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ALMOREXANT
Generic Name: ALMOREXANT
ABSTRACT -
Almorexant is an investigational orally administered dual orexin receptor antagonist that blocks orexin OX1 and OX2 receptors. Orexin signaling promotes wakefulness, so receptor antagonism was studied as a treatment for insomnia. Development was discontinued, and almorexant is not an approved routine medicine.
DOSAGE -
- Almorexant does not have an approved routine dosage regimen.
- Clinical-study dosing was protocol-defined and should not be extrapolated for self-use.
- It should not be used for insomnia treatment outside authorized research or specialist settings.
- Patients with insomnia should use approved treatments and non-drug sleep strategies under clinician guidance.
SIDE EFFECTS–
- Reported or potential side effects may include:
- Somnolence or next-day drowsiness
- Fatigue
- Headache
- Dizziness
- Nausea
- Abnormal dreams or nightmares
- Sleep paralysis-like symptoms
- Impaired attention or coordination
- Possible liver enzyme abnormalities
- Allergic or hypersensitivity reactions
ALLRGIC REACTIONS–
(These symptoms may indicate an allergic reaction to the drug.)
- Skin rash
- Itching
- Hives
- Swelling of face, lips, tongue, or throat
- Difficulty breathing
- Wheezing
- Severe dizziness
- Rapid heartbeat
- Chest tightness
- Anaphylaxis
- Severe hypersensitivity reactions
DRUG INTERACTIONS–
- The interaction profile may include or require caution with:
- Alcohol
- Benzodiazepines, Z-drugs, opioids, sedating antihistamines, or other CNS depressants
- Other orexin receptor antagonists
- Strong CYP3A inhibitors or inducers
- Antidepressants, antipsychotics, or other medicines that affect alertness
- Medicines associated with liver toxicity
- Products that impair driving or psychomotor performance
- Patients should inform healthcare providers about all prescription medicines, non-prescription medicines, herbal products, and supplements being used.
PREAUTIONS–
- Avoid driving, machinery operation, or safety-sensitive activities after use in any research setting until next-day impairment risk is known.
- Use caution in narcolepsy, cataplexy, severe depression, sleep apnea, respiratory disease, liver disease, or substance-use disorder.
- Assess sleep disorder diagnosis and contributing medical or psychiatric conditions before pharmacologic treatment.
- Pregnancy, breastfeeding, and pediatric safety have not been established.
- Do not combine with alcohol or other sedatives.
WARNINGS –
- Almorexant is investigational and discontinued; safety, efficacy, optimal dose, and routine clinical role have not been established.
- Orexin antagonism can cause excessive sleepiness, impaired driving, abnormal sleep behaviors, or sleep-paralysis-like events.
- Severe sedation, confusion, breathing problems, unusual behavior, or allergic reaction requires medical evaluation.
- Do not use unapproved sleep medicines obtained outside regulated medical care.
- Keep out of reach of children.
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