Products
The mixture of Sanalepsi solution (active ingredient: doxylamine 10 mg/ml) with valerian tincture is prepared in pharmacies as an in-house preparation. Because the sleeping pill and sedative Sanalepsi has been reclassified to dispensing category B (ex-list C) in 2019, dispensing in pharmacies must be done by the pharmacist. A consultation is required and dispensing must be documented. A physician’s prescription as an extemporaneous prescription is also possible.
Manufacture
The common preparation is a 1:1 mixture of volumes, which can be made with a graduated cylinder:
- Sanalepsi solution: 50 ml
- Valerian tincture: 50 ml
The liquid is transferred with the help of a funnel into a medicine bottle with a pipette or dropper. Expiration after opening: 6 months (applies to Sanalepsi).
Effects
Doxylamine and valerian have sedative, sleep-inducing, antianxiety, and anticholinergic properties.
Indications for use
For short-term treatment of restlessness, nervousness, and sleep disorders.
Dosage
For adults:
- For sleep disorders: Single dose of 25 drops half an hour before bedtime.
- As a sedative: 25 drops up to 3 times a day with meals.
Contraindications
- Hypersensitivity
- Acute asthma attack
- Narrow-angle glaucoma
- Pheochromocytoma
- Bladder emptying disorder with residual urine formation
- Epilepsy
- Concurrent therapy with MAO inhibitors
- Children and adolescents
- Pregnancy, lactation
Full precautions can be found in the drug labeling information for both products.
Interactions
Central depressant drugs, alcohol, and anticholinergics may increase adverse effects and should not be combined.
Adverse effects
Possible adverse effects include (selection):
- Fatigue, decrease in responsiveness.
- Anticholinergic side effects such as dry mouth, visual disturbances, constipation, urinary retention.
- Digestive problems
- Dependence