (Category X).
**5 WARNINGS AND PRECAUTIONS**
**5.1 Drowsiness**
May cause significant next-day drowsiness, impairing activities like driving or operating machinery. Advise patients to avoid such activities until fully alert.
**5.2 CNS Depression**
May enhance central nervous system depression when combined with alcohol or other sedatives, increasing the risk of respiratory depression or sedation. Avoid concurrent use.
**5.3 Anticholinergic Effects**
Hydroxyzine component may cause dry mouth, constipation, or urinary retention, particularly in elderly patients. Monitor and adjust therapy if severe.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Nervous System: Drowsiness, dizziness, headache.
– Gastrointestinal: Dry mouth, constipation.
– General: Fatigue, lethargy.
Serious reactions may include severe sedation or hypersensitivity responses.
**7 DRUG INTERACTIONS**
**7.1 CNS Depressants**
Concurrent use with alcohol, benzodiazepines, or other sedatives may enhance sedation, increasing the risk of respiratory depression. Avoid co-administration.
**7.2 Anticholinergics**
Concurrent use with other anticholinergic drugs may enhance effects like dry mouth or constipation. Monitor closely and adjust therapy as needed.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm due to hydroxyzine’s sedative effects. Contraindicated in pregnant women.
**8.2 Lactation**
Excretion in breast milk is unknown; breastfeeding is not recommended due to potential risks to the infant.
**8.4 Pediatric Use**
Safety and efficacy not established in pediatric patients; use is not recommended.
**8.5 Geriatric Use**
Increased risk of anticholinergic effects and sedation; use with caution and monitor closely.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with SLEEPMED 25, but misuse for sedation may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include severe drowsiness, confusion, or respiratory depression. Treat symptomatically and discontinue use immediately.
**11 DESCRIPTION**
SLEEPMED 25 contains a blend of hydroxyzine (20 mg), an antihistamine with sedative properties, and melatonin (5 mg), a sleep-regulating hormone. Supplied as tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 3 hours (melatonin), 20 hours (hydroxyzine).
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Hydroxyzine provides sedation via histamine H1 receptor antagonism, while melatonin regulates circadian rhythm to promote sleep onset and quality.
**12.3 Pharmacokinetics**
Hydroxyzine is absorbed orally; peak plasma levels in 2 hours; half-life approximately 20 hours. Melatonin is absorbed rapidly; half-life approximately 3 hours. Both are metabolized in the liver; excreted primarily via urine.
**13 NONCLINICAL TOXICOLOGY**
Limited data available; animal studies suggest low toxicity for melatonin, with hydroxyzine showing potential CNS effects. No human carcinogenicity data available.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
Tablets, 25 mg (20 mg hydroxyzine, 5 mg melatonin), in bottles of 30. Store at 20°-25°C (68°-77°F); protect from light and moisture. Keep out of reach of children.
*Manufactured by: Medi Pharma*
