Daridorexant 25mg vs 50mg: What’s the Difference?

If you're considering daridorexant for chronic insomnia, you may notice it comes in two strengths:

25mg and 50mg.

So what's the difference and does a higher dose necessarily mean better sleep?

What is the usual daridorexant dose?

According to the UK Summary of Product Characteristics, the recommended adult dose is 50mg once each night, taken within 30 minutes before going to bed.

However, based on clinical judgement, some patients may be treated with 25mg once nightly.

The maximum daily dose is 50mg.

Why might someone take 25mg instead?

25mg isn't simply a “starter dose”.

A clinician may choose it because of an individual's medical history, other medication or potential for increased exposure to daridorexant.

For example, 25mg is the recommended dose in moderate liver impairment and when daridorexant is used alongside certain moderate CYP3A4 inhibitors.

That is why selecting the dose should be a prescribing decision rather than something to adjust yourself.

Does 50mg work better than 25mg?

Clinical studies showed a dose-response relationship.

Both 25mg and 50mg improved several measures of sleep, but the 50mg dose showed statistically significant improvement versus placebo across all primary and secondary endpoints in one pivotal Phase 3 study. The product information states that efficacy generally increased with dose.

A later analysis also found stronger efficacy estimates for 50mg than 25mg, although both doses had a favourable benefit-risk profile.

That does not mean everybody should automatically take 50mg.

The best dose remains the one your clinician considers appropriate for you.

Can I increase from 25mg to 50mg myself?

No.

If 25mg doesn't seem effective enough, speak to your prescriber rather than taking additional tablets or altering your dose.

Your clinician may need to consider:

how long you've been taking treatment
your sleep pattern
daytime functioning
other medication
liver function
side effects
whether another cause of poor sleep needs investigating.

The Pharmulous approach

Insomnia treatment should be more than simply issuing the strongest tablet.

At Pharmulous, our clinicians use an online assessment to review sleep history, current medicines, medical conditions and daytime symptoms before deciding whether treatment is appropriate and which dose should be used.

If treatment continues, its effectiveness should also be reviewed.